[Show abstract][Hide abstract] ABSTRACT: The objective of this study was to provide a descriptive analysis of registered clinical trials in surgical oncology at ClinicalTrials.gov.
Data was extracted from ClinicalTrials.gov using the following search engine criteria: "Cancer" as Condition, "Surgery OR Operation OR Resection" as Intervention, and Non-Industry sponsored. The search was limited to Canada and the United States and included trials registered from January 1, 2001 to January 1, 2011.
Of 9,961 oncology trials, 1,049 (10.5 %) included any type of surgical intervention. Of these trials, 125 (11.9 %, 1.3 % of all oncology trials) assessed a surgical variable, 773 (73.7 %) assessed adjuvant/neoadjuvant therapies, and 151 (14.4 %) were observational studies. Of the trials assessing adjuvant therapies, systemic treatment (362 trials, 46.8 %) and multimodal therapy (129 trials, 16.7 %) comprised a large focus. Of the 125 trials where surgery was the intervention, 59 trials (47.2 %) focused on surgical techniques or devices, 45 trials (36.0 %) studied invasive diagnostic methods, and 21 trials (16.8 %) evaluated surgery versus no surgery. The majority of the 125 trials were nonrandomized (72, 57.6 %).
The number of registered surgical oncology trials is small in comparison to oncology trials as a whole. Clinical trials specifically designed to assess surgical interventions are vastly outnumbered by trials focusing on adjuvant therapies. Randomized surgical oncology trials account for <1 % of all registered cancer trials. Barriers to the design and implementation of randomized trials in surgical oncology need to be clarified in order to facilitate higher-level evidence in surgical decision-making.
Annals of Surgical Oncology 06/2013; · 4.12 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: INTRODUCTION: Historically, a non-small-cell lung carcinoma diagnosis, without pathologic subclassification, provided sufficient information to guide therapy. Evidence now demonstrates that pathologic subtype classification is central in selecting optimal treatment. This review aimed to identify factors associated with a specific pathologic diagnosis. METHODS: All nonoperative cases of non-small-cell lung carcinoma (NSCLC) referred to the medical oncology divisions of the Ottawa Hospital Cancer Centre (2008) and Princess Margaret Hospital, Toronto (2007-2010) were identified. The charts were reviewed for demographics, diagnostic methods, and final diagnosis. Logistic regression was performed to identify variables associated with a specific diagnosis. RESULTS: Of 739 patient records analyzed, 377 (51%) were men, 299 (40%) were aged over 70 years, and 510 (69%) had an Eastern Cooperative Oncology Group performance status of 0-2. Three hundred and eighty five (52%) of patients were diagnosed in a tertiary academic center. The lung primary was sampled in 503 (68%) of patients. Computed tomography-guided biopsy (n = 370, 50%) and bronchoscopy (n = 179, 24%) were the most common techniques. Four hundred and seventy seven (65%) of biopsies were cytologic specimens alone, and immunohistochemistry was performed in 337 (46%) of cases. The most common diagnoses were adenocarcinoma (n = 338, 46%), NSCLC not otherwise specified (n = 254, 34%), and squamous cell carcinoma (n = 115, 16%). Overall, 456 (62%) of patients received a specific pathologic diagnosis. Factors significantly associated with attaining a specific pathologic diagnosis were diagnosis outside an academic center (adjusted odds ratios [OR] 2.1 [95% CI, 1.41-3.14]; P = .0003), histologic laboratory samples (adjusted OR 1.58 [95% CI, 1.003-2.49]; P = .049), and immunohistochemical testing (adjusted OR 1.82 [95% CI, 1.25-2.70], P = .0021). CONCLUSIONS: A significant minority of patients with NSCLC do not receive a specific pathologic diagnosis. In an era of individualized medicine, this may potentially impact optimal clinical management.
Clinical Lung Cancer 01/2013; · 2.04 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Soy and red clover isoflavones are controversial due to purported estrogenic activity and possible effects on breast cancer. We conducted a systematic review of soy and red clover for efficacy in improving menopausal symptoms in women with breast cancer, and for potential impact on risk of breast cancer incidence or recurrence.
We searched MEDLINE, Embase, the Cochrane Library, and AMED from inception to March 2013 for human interventional or observational data pertaining to the safety and efficacy of soy and red clover isoflavones in patients with or at risk of breast cancer.
