Brian R Davidson

Gazi University, Engüri, Ankara, Turkey

Are you Brian R Davidson?

Claim your profile

Publications (390)1616.08 Total impact

  • Journal of gastrointestinal cancer. 08/2014;
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Background: The cost-effectiveness of non-invasive tests (NITs) as alternatives to liver biopsy is unknown. We compared the cost-effectiveness of using NITs to inform treatment decisions in adult patients with chronic hepatitis C (CHC).Methods: We conducted a systematic review and meta-analysis to calculate the diagnostic accuracy of various NITs using a bivariate random-effects model. We constructed a probabilistic decision analytical model to estimate health care costs and outcomes (QALYs) using data from the meta-analysis, literature, and national UK data. We compared the cost-effectiveness of four treatment strategies: testing with NITs and treating patients with fibrosis stage ≥F2, testing with liver biopsy and treating patients with ≥F2, treat none and treat all irrespective of fibrosis. We compared all NITs and tested the cost-effectiveness using current triple therapy with boceprevir or telaprevir but also modeled new, more potent antivirals.Findings: Treating all patients without any prior NIT was the most effective strategy and had an incremental cost-effectiveness ratio (ICER) of £9,204/additional QALY gained. The exploratory analysis of currently licensed sofosbuvir treatment regimens found that treat all was cost-effective compared to using an NIT to decide on treatment, with an ICER of £16,028/QALY gained. The exploratory analysis to assess the possible impact on results of new treatments, found that if SVR rates increased to >90% for genotypes 1-4, the incremental treatment cost threshold for the “treat all” strategy to remain the most cost-effective strategy would be £37,500. Above this threshold, the most cost-effective option would be non-invasive testing with MR elastography (ICER=£9,189).Conclusions: Treating all adult patients with CHC, irrespective of fibrosis stage, is the most cost-effective strategy with currently available drugs in developed countries. (Hepatology 2014)
    Hepatology 07/2014; · 12.00 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Liver resection is a major surgery with significant mortality and morbidity. Various methods have been attempted to decrease blood loss and morbidity during elective liver resection. These methods include different methods of vascular occlusion, parenchymal transection, and management of the cut surface of the liver. A surgeon typically uses only one of the methods from each of these three categories. Together, one can consider this combination as a treatment strategy. The optimal treatment strategy for liver resection is unknown. To assess the comparative benefits and harms of different treatment strategies that aim to decrease blood loss during elective liver resection. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and Science Citation Index Expanded to July 2012 to identify randomised clinical trials. We also handsearched the references lists of identified trials. We included only randomised clinical trials (irrespective of language, blinding, or publication status) where the method of vascular occlusion, parenchymal transection, and management of the cut surface were clearly reported, and where people were randomly assigned to different treatment strategies based on different combinations of the three categories (vascular occlusion, parenchymal transection, cut surface). Two review authors identified trials and collected data independently. We assessed the risk of bias using The Cochrane Collaboration's methodology. We conducted a Bayesian network meta-analysis using the Markov chain Monte Carlo method in WinBUGS 1.4 following the guidelines of the National Institute for Health and Care Excellence Decision Support Unit guidance documents. We calculated the odds ratios (OR) with 95% credible intervals (CrI) (which are similar to confidence intervals in the frequentist approach for meta-analysis) for the binary outcomes and mean differences (MD) with 95% CrI for continuous outcomes using a fixed-effect model or random-effects model according to model-fit. We identified nine trials with 617 participants that met our inclusion criteria. Interventions in the trials included three different options for vascular occlusion, four for parenchymal transection, and two for management of the cut liver surface. These interventions were combined in different ways in the trials giving 11 different treatment strategies. However, we were only able to include 496 participants randomised to seven different treatment strategies from seven trials in our network meta-analysis, because the treatment strategies from the trials that used fibrin sealant for management of the raw liver surface could not be connected to the network for any outcomes. Thus, the trials included in the network meta-analysis varied only in their approaches to vascular exclusion and parenchymal transection and none used fibrin sealant. All the trials were of high risk of bias and the quality of evidence was very low for all the outcomes. The differences in mortality between the different strategies was imprecise (seven trials; seven treatment strategies; 496 participants). Five trials (six strategies; 406 participants) reported serious adverse events. There was an increase in the proportion of people with serious adverse events when surgery was performed using radiofrequency dissecting sealer compared with the standard clamp-crush method in the absence of vascular occlusion and fibrin sealant. The OR for the difference in proportion was 7.13 (95% CrI 1.77 to 28.65; 15/49 (adjusted proportion 24.9%) in radiofrequency dissecting sealer group compared with 6/89 (6.7%) in the clamp-crush method). The differences in serious adverse events between the other groups were imprecise. There was a high probability that 'no vascular occlusion with clamp-crush method and no fibrin' and 'intermittent vascular occlusion with Cavitron ultrasonic surgical aspirator and no fibrin' are better than other treatments with regards to serious adverse events. Quality of life was not reported in any of the trials.The differences in the proportion of people requiring blood transfusion was imprecise (six trials; seven treatments; 446 participants). Two trials (three treatments; 155 participants) provided data for quantity of blood transfused. People undergoing liver resection by intermittent vascular occlusion had higher amounts of blood transfused than people with continuous vascular occlusion when the parenchymal transection was carried out with the clamp-crush method and no fibrin sealant was used for the cut surface (MD 1.2 units; 95% CrI 0.08 to 2.32). The differences in the other comparisons were imprecise (very low quality evidence). Three trials (four treatments; 281 participants) provided data for operative blood loss. People undergoing liver resection using continuous vascular occlusion had lower blood loss than people with no vascular occlusion when the parenchymal transection was carried out with clamp-crush method and no fibrin sealant was used for the cut surface (MD -130.9 mL; 95% CrI -255.9 to -5.9). None of the trials reported the proportion of people with major blood loss.The differences in the length of hospital stay (six trials; seven treatments; 446 participants) and intensive therapy unit stay (four trials; six treatments; 261 participants) were imprecise. Four trials (four treatments; 245 participants) provided data for operating time. Liver resection by intermittent vascular occlusion took longer than liver resection performed with no vascular occlusion when the parenchymal transection was carried out with Cavitron ultrasonic surgical aspirator and no fibrin sealant was used for the cut surface (MD 49.6 minutes; 95% CrI 29.8 to 69.4). The differences in the operating time between the other comparisons were imprecise. None of the trials reported the time needed to return to work. Very low quality evidence suggested that liver resection using a radiofrequency dissecting sealer without vascular occlusion or fibrin sealant may increase serious adverse events and this should be evaluated in further randomised clinical trials. The risk of serious adverse events with liver resection using no special equipment compared with more complex methods requiring special equipment was uncertain due to the very low quality of the evidence. The credible intervals were wide and considerable benefit or harm with a specific method of liver resection cannot be ruled out.
    Cochrane database of systematic reviews (Online) 04/2014; 4:CD010683. · 5.70 Impact Factor
  • S. Morris, K. S. Gurusamy, N. Patel, B. R. Davidson
    [Show abstract] [Hide abstract]
    ABSTRACT: BackgroundA recent Cochrane review suggested that laparoscopic cholecystectomy carried out early following mild gallstone pancreatitis was safe. This study compared the cost-effectiveness of laparoscopic cholecystectomy performed within 3 days of admission, during the same admission but after more than 3 days, or electively in a subsequent admission.MethodsA model-based cost–utility analysis was performed estimating mean costs and quality-adjusted life-years (QALYs) per patient in the UK National Health Service with a 1-year time horizon. A decision tree model was constructed and populated with probabilities, outcomes and cost data from published sources for mild gallstone pancreatitis, including one-way and probabilistic sensitivity analyses.ResultsThe costs of laparoscopic cholecystectomy performed within 3 days of admission, beyond 3 days but in the same admission, and electively in a subsequent admission were €2748, €3543 and €3752 respectively; the QALYs were 0·888, 0·888 and 0·884 respectively. Early laparoscopic cholecystectomy had a 91 per cent probability of being cost-effective at the maximum willingness to pay for a QALY commonly used in the UK. It is acknowledged that many hospitals do not have access to magnetic resonance cholangiopancreatography and endoscopic retrograde cholangiopancreatography, especially at weekends, and that implementing a 3-day target is unrealistic without allocating new resources that could erode the cost-effectiveness.Conclusion Performing laparoscopic cholecystectomy for mild gallstone pancreatitis within 3 days of admission is cost-effective, but may not be feasible without significant resource allocation. After 3 days there is little financial advantage to same-admission operation.
    British Journal of Surgery 04/2014; · 4.84 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: While laparoscopic cholecystectomy is generally considered less painful than open surgery, pain is one of the important reasons for delayed discharge after day-surgery and overnight stay following laparoscopic cholecystectomy. The safety and effectiveness of different pharmacological interventions such as non-steroidal anti-inflammatory drugs, opioids, and anticonvulsant analgesics in people undergoing laparoscopic cholecystectomy is unknown. To assess the benefits and harms of different analgesics in people undergoing laparoscopic cholecystectomy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Science Citation Index Expanded, and the World Health Organization International Clinical Trials Registry Platform portal (WHO ICTRP) to March 2013 to identify randomised clinical trials of relevance to this review. We considered only randomised clinical trials (irrespective of language, blinding, or publication status) comparing different pharmacological interventions with no intervention or inactive controls for outcomes related to benefit in this review. We considered comparative non-randomised studies with regards to treatment-related harms. We also considered trials that compared one class of drug with another class of drug for this review. Two review authors collected the data independently. We analysed the data with both fixed-effect and random-effects models using Review Manager 5 analysis. For each outcome, we calculated the risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI). We included 25 trials with 2505 participants randomised to the different pharmacological agents and inactive controls. All the trials were at unclear risk of bias. Most trials included only low anaesthetic risk people undergoing elective laparoscopic cholecystectomy. Participants were allowed to take additional analgesics as required in 24 of the trials. The pharmacological interventions in all the included trials were aimed at preventing pain after laparoscopic cholecystectomy. There were considerable differences in the pharmacological agents used and the methods of administration. The estimated effects of the intervention on the proportion of participants who were discharged as day-surgery, the length of hospital stay, or the time taken to return to work were imprecise in all the comparisons in which these outcomes were reported (very low quality evidence). There was no mortality in any of the groups in the two trials that reported mortality (183 participants, very low quality evidence). Differences in serious morbidity outcomes between the groups were imprecise across all the comparisons (very low quality evidence). None of the trials reported patient quality of life or time taken to return to normal activity. The pain at 4 to 8 hours was generally reduced by about 1 to 2 cm on the visual analogue scale of 1 to 10 cm in the comparisons involving the different pharmacological agents and inactive controls (low or very low quality evidence). The pain at 9 to 24 hours was generally reduced by about 0.5 cm (a modest reduction) on the visual analogue scale of 1 to 10 cm in the comparisons involving the different pharmacological agents and inactive controls (low or very low quality evidence). There is evidence of very low quality that different pharmacological agents including non-steroidal anti-inflammatory drugs, opioid analgesics, and anticonvulsant analgesics reduce pain scores in people at low anaesthetic risk undergoing elective laparoscopic cholecystectomy. However, the decision to use these drugs has to weigh the clinically small reduction in pain against uncertain evidence of serious adverse events associated with many of these agents. Further randomised clinical trials of low risk of systematic and random errors are necessary. Such trials should include important clinical outcomes such as quality of life and time to return to work in their assessment.