Of 4179 records, we included a total of 131 articles: 40 RCTs, 11 uncontrolled trials, and 80 observational studies. Five RCTs reported on the efficacy of soy for hot flashes, showing no significant reductions in hot flashes compared to placebo. There is lack of evidence showing harm from use of soy with respect to risk of breast cancer or recurrence, based on long term observational data. Soy intake consistent with that of a traditional Japanese diet (2-3 servings daily, containing 25-50mg isoflavones) may be protective against breast cancer and recurrence. Human trials show that soy does not increase circulating estradiol or affect estrogen-responsive target tissues. Prospective data of soy use in women taking tamoxifen does not indicate increased risk of recurrence. Evidence on red clover is limited, however existing studies suggest that it may not possess breast cancer-promoting effects.
Soy consumption may be associated with reduced risk of breast cancer incidence, recurrence, and mortality. Soy does not have estrogenic effects in humans. Soy intake consistent with a traditional Japanese diet appears safe for breast cancer survivors. While there is no clear evidence of harm, better evidence confirming safety is required before use of high dose (≥100mg) isoflavones can be recommended for breast cancer patients.
PLoS ONE 01/2013; 8(11):e81968. · 3.73 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background
Many patients diagnosed with Stage IIIB (AJCC 6th Edition; T4 and/or N3, no pleural effusion) non-small cell lung cancer (NSCLC) are treated with curative intent, despite a low cure rate. Guidelines are required to help select patients for radical therapy, to spare those patients with little chance of cure the toxicities of aggressive treatment. We performed a retrospective analysis to investigate factors influencing outcomes in these patients.
From 2002-2009, all cases of stage IIIB NSCLC from our institution were identified. Patients treated with radical radiotherapy (minimum dose 50 Gy), with or without chemotherapy, were included. Charts were reviewed for patient demographics, baseline blood-work, tumour factors, treatment factors, and hospitalizations. The primary outcome was overall survival (OS), measured from time of diagnosis.
Of 238 patients identified, 184 eligible cases were reviewed. The median follow-up for all patients was 17.2 months (Range: 1.7-237.1 months). The median progression free survival (PFS) was 10.8 months (95% CI: 9.6-12.4 months). Median survival was 17.9 months, and OS was 68%, 42%, and 28% at 1, 2, and 3 years respectively. In multivariate analysis, female sex (HR 0.58, 95% CI 0.37-0.88, p=0.0013), ≤5% weight loss (HR 0.64, 95% CI 0.43-0.93, p=0.01), and absence of N3 disease (HR 0.64, 95% CI 0.42-0.96, p=0.03) were associated with significantly longer survival.
OS was significantly longer in women, in patients with ≤5% weight loss, and those without N3 disease. Good patient selection remains important in the radical treatment of stage IIIB NSCLC.
Clinical Lung Cancer 01/2013; · 2.04 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Controversy exists regarding the optimal technique of subscapularis tendon mobilization during shoulder arthroplasty. The purpose of the present randomized double-blind study was to compare two of these techniques-lesser tuberosity osteotomy and subscapularis peel-with regard to muscle strength and functional outcomes.
Patients undergoing shoulder arthroplasty were randomized to undergo either a lesser tuberosity osteotomy or a subscapularis peel. The primary outcome was subscapularis muscle strength as measured with an electronic handheld dynamometer at twenty-four months postoperatively. Secondary outcomes included the Western Ontario Osteoarthritis of the Shoulder Index and American Shoulder and Elbow Surgeons scores. A sample size calculation determined that eighty-six patients provided 90% power with a 0.79 effect size to detect a significant difference between groups.
Forty-three patients were allocated to subscapularis osteotomy, and forty-four patients were allocated to subscapularis peel. Eighty-three percent of the study cohort returned for the twenty-four-month follow-up. The primary outcome of subscapularis muscle strength at twenty-four months revealed no significant difference (p = 0.131) between the lesser tuberosity osteotomy group (mean [and standard deviation], 4.4 ± 2.9 kg) and the subscapularis peel group (mean, 5.5 ± 2.6 kg). Comparison of secondary outcomes, including the Western Ontario Osteoarthritis of the Shoulder Index and American Shoulder and Elbow Surgeons scores, demonstrated no significant differences between groups at any time point. Compared with baseline measures, mean subscapularis muscle strength, Western Ontario Osteoarthritis of the Shoulder Index score, and American Shoulder and Elbow Surgeons score all improved significantly in both groups at twenty-four months (p < 0.001).
No significant differences in the primary or secondary outcomes of function were identified between the lesser tuberosity osteotomy group and the subscapularis peel group. For the parameters investigated, this trial does not demonstrate any clear advantage of one subscapularis treatment technique over the other.
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
The Journal of Bone and Joint Surgery 12/2012; 94(24):2239-46. · 3.23 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Protocolized sedation and daily sedation interruption are 2 strategies to minimize sedation and reduce the duration of mechanical ventilation and intensive care unit (ICU) stay. We hypothesized that combining these strategies would augment the benefits.