    Cochrane database of systematic reviews (Online) 03/2014; 3:CD008261. · 5.70 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: While laparoscopic cholecystectomy is generally considered less painful than open surgery, pain is one of the important reasons for delayed discharge after day surgery and overnight stay laparoscopic cholecystectomy. The safety and effectiveness of intraperitoneal local anaesthetic instillation in people undergoing laparoscopic cholecystectomy is unknown. To assess the benefits and harms of intraperitoneal instillation of local anaesthetic agents in people undergoing laparoscopic cholecystectomy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and Science Citation Index Expanded to March 2013 to identify randomised clinical trials of relevance to this review. We considered only randomised clinical trials (irrespective of language, blinding, or publication status) comparing local anaesthetic intraperitoneal instillation versus placebo, no intervention, or inactive control during laparoscopic cholecystectomy for the review with regards to benefits while we considered quasi-randomised studies and non-randomised studies for treatment-related harms. Two review authors collected the data independently. We analysed the data with both fixed-effect and random-effects models using Review Manager 5 analysis. For each outcome, we calculated the risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI). We included 58 trials, of which 48 trials with 2849 participants randomised to intraperitoneal local anaesthetic instillation (1558 participants) versus control (1291 participants) contributed data to one or more of the outcomes. All the trials except one trial with 30 participants were at high risk of bias. Most trials included only low anaesthetic risk people undergoing elective laparoscopic cholecystectomy. Various intraperitoneal local anaesthetic agents were used but bupivacaine in the liquid form was the most common local anaesthetic used. There were considerable differences in the methods of local anaesthetic instillation including the location (subdiaphragmatic, gallbladder bed, or both locations) and timing (before or after the removal of gallbladder) between the trials. There was no mortality in either group in the eight trials that reported mortality (0/236 (0%) in local anaesthetic instillation versus 0/210 (0%) in control group; very low quality evidence). One participant experienced the outcome of serious morbidity (eight trials; 446 participants; 1/236 (0.4%) in local anaesthetic instillation group versus 0/210 (0%) in the control group; RR 3.00; 95% CI 0.13 to 67.06; very low quality evidence). Although the remaining trials did not report the overall morbidity, three trials (190 participants) reported that there were no intra-operative complications. Twenty trials reported that there were no serious adverse events in any of the 715 participants who received local anaesthetic instillation. None of the trials reported participant quality of life, return to normal activity, or return to work.The effect of local anaesthetic instillation on the proportion of participants discharged as day surgery between the two groups was imprecise and compatible with benefit and no difference of intervention (three trials; 242 participants; 89/160 (adjusted proportion 61.0%) in local anaesthetic instillation group versus 40/82 (48.8%) in control group; RR 1.25; 95% CI 0.99 to 1.58; very low quality evidence). The MD in length of hospital stay was 0.04 days (95% CI -0.23 to 0.32; five trials; 335 participants; low quality evidence). The pain scores as measured by the visual analogue scale (VAS) were significantly lower in the local anaesthetic instillation group than the control group at four to eight hours (32 trials; 2020 participants; MD -0.99 cm; 95% CI -1.10 to -0.88 on a VAS scale of 0 to 10 cm; very low quality evidence) and at nine to 24 hours (29 trials; 1787 participants; MD -0.53 cm; 95% CI -0.62 to -0.44; very low quality evidence). Various subgroup analyses and meta-regressions to investigate the influence of the different local anaesthetic agents, different methods of local anaesthetic instillation, and different controls on the effectiveness of local anaesthetic intraperitoneal instillation were inconsistent. Serious adverse events were rare in studies evaluating local anaesthetic intraperitoneal instillation (very low quality evidence). There is very low quality evidence that it reduces pain in low anaesthetic risk people undergoing elective laparoscopic cholecystectomy. However, the clinical importance of this reduction in pain is unknown and likely to be small. Further randomised clinical trials of low risk of systematic and random errors are necessary. Such trials should include important clinical outcomes such as quality of life and time to return to work in their assessment.
    Cochrane database of systematic reviews (Online) 03/2014; 3:CD007337. · 5.70 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: While laparoscopic cholecystectomy is generally considered to be less painful than open surgery, pain is one of the important reasons for delayed discharge after day surgery resulting in overnight stay following laparoscopic cholecystectomy. The safety and effectiveness of local anaesthetic wound infiltration in people undergoing laparoscopic cholecystectomy is not known. To assess the benefits and harms of local anaesthetic wound infiltration in patients undergoing laparoscopic cholecystectomy and to identify the best method of local anaesthetic wound infiltration with regards to the type of local anaesthetic, dosage, and time of administration of the local anaesthetic. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and Science Citation Index Expanded until February 2013 to identify studies of relevance to this review. We included randomised clinical trials for benefit and quasi-randomised and comparative non-randomised studies for treatment-related harms. Only randomised clinical trials (irrespective of language, blinding, or publication status) comparing local anaesthetic wound infiltration versus placebo, no intervention, or inactive control during laparoscopic cholecystectomy, trials comparing different local anaesthetic agents for local anaesthetic wound infiltration, and trials comparing the different times of local anaesthetic wound infiltration were considered for the review. Two review authors collected the data independently. We analysed the data with both fixed-effect and random-effects meta-analysis models using RevMan. For each outcome, we calculated the risk ratio (RR) or mean difference (MD) with 95% confidence interval (CI). Twenty-six trials fulfilled the inclusion criteria of the review. All the 26 trials except one trial of 30 participants were at high risk of bias. Nineteen of the trials with 1263 randomised participants provided data for this review. Ten of the 19 trials compared local anaesthetic wound infiltration versus inactive control. One of the 19 trials compared local anaesthetic wound infiltration with two inactive controls, normal saline and no intervention. Two of the 19 trials had four arms comparing local anaesthetic wound infiltration with inactive controls in the presence and absence of co-interventions to decrease pain after laparoscopic cholecystectomy. Four of the 19 trials had three or more arms that could be included for the comparison of local anaesthetic wound infiltration versus inactive control and different methods of local anaesthetic wound infiltration. The remaining two trials compared different methods of local anaesthetic wound infiltration.Most trials included only low anaesthetic risk people undergoing elective laparoscopic cholecystectomy. Seventeen trials randomised a total of 1095 participants to local anaesthetic wound infiltration (587 participants) versus no local anaesthetic wound infiltration (508 participants). Various anaesthetic agents were used but bupivacaine was the commonest local anaesthetic used. There was no mortality in either group in the seven trials that reported mortality (0/280 (0%) in local anaesthetic infiltration group versus 0/259 (0%) in control group). The effect of local anaesthetic on the proportion of people who developed serious adverse events was imprecise and compatible with increase or no difference in serious adverse events (seven trials; 539 participants; 2/280 (0.8%) in local anaesthetic group versus 1/259 (0.4%) in control; RR 2.00; 95% CI 0.19 to 21.59; very low quality evidence). None of the serious adverse events were related to local anaesthetic wound infiltration. None of the trials reported patient quality of life. The proportion of participants who were discharged as day surgery patients was higher in the local anaesthetic infiltration group than in the no local anaesthetic infiltration group (one trial; 97 participants; 33/50 (66.0%) in the local anaesthetic group versus 20/47 (42.6%) in the control group; RR 1.55; 95% CI 1.05 to 2.28; very low quality evidence). The effect of local anaesthetic on the length of hospital stay was compatible with a decrease, increase, or no difference in the length of hospital stay between the two groups (four trials; 327 participants; MD -0.26 days; 95% CI -0.67 to 0.16; very low quality evidence). The pain scores as measured by the visual analogue scale (0 to 10 cm) were lower in the local anaesthetic infiltration group than the control group at 4 to 8 hours (13 trials; 806 participants; MD -1.33 cm on the VAS; 95% CI -1.54 to -1.12; very low quality evidence) and 9 to 24 hours (12 trials; 756 participants; MD -0.36 cm on the VAS; 95% CI -0.53 to -0.20; very low quality evidence). The effect of local anaesthetic on the time taken to return to normal activity between the two groups was imprecise and compatible with a decrease, increase, or no difference in the time taken to return to normal activity (two trials; 195 participants; MD 0.14 days; 95% CI -0.59 to 0.87; very low quality evidence). None of the trials reported on return to work.Four trials randomised a total of 149 participants to local anaesthetic wound infiltration prior to skin incision (74 participants) versus local anaesthetic wound infiltration at the end of surgery (75 participants). Two trials randomised a total of 176 participants to four different local anaesthetics (bupivacaine, levobupivacaine, ropivacaine, neosaxitoxin). Although there were differences between the groups in some outcomes the changes were not consistent. There was no evidence to support the preference of one local anaesthetic over another or to prefer administration of local anaesthetic at a specific time compared with another. Serious adverse events were rare in studies evaluating local anaesthetic wound infiltration (very low quality evidence). There is very low quality evidence that infiltration reduces pain in low anaesthetic risk people undergoing elective laparoscopic cholecystectomy. However, the clinical importance of this reduction in pain is likely to be small. Further randomised clinical trials at low risk of systematic and random errors are necessary. Such trials should include important clinical outcomes such as quality of life and time to return to work in their assessment.
    Cochrane database of systematic reviews (Online) 03/2014; 3:CD007049. · 5.70 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Surgical training has traditionally been one of apprenticeship, where the surgical trainee learns to perform surgery under the supervision of a trained surgeon. This is time consuming, costly, and of variable effectiveness. Training using a box model physical simulator is an option to supplement standard training. However, the value of this modality on trainees with limited prior laparoscopic experience is unknown. To compare the benefits and harms of box model training for surgical trainees with limited prior laparoscopic experience versus standard surgical training or supplementary animal model training. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and Science Citation Index Expanded to May 2013. We planned to include all randomised clinical trials comparing box model trainers versus other forms of training including standard laparoscopic training and supplementary animal model training in surgical trainees with limited prior laparoscopic experience. We also planned to include trials comparing different methods of box model training. Two authors independently identified trials and collected data. We analysed the data with both the fixed-effect and the random-effects models using Review Manager 5. For each outcome, we calculated the risk ratio (RR), mean difference (MD), or standardised mean difference (SMD) with 95% confidence intervals (CI) based on intention-to-treat analysis whenever possible. We identified eight trials that met the inclusion criteria. One trial including 17 surgical trainees did not contribute to the meta-analysis. We included seven trials (249 surgical trainees belonging to various postgraduate years ranging from year one to four) in which the participants were randomised to supplementary box model training (122 trainees) versus standard training (127 trainees). Only one trial (50 trainees) was at low risk of bias. The box trainers used in all the seven trials were video trainers. Six trials were conducted in USA and one trial in Canada. The surgeries in which the final assessments were made included laparoscopic total extraperitoneal hernia repairs, laparoscopic cholecystectomy, laparoscopic tubal ligation, laparoscopic partial salpingectomy, and laparoscopic bilateral mid-segment salpingectomy. The final assessments were made on a single operative procedure.There were no deaths in three trials (0/82 (0%) supplementary box model training versus 0/86 (0%) standard training; RR not estimable; very low quality evidence). The other trials did not report mortality. The estimated effect on serious adverse events was compatible with benefit and harm (three trials; 168 patients; 0/82 (0%) supplementary box model training versus 1/86 (1.1%) standard training; RR 0.36; 95% CI 0.02 to 8.43; very low quality evidence). None of the trials reported patient quality of life. The operating time was significantly shorter in the supplementary box model training group versus the standard training group (1 trial; 50 patients; MD -6.50 minutes; 95% CI -10.85 to -2.15). The proportion of patients who were discharged as day-surgery was significantly higher in the supplementary box model training group versus the standard training group (1 trial; 50 patients; 24/24 (100%) supplementary box model training versus 15/26 (57.7%) standard training; RR 1.71; 95% CI 1.23 to 2.37). None of the trials reported trainee satisfaction. The operating performance was significantly better in the supplementary box model training group versus the standard training group (seven trials; 249 trainees; SMD 0.84; 95% CI 0.57 to 1.10).None of the trials compared box model training versus animal model training or versus different methods of box model training. There is insufficient evidence to determine whether laparoscopic box model training reduces mortality or morbidity. There is very low quality evidence that it improves technical skills compared with standard surgical training in trainees with limited previous laparoscopic experience. It may also decrease operating time and increase the proportion of patients who were discharged as day-surgery in the first total extraperitoneal hernia repair after box model training. However, the duration of the benefit of box model training is unknown. Further well-designed trials of low risk of bias and random errors are necessary. Such trials should assess the long-term impact of box model training on clinical outcomes and compare box training with other forms of training.
    Cochrane database of systematic reviews (Online) 03/2014; 3:CD010478. · 5.70 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Generally, before being operated on, patients will be given informal information by the healthcare providers involved in the care of the patients (doctors, nurses, ward clerks, or healthcare assistants). This information can also be provided formally in different formats including written information, formal lectures, or audio-visual recorded information. To compare the benefits and harms of formal preoperative patient education for patients undergoing laparoscopic cholecystectomy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 2, 2013), MEDLINE, EMBASE, and Science Citation Index Expanded to March 2013. We included only randomised clinical trials irrespective of language and publication status. Two review authors independently extracted the data. We planned to calculate the risk ratio with 95% confidence intervals (CI) for dichotomous outcomes, and mean difference (MD) or standardised mean difference (SMD) with 95% CI for continuous outcomes based on intention-to-treat analyses when data were available. A total of 431 participants undergoing elective laparoscopic cholecystectomy were randomised to formal patient education (215 participants) versus standard care (216 participants) in four trials. The patient education included verbal education, multimedia DVD programme, computer-based multimedia programme, and PowerPoint presentation in the four trials. All the trials were of high risk of bias. One trial including 212 patients reported mortality. There was no mortality in either group in this trial. None of the trials reported surgery-related morbidity, quality of life, proportion of patients discharged as day-procedure laparoscopic cholecystectomy, the length of hospital stay, return to work, or the number of unplanned visits to the doctor. There were insufficient details to calculate the mean difference and 95% CI for the difference in pain scores at 9 to 24 hours (1 trial; 93 patients); and we did not identify clear evidence of an effect on patient knowledge (3 trials; 338 participants; SMD 0.19; 95% CI -0.02 to 0.41; very low quality evidence), patient satisfaction (2 trials; 305 patients; SMD 0.48; 95% CI -0.42 to 1.37; very low quality evidence), or patient anxiety (1 trial; 76 participants; SMD -0.37; 95% CI -0.82 to 0.09; very low quality evidence) between the two groups.A total of 173 participants undergoing elective laparoscopic cholecystectomy were randomised to electronic consent with repeat-back (patients repeating back the information provided) (92 participants) versus electronic consent without repeat-back (81 participants) in one trial of high risk of bias. The only outcome reported in this trial was patient knowledge. The effect on patient knowledge between the patient education with repeat-back versus patient education without repeat-back groups was imprecise and based on 1 trial of 173 participants; SMD 0.07; 95% CI -0.22 to 0.37; very low quality evidence). Due to the very low quality of the current evidence, the effects of formal patient education provided in addition to the standard information provided by doctors to patients compared with standard care remain uncertain. Further well-designed randomised clinical trials of low risk of bias are necessary.