To compare protocolized sedation with protocolized sedation plus daily sedation interruption in critically ill patients.
Randomized controlled trial of 430 critically ill, mechanically ventilated adults conducted in 16 tertiary care medical and surgical ICUs in Canada and the United States between January 2008 and July 2011.
Continuous opioid and/or benzodiazepine infusions and random allocation to protocolized sedation (n = 209) (control) or to protocolized sedation plus daily sedation interruption (n = 214). Using validated scales, nurses titrated infusions to achieve light sedation. For patients receiving daily interruption, nurses resumed infusions, if indicated, at half of previous doses. Patients were assessed for delirium and for readiness for unassisted breathing.
Time to successful extubation. Secondary outcomes included duration of stay, doses of sedatives and opioids, unintentional device removal, delirium, and nurse and respiratory therapist clinical workload (on a 10-point visual analog scale [VAS]).
Median time to successful extubation was 7 days in both the interruption and control groups (median [IQR], 7 [4-13] vs 7 [3-12]; interruption group hazard ratio, 1.08; 95% CI, 0.86-1.35; P = .52). Duration of ICU stay (median [IQR], 10 [5-17] days vs 10 [6-20] days; P = .36) and hospital stay (median [IQR], 20 [10-36] days vs 20 [10-48] days; P = .42) did not differ between the daily interruption and control groups, respectively. Daily interruption was associated with higher mean daily doses of midazolam (102 mg/d vs 82 mg/d; P = .04) and fentanyl (median [IQR], 550 [50-1850] vs 260 [0-1400]; P < .001) and more daily boluses of benzodiazepines (mean, 0.253 vs 0.177; P = .007) and opiates (mean, 2.18 vs 1.79; P < .001). Unintentional endotracheal tube removal occurred in 10 of 214 (4.7%) vs 12 of 207 patients (5.8%) in the interruption and control groups, respectively (relative risk, 0.82; 95% CI, 0.36-1.84; P = .64). Rates of delirium were not significantly different between groups (53.3% vs 54.1%; relative risk, 0.98; 95% CI, 0.82-1.17; P = .83). Nurse workload was greater in the interruption group (VAS score, 4.22 vs 3.80; mean difference, 0.41; 95% CI, 0.17-0.66; P = .001).
For mechanically ventilated adults managed with protocolized sedation, the addition of daily sedation interruption did not reduce the duration of mechanical ventilation or ICU stay.
clinicaltrials.gov Identifier: NCT00675363.
JAMA The Journal of the American Medical Association 11/2012; 308(19):1985-92. · 29.98 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: more quickly from mechani-cal ventilation, with lower risk of delirium, when clini-cians use specific strategies to reduce excessive sedation. 1-3 A nursing-implemented sedation titration proto-col that specifies clear targets for level of awareness is one approach to mini-mize sedation. 4 Daily interruption of sedative infusions may achieve the same goal if infusions are resumed only when necessary and at half the
Journal of the American Medical Association 10/2012;
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: Controversy exists regarding the optimal technique of subscapularis mobilization during shoulder arthroplasty. The purpose of this study was to compare healing rates and subscapularis fatty infiltration in patients undergoing a lesser tuberosity osteotomy (LTO) versus subscapularis peel for exposure during shoulder arthroplasty. MATERIALS AND METHODS: Eighty-seven patients, with a mean age of 67.8 ± 10.9 years, undergoing shoulder arthroplasty, were randomized to receive either an LTO (n = 43) or peel (n = 44). Computed tomography scans were conducted preoperatively and at 12 months postoperatively. Outcome variables included healing rates and subscapularis Goutallier fatty infiltration grade, as well as subscapularis strength and Western Ontario Osteoarthritis of the Shoulder Index and American Shoulder and Elbow Surgeons outcome scores. RESULTS: Computed tomography imaging was available in 91% (n = 79) of the cohort. The healing rates for the peel (100%) and for the LTO (95%) did not differ significantly (P = .493). Preoperatively, the mean fatty infiltration grade for the peel (mean, 0.53) was not significantly different (P = .925) from the LTO (mean, 0.54). Postoperatively, the Goutallier mean fatty infiltration grade for the peel (mean, 0.95) did not differ significantly (P = .803) from the LTO (mean, 0.9). A significant increase in subscapularis fatty infiltration grade occurred postoperatively from the preoperative status (peel, P = .003; LTO, P = .0002). No statistically significant associations were observed between postoperative fatty infiltration grades and subscapularis strength, Western Ontario Osteoarthritis of the Shoulder Index scores, or American Shoulder and Elbow Surgeons scores. DISCUSSION: No statistically significant differences were observed in the healing rates or subscapularis fatty infiltration grades between the peel and the LTO. This trial does not show any clear difference in radiologic and clinical outcomes of one subscapularis management technique over the other.