    Cochrane database of systematic reviews (Online) 02/2014; 2:CD009933. · 5.70 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Pancreatic cancer is an aggressive cancer. Resection of the cancer is the only treatment with the potential to achieve long-term survival. However, a third of patients with pancreatic cancer have locally advanced cancer involving adjacent structures such as blood vessels which are not usually removed because of fear of increased complications after surgery. Such patients often receive palliative treatment. Resection of the pancreas along with the involved vessels is an alternative to palliative treatment for patients with locally advanced pancreatic cancer. To compare the benefits and harms of surgical resection versus palliative treatment in patients with locally advanced pancreatic cancer. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 12), MEDLINE, EMBASE, Science Citation Index Expanded, and trial registers until February 2014. We included randomised controlled trials comparing pancreatic resection versus palliative treatments for patients with locally advanced pancreatic cancer (irrespective of language or publication status). Two authors independently assessed trials for inclusion and independently extracted the data. We analysed the data with both the fixed-effect and random-effects models using Review Manager (RevMan). We calculated the hazard ratio (HR), risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI) based on an intention-to-treat analysis. We identified two trials comparing pancreatic resection versus other treatments for patients with locally advanced pancreatic cancer. Ninety eight patients were randomised to pancreatic resection (n = 47) or palliative treatment (n = 51) in the two trials included in this review. Both trials were at high risk of bias. Both trials included patients who had locally advanced pancreatic cancer which involved the serosa anteriorly or retroperitoneum posteriorly or involved the blood vessels. Such pancreatic cancers would be considered generally unresectable. One trial included patients with pancreatic cancer in different locations of the pancreas including the head, neck and body (n = 42). The patients allocated to the pancreatic resection group underwent partial pancreatic resection (pancreatoduodenectomy with lymph node clearance or distal pancreatic resection with lymph node clearance) in this trial; the control group received palliative treatment with chemoradiotherapy. In the other trial, only patients with cancer in the head or neck of the pancreas were included (n = 56). The patients allocated to the pancreatic resection group underwent en bloc total pancreatectomy with splenectomy and vascular reconstruction in this trial; the control group underwent palliative bypass surgery with chemoimmunotherapy. The pancreatic resection group had lower mortality than the palliative treatment group (HR 0.38; 95% CI 0.25 to 0.58, very low quality evidence). Both trials followed the survivors up to at least five years. There were no survivors at two years in the palliative treatment group in either trial. Approximately 40% of the patients who underwent pancreatic resection were alive in the pancreatic resection group at the end of three years. This difference in survival was statistically significant (RR 22.68; 95% CI 3.15 to 163.22). The difference persisted at five years of follow-up (RR 8.65; 95% CI 1.12 to 66.89). Neither trial reported severe adverse events but it is likely that a significant proportion of patients suffered from severe adverse events in both groups. The overall peri-operative mortality in the resection group in the two trials was 2.5%. None of the trials reported quality of life. The estimated difference in the length of total hospital stay (which included all admissions of the patient related to the treatment) between the two groups was imprecise (MD -23.00 days; 95% CI -59.05 to 13.05, very low quality evidence). The total treatment costs were significantly lower in the pancreatic resection group than the palliative treatment group (MD -10.70 thousand USD; 95% CI -14.11 to -7.29, very low quality evidence). There is very low quality evidence that pancreatic resection increases survival and decreases costs compared to palliative treatments for selected patients with locally advanced pancreatic cancer and venous involvement. When sufficient expertise is available, pancreatic resection could be considered for selected patients with locally advanced pancreatic cancer who are willing to accept the potentially increased morbidity associated with the procedure. Further randomised controlled trials are necessary to increase confidence in the estimate of effect and to assess the quality of life of patients and the cost-effectiveness of pancreatic resection versus palliative treatment for locally advanced pancreatic cancer.
    Cochrane database of systematic reviews (Online) 02/2014; 2:CD010244. · 5.70 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Traditionally, laparoscopic cholecystectomy is performed using two 10-mm ports and two 5-mm ports. Recently, a reduction in the number of ports has been suggested as a modification of the standard technique with a view to decreasing pain and improving cosmesis. The safety and effectiveness of using fewer-than-four ports has not yet been established. To assess the benefits (such as improvement in cosmesis and earlier return to activity) and harms (such as increased complications) of using fewer-than-four ports (fewer-than-four-ports laparoscopic cholecystectomy) versus four ports in people undergoing laparoscopic cholecystectomy for any reason (symptomatic gallstones, acalculous cholecystitis, gallbladder polyp, or any other condition). We searched the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 8, 2013), MEDLINE, EMBASE, Science Citation Index Expanded, and the World Health Organization International Clinical Trials Registry Platform portal to September 2013. We included all randomised clinical trials comparing fewer-than-four ports versus four ports, that is, with standard laparoscopic cholecystectomy that is performed with two ports of at least 10-mm incision and two ports of at least 5-mm incision. Two review authors independently identified the trials and extracted the data. We analysed the data using both the fixed-effect and the random-effects models. For each outcome, we calculated the risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI) based on intention-to-treat analysis, whenever possible. We found nine trials with 855 participants that randomised participants to fewer-than-four-ports laparoscopic cholecystectomy (n = 427) versus four-port laparoscopic cholecystectomy (n = 428). Most trials included low anaesthetic risk participants undergoing elective laparoscopic cholecystectomy. Seven of the nine trials used a single port laparoscopic cholecystectomy and the remaining two trials used three-port laparoscopic cholecystectomy as the experimental intervention. Only one trial including 70 participants had low risk of bias. Fewer-than-four-ports laparoscopic cholecystectomy could be completed successfully in more than 90% of participants in most trials. The remaining participants were mostly converted to four-port laparoscopic cholecystectomy but some participants had to undergo open cholecystectomy.There was no mortality in either group in the seven trials that reported mortality (318 participants in fewer-than-four-ports laparoscopic cholecystectomy group and 316 participants in four-port laparoscopic cholecystectomy group). The proportion of participants with serious adverse events was low in both treatment groups and the estimated RR was compatible with a reduction and substantial increased risk with the fewer-than-four-ports group (6/318 (1.9%)) and four-port laparoscopic cholecystectomy group (0/316 (0%)) (RR 3.93; 95% CI 0.86 to 18.04; 7 trials; 634 participants; very low quality evidence). The estimated difference in the quality of life (measured between 10 and 30 days) was imprecise (standardised mean difference (SMD) 0.18; 95% CI -0.05 to 0.42; 4 trials; 510 participants; very low quality evidence), as was the proportion of participants in whom the laparoscopic cholecystectomy had to be converted to open cholecystectomy between the groups (fewer-than-four ports 3/289 (adjusted proportion 1.2%) versus four port: 5/292 (1.7%); RR 0.68; 95% CI 0.19 to 2.35; 5 trials; 581 participants; very low quality evidence). The fewer-than-four-ports laparoscopic cholecystectomy took 14 minutes longer to complete (MD 14.44 minutes; 95% CI 5.95 to 22.93; 9 trials; 855 participants; very low quality evidence). There was no clear difference in hospital stay between the groups (MD -0.01 days; 95% CI -0.28 to 0.26; 6 trials; 731 participants) or in the proportion of participants discharged as day surgery (RR 0.92; 95% CI 0.70 to 1.22; 1 trial; 50 participants; very low quality evidence) between the two groups. The times taken to return to normal activity and work were shorter by two days in the fewer-than-four-ports group compared with four-port laparoscopic cholecystectomy (return to normal activity: MD -1.20 days; 95% CI -1.58 to -0.81; 2 trials; 325 participants; very low quality evidence; return to work: MD -2.00 days; 95% CI -3.31 to -0.69; 1 trial; 150 participants; very low quality evidence). There was no significant difference in cosmesis scores at 6 to 12 months between the two groups (SMD 0.37; 95% CI -0.10 to 0.84; 2 trials; 317 participants; very low quality evidence). There is very low quality evidence that is insufficient to determine whether there is any significant clinical benefit in using fewer-than-four-ports laparoscopic cholecystectomy compared with four-port laparoscopic cholecystectomy. The safety profile of using fewer-than-four ports is yet to be established and fewer-than-four-ports laparoscopic cholecystectomy should be reserved for well-designed randomised clinical trials.
    Cochrane database of systematic reviews (Online) 02/2014; 2:CD007109. · 5.70 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Most surgical procedures involve a cut in the skin, allowing the surgeon to gain access to the surgical site. Most surgical wounds are closed fully at the end of the procedure; this review focuses on these closed wounds. There are many ways to close the surgical incision, for example, using sutures (stitches), staples, tissue adhesives or tapes. Skin sutures can be continuous or interrupted. In general, continuous sutures are usually subcuticular and can be absorbable or non-absorbable, while interrupted sutures are usually non-absorbable and involve the full thickness of the skin - although some surgeons do use absorbable interrupted sutures. To compare the benefits and harms of continuous compared with interrupted skin closure techniques in participants undergoing non-obstetric surgery. In August 2013 we searched the following databases: Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid Embase; and EBSCO CINAHL. We included only randomised controlled trials (RCTs) that compared skin closure using continuous sutures with skin closure using interrupted sutures, irrespective of whether there were differences in the nature of the suture materials used in the two groups. We included all relevant RCTs in the analysis, irrespective of language of publication, publication status, publication year or sample size. Two review authors independently identified the trials and extracted data. We calculated the risk ratio (RR) with 95% confidence intervals (CI) for comparing binary outcomes between the groups, and calculated the mean difference (MD) with 95% CI for comparing continuous outcomes. We performed meta-analysis using a fixed-effect model and a random-effects model. We performed intention-to-treat analysis whenever possible. We included five RCTs with a total of 827 participants. Outcomes were available for 730 participants (384 participants randomised to continuous sutures and 346 participants to interrupted sutures). All the trials were of unclear or high risk of bias. The participants underwent abdominal or groin operations. The only outcomes reported in the trials were superficial surgical site infection, superficial wound dehiscence (breakdown) and length of hospital stay. Other important outcomes such as quality of life, long-term patient outcomes and use of healthcare resources were not reported in these trials.Overall, 6.5% (39/602 participants, four trials) developed superficial surgical site infections. There was no significant difference between the groups in the proportion of participants who developed superficial surgical site infections (RR 0.73; 95% CI 0.40 to 1.33). A total of 23 participants (23/625 (3.7%), four trials) developed superficial wound dehiscence. Twenty-two of the 23 participants belonged to the interrupted suture group.The proportion of participants who developed superficial wound dehiscence was statistically significantly lower in the continuous suture group compared to the interrupted suture group (RR 0.08; 95% CI 0.02 to 0.35). Most of these wound dehiscences were reported in two recent trials in which the continuous skin suture groups received absorbable subcuticular sutures while the interrupted skin suture groups received non-absorbable transcutaneous sutures. The non-absorbable sutures were removed seven to nine days after surgery in the interrupted sutures groups whilst sutures in the comparator groups were not removed, being absorbable. The continuous suture technique with absorbable suture does not require suture removal and provides support for the wound for a longer period of time. This may have contributed to the difference between the two groups in the proportion of participants who developed superficial wound dehiscence. There was no significant difference in the length of the hospital stay between the two groups (MD -1.40 days; 95% CI -7.14 to 4.34). Superficial wound dehiscence may be reduced by using continuous subcuticular sutures. However, there is uncertainty about this because of the quality of the evidence. Besides, the nature of the suture material used may have led to this observation, as the continuous suturing technique used suture material that did not need to be removed, whereas the comparator used interrupted (non-absorbable) sutures that did need to be removed. Differences in the methods of skin closure have the potential to affect patient outcomes and use of healthcare resources. Further well-designed trials at low risk of bias are necessary to determine which type of suturing is better.
    Cochrane database of systematic reviews (Online) 02/2014; 2:CD010365. · 5.70 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Day surgery involves admission of selected patients to hospital for a planned surgical procedure with the patients returning home on the same day. An anaesthetic regimen usually involves a combination of an anxiolytic, an induction agent, a maintenance agent, a method of maintaining the airway (laryngeal mask versus endotracheal intubation), and a muscle relaxant. The effect of anaesthesia may continue after the completion of surgery and can delay discharge. Various regimens of anaesthesia have been suggested for day-procedure laparoscopic cholecystectomy. To compare the benefits and harms of different anaesthetic regimens (risks of mortality and morbidity, measures of recovery after surgery) in patients undergoing day-procedure laparoscopic cholecystectomy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (Issue 10, 2013), MEDLINE (PubMed) (1987 to November 2013), EMBASE (OvidSP) (1987 to November 2013), Science Citation Index Expanded (ISI Web of Knowledge) (1987 to November 2013), LILACS (Virtual Health Library) (1987 to November 2013), metaRegister of Controlled Trials (http://www.controlled-trials.com/mrct/) (November 2013), World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) portal (November 2013), and ClinicalTrials.gov (November 2013). We included randomized clinical trials comparing different anaesthetic regimens during elective day-procedure laparoscopic cholecystectomy (irrespective of language or publication status). Two authors independently assessed trials for inclusion and independently extracted the data. We calculated the risk ratio, rate ratio or mean difference with 95% confidence intervals based on intention-to-treat or available data analysis. We included 11 trials involving 1069 participants at low anaesthetic risk. The sample size varied from 40 to 300 participants. We included 23 comparisons. All trials were at a high risk of bias. We were unable to perform a meta-analysis because there were no two trials involving the same comparison. Primary outcomes included perioperative mortality, serious morbidity and proportion of patients who were discharged on the same day. There were no perioperative deaths or serious adverse events in either group in the only trial that reported this information (0/60). There was no clear evidence of a difference in the proportion of patients who were discharged on the same day between any of the comparisons. Overall, 472/554 patients (85%) included in this review were discharged as day-procedure laparoscopic cholecystectomy patients. Secondary outcomes included hospital readmissions, health-related quality of life, pain, return to activity and return to work. There was no clear evidence of a difference in hospital readmissions within 30 days in the only comparison in which this outcome was reported. One readmission was reported in the 60 patients (2%) in whom this outcome was assessed. Quality of life was not reported in any of the trials. There was no clear evidence of a difference in the pain intensity, measured by a visual analogue scale, between comparators in the only trial which reported the pain intensity at between four and eight hours after surgery. Times to return to activity and return to work were not reported in any of the trials. There is currently insufficient evidence to conclude that one anaesthetic regimen for day-procedure laparoscopic cholecystectomy is to be preferred over another. However, the data are sparse (that is, there were few trials under each comparison and the trials had few participants) and further well designed randomized trials at low risk of bias and which are powered to measure differences in clinically important outcomes are necessary to determine the optimal anaesthetic regimen for day-procedure laparoscopic cholecystectomy, one of the commonest procedures performed in the western world.
    Cochrane database of systematic reviews (Online) 01/2014; 1:CD009784. · 5.70 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Most surgical procedures involve a cut in the skin that allows the surgeon to gain access to the surgical site. Most surgical wounds are closed fully at the end of the procedure, and this review focuses on these. The human body has multiple layers of tissues, and the skin is the outermost of these layers. The loose connective tissue just beneath the skin is called subcutaneous tissue, and this generally contains fat. There is uncertainty about closure of subcutaneous tissue after surgery: some surgeons advocate closure of subcutaneous tissue, as they consider this closes dead space and leads to a decrease in wound complications; others consider closure of subcutaneous tissue to be an unnecessary step that increases operating time and involves the use of additional suture material without offering any benefit. To compare the benefits (such as decreased wound-related complications) and consequences (such as increased operating time) of subcutaneous closure compared with no subcutaneous closure in participants undergoing non-caesarean surgical procedures. In August 2013 we searched the following databases: Cochrane Wounds Group Specialised Register (searched 29 August, 2013); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 7); Ovid MEDLINE (1946 to August Week 3 2013); Ovid MEDLINE (In-Process & Other Non-Indexed Citations August 28, 2013); Ovid EMBASE (1974 to 2013 Week 34); and EBSCO CINAHL (1982 to 23 August 2013). We did not restrict studies with respect to language, date of publication or study setting. We included only randomised controlled trials (RCTs) comparing subcutaneous closure with no subcutaneous closure irrespective of the nature of the suture material(s) or whether continuous or interrupted sutures were used. We included all RCTs in the analysis, regardless of language, publication status, publication year, or sample size. Two review authors independently identified the trials and extracted data. We calculated the risk ratio (RR) with 95% confidence intervals (CI) for comparing binary (dichotomous) outcomes between the groups and calculated the mean difference (MD) with 95% CI for continuous outcomes. We performed meta-analysis using the fixed-effect model and random-effects model. We performed intention-to-treat analysis whenever possible. Eight RCTs met the inclusion criteria. Six of the trials provided data for this review and all of these were at high risk of bias. Six trials randomised a total of 815 participants to subcutaneous closure (410 participants) or no subcutaneous closure (405 participants). Overall, 7.7% of participants (63/815 of participants) developed superficial surgical site infections and there was no clear evidence of a difference between the two intervention groups (RR 0.84; 95% CI 0.53 to 1.33; very low quality evidence). Only two trials reported superficial wound dehiscence, with 7.9% (17/215) of participants developing the problem. It is not clear whether the lack of reporting of this outcome in other trials was because it did not occur, or was not measured. There was no clear evidence of a between-group difference in the proportion of participants who developed superficial wound dehiscence in the trials that reported this outcome (RR 0.56; 95% CI 0.22 to 1.41; very low quality evidence). Only one trial reported deep wound dehiscence, which occurred in 8.3% (5/60) of participants. There was no clear evidence of a difference in the proportion of participants who developed deep wound dehiscence between the two groups (RR 0.25; 95% CI 0.03 to 2.11; very low quality evidence). Three trials reported the length of hospital stay and found no significant difference between groups (MD 0.10 days; 95% CI -0.45 to 0.64; very low quality evidence). We do not know whether this review reveals a lack of effect or lack of evidence of effect. The confidence intervals for these outcomes were wide, and significant benefits or harms from subcutaneous closure cannot be ruled out. In addition, none of the trials assessed the impact of subcutaneous closure on quality of life, long-term patient outcomes (the follow-up period in the trials varied between one week and two months after surgery) or financial implications to the healthcare provider. There is currently evidence of very low quality which is insufficient to support or refute subcutaneous closure after non-caesarean operations. The use of subcutaneous closure has the potential to affect patient outcomes and utilisation of healthcare resources. Further well-designed trials at low risk of bias are necessary.
    Cochrane database of systematic reviews (Online) 01/2014; 1:CD010425. · 5.70 Impact Factor
  • Source
    Journal of Hepatology 01/2014; · 9.86 Impact Factor
  • Article: Gallstones.
    Kurinchi S Gurusamy, Brian R Davidson
    BMJ (online) 01/2014; 348:g2669. · 17.22 Impact Factor
  • Kurinchi S Gurusamy, Brian R Davidson
    BMJ Clinical Research 01/2014; 348:g4125. · 14.09 Impact Factor
  • Source
    Annals of Medicine and Surgery. 01/2014; 3(2):49.
  • [Show abstract] [Hide abstract]
    ABSTRACT: Antiviral therapy for recurrent hepatitis C infection after liver transplantation is controversial due to unresolved balance between benefits and harms. To compare the therapeutic benefits and harms of different antiviral regimens in patients with hepatitis C re-infected grafts after liver transplantation. We searched the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 1, 2013), MEDLINE, EMBASE, and Science Citation Index Expanded to February 2013. We considered only randomised clinical trials (irrespective of language, blinding, or publication status) comparing various antiviral therapies (alone or in combination) in the treatment of hepatitis C virus recurrence in liver transplantation for the review. Two authors collected the data independently. We calculated the risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI) using the fixed-effect and the random-effects models based on available case-analysis. In the presence of only trials for a dichotomous outcome, we performed the Fisher's exact test. Overall, 17 trials with 736 patients met the inclusion criteria for this review. All trials had high risk of bias. Five hundred and one patients randomised in 11 trials provided information for various comparisons in this systematic review after excluding post-randomisation drop-outs and patients from trials that did not report any of the outcomes of interest for this review. The comparisons for which outcomes were available included pegylated (peg) interferon versus control; peg interferon plus ribavirin versus control; ribavirin plus peg interferon versus peg interferon; peg interferon (1.5 μg/kg/week) plus ribavirin versus peg interferon (0.5 μg/kg/week) plus ribavirin; amantadine plus peg interferon plus ribavirin versus peg interferon plus ribavirin; interferon versus control; interferon plus ribavirin versus control; ribavirin versus interferon; and ribavirin versus placebo. Long-term follow-up was not available in these trials. There were no significant differences in mortality, retransplantation, graft rejections requiring retransplantation or medical treatment, or fibrosis worsening between the groups in any of the comparisons in which these outcomes were reported. Quality of life and liver decompensation were not reported in any of the trials. There was a significantly higher proportion of participants who developed serious adverse events in the ribavirin plus peg interferon combination therapy group than in the peg interferon monotherapy group (1 trial; 56 participants; 17/28 (60.7%) in the intervention group versus 5/28 (17.9%) in the control group; RR 3.40; 95% CI 1.46 to 7.94). There was no significant difference in proportion of participants who developed serious adverse events or in the number of serious adverse events between the intervention and control groups in the other comparisons that reported serious adverse events. Considering the lack of clinical benefit, there is currently no evidence to recommend or refute antiviral treatment for recurrent liver graft infection with hepatitis C virus. Further randomised clinical trials with low risk of bias and low risk of random errors with adequate duration of follow-up are necessary.
    Cochrane database of systematic reviews (Online) 12/2013; 12:CD006803. · 5.70 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Surgical resection is the only potentially curative treatment for pancreatic and periampullary cancer. A considerable proportion of patients undergo unnecessary laparotomy because of underestimation of the extent of the cancer on computed tomography (CT) scanning. Laparoscopy can detect metastases not visualised on CT scanning, enabling better assessment of the spread of cancer (staging of cancer). There has been no systematic review or meta-analysis assessing the role of diagnostic laparoscopy in assessing the resectability with curative intent in patients with pancreatic and periampullary cancer. To determine the diagnostic accuracy of diagnostic laparoscopy performed as an add-on test to CT scanning in the assessment of curative resectability in pancreatic and periampullary cancer. We searched the Cochrane Register of Diagnostic Test Accuracy Studies, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE via PubMed, EMBASE via OvidSP (from inception to 13 September 2012), and Science Citation Index Expanded (from 1980 to 13 September 2012). We included diagnostic accuracy studies of diagnostic laparoscopy in patients with potentially resectable pancreatic and periampullary cancer on CT scan, where confirmation of liver or peritoneal involvement was by histopathological examination of suspicious (liver or peritoneal) lesions obtained at diagnostic laparoscopy or laparotomy. We accepted any criteria of resectability used in the studies. We included studies irrespective of language, publication status, or study design (prospective or retrospective). We excluded case-control studies. Two authors independently performed data extraction and quality assessment using the QUADAS-2 tool. The specificity of diagnostic laparoscopy in all studies was 1 because there were no false positives since laparoscopy and the reference standard are one and the same if histological examination after diagnostic laparoscopy is positive. Therefore, the sensitivities were meta-analysed using a univariate random-effects logistic regression model. The probability of unresectability in patients who had a negative laparoscopy (post-test probability for patients with a negative test result) was calculated using the median probability of unresectability (pre-test probability) from the included studies and the negative likelihood ratio derived from the model (specificity of 1 assumed). The difference between the pre-test and post-test probabilities gave the overall added value of diagnostic laparoscopy compared to the standard practice of CT scan staging alone. Fifteen studies with a total of 1015 patients were included in the meta-analysis. Only one study including 52 patients had a low risk of bias and low applicability concern in the patient selection domain. The median pre-test probability of unresectable disease after CT scanning across studies was 40.3% (that is 40 out of 100 patients who had resectable cancer after CT scan were found to have unresectable disease on laparotomy). The summary sensitivity of diagnostic laparoscopy was 68.7% (95% CI 54.3% to 80.2%). Assuming a pre-test probability of 40.3%, the post-test probability of unresectable disease for patients with a negative test result was 0.17 (95% CI 0.12 to 0.24). This indicates that if a patient is said to have resectable disease after diagnostic laparoscopy and CT scan, there is a 17% probability that their cancer will be unresectable compared to a 40% probability for those receiving CT alone.A subgroup analysis of patients with pancreatic cancer gave a summary sensitivity of 67.9% (95% CI 41.1% to 86.5%). The post-test probability of unresectable disease after being considered resectable on both CT and diagnostic laparoscopy was 18% compared to 40% for those receiving CT alone. Diagnostic laparoscopy may decrease the rate of unnecessary laparotomy in patients with pancreatic and periampullary cancer found to have resectable disease on CT scan. On average, using diagnostic laparoscopy with biopsy and histopathological confirmation of suspicious lesions prior to laparotomy would avoid 23 unnecessary laparotomies in 100 patients in whom resection of cancer with curative intent is planned.
    Cochrane database of systematic reviews (Online) 11/2013; 11:CD009323. · 5.70 Impact Factor

Publication Stats

5k Citations
1,616.08 Total Impact Points

Institutions

  • 2014
    • Gazi University
      Engüri, Ankara, Turkey
  • 2003–2014
    • University College London Hospitals NHS Foundation Trust
      • Department of Surgery
      Londinium, England, United Kingdom
  • 1999–2014
    • University College London
      • • Division of Surgery and Interventional Science
      • • Royal Free Hospital
      • • Department of Pathology
      Londinium, England, United Kingdom
  • 1994–2011
    • Royal Free London NHS Foundation Trust
      Londinium, England, United Kingdom
  • 2010
    • University of East Anglia
      Norwich, England, United Kingdom
  • 2009
    • Royal University Hospital
      Saskatoon, Saskatchewan, Canada
    • University of Ioannina
      • Division of Surgery
      Ioánnina, Ipeiros, Greece
  • 1996–2009
    • University of London
      Londinium, England, United Kingdom
  • 2008
    • Leeds Teaching Hospitals NHS Trust
      Leeds, England, United Kingdom
  • 2007
    • Oxford University Hospitals NHS Trust
      Oxford, England, United Kingdom
  • 2005
    • University of Leipzig
      Leipzig, Saxony, Germany
    • Federal University of Minas Gerais
      Cidade de Minas, Minas Gerais, Brazil
  • 1997
    • M. K. Haji Orphanage Hospital
      Malappuram, Kerala, India