Journal of shoulder and elbow surgery / American Shoulder and Elbow Surgeons ... [et al.] 08/2012; · 1.93 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Controversy exists regarding the optimal technique for arthroscopic rotator cuff repair. The purpose of this multicenter, randomized, double-blind controlled study was to compare the functional outcomes and healing rates after use of single-row and double-row suture techniques for repair of the rotator cuff.
Ninety patients undergoing arthroscopic rotator cuff repair were randomized to receive either a single-row or a double-row repair. The primary objective was to compare the Western Ontario rotator cuff index (WORC) score at twenty-four months. Secondary objectives included comparison of the constant and american shoulder and elbow surgeons (ASES) scores and strength between groups. Anatomical outcomes were assessed with magnetic resonance imaging (MRI) or ultrasonography to determine the postoperative healing rates.
Baseline demographic data including age (p = 0.29), sex (p = 0.68), affected side (p = 0.39), and rotator cuff tear size (p = 0.28) did not differ between groups. The WORC score did not differ significantly between groups at any time point (p = 0.48 at baseline, p = 0.089 at three months, p = 0.52 at six months, p = 0.83 at twelve months, and p = 0.60 at twenty-four months). The WORC score at each postoperative time point was significantly better than the baseline value. The Constant score, ASES score, and strength did not differ significantly between groups at any time point. Logistic regression analysis demonstrated that a smaller initial tear size and double-row fixation were associated with higher healing rates.
No significant differences in functional or quality-of-life outcomes were identified between single-row and double-row fixation techniques. A smaller initial tear size and a double-row fixation technique were associated with higher healing rates as assessed with ultrasonography or MRI.
Therapeutic level I. See Instructions for Authors for a complete description of levels of evidence.
The Journal of Bone and Joint Surgery 07/2012; 94(14):1249-57. · 3.23 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Improved diagnostic algorithms for sputum smear-negative tuberculosis (SNTB) are needed to address the dramatic increase in SNTB in regions with high human immunodeficiency virus (HIV) prevalence.
To determine whether the addition of C-reactive protein (CRP) to a prediction model using simple clinical criteria improves the diagnosis of SNTB among mostly antiretroviral-naïve adult HIV TB suspects in an out-patient setting.
A multiple logistic regression model was derived from a database of 228 HIV patients to predict the risk of SNTB using data from a previous prospective study.
The derived model demonstrated that male sex, night sweats, fever, low body mass index and anemia increased the probability of having SNTB. CRP improved the accuracy of the model (without CRP, area under the curve [AUC] 0.75, 95%CI 0.68-0.81 vs. model with CRP, AUC 0.81, 95%CI 0.76-0.87, P = 0.0014) to predict SNTB. Using reclassification tables, CRP correctly reclassified 27.9% of the patients (net reclassification improvement, P = 0.0005) into higher or lower risk categories. The strongest effect was seen in the reclassification improvement among patients with no TB, which was 20.6% (P = 0.0023).
CRP improved the performance of the prediction model in the diagnosis of SNTB in HIV patients, and may play a role in ruling out SNTB in this population. Prospective validation of this model is needed.
The international journal of tuberculosis and lung disease: the official journal of the International Union against Tuberculosis and Lung Disease 06/2012; 16(9):1247-51. · 2.61 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Postintubation hemodynamic instability (PIHI) is a potentially life-threatening adverse event of emergent endotracheal intubation. The objectives of this study were to determine the incidence, risk factors, and impact on patient outcomes associated with PIHI in intubations performed in emergency medicine.
A structured chart audit was performed of all consecutive adult patients requiring emergent endotracheal intubations over a 16-month period at a tertiary care emergency department (ED). Data collection included medications, comorbidities, vital signs in the 30 minutes before and after intubation, hospital length of stay, and in-hospital mortality. PIHI was defined as a decrease in systolic blood pressure (SBP) to ≤ 90 mm Hg, a decrease in SBP of ≥ 20% from baseline, a decrease in mean arterial pressure to ≤ 65 mm Hg, or the initiation of any vasopressor medication at any time in the 30 minutes following intubation.
Overall, 218 patients intubated in the ED were identified, and 44% (96 of 218) developed PIHI. On multivariate analysis, increasing age (OR 1.03, 95% CI 1.01-1.05), chronic obstructive pulmonary disease (OR 3.00, CI 1.19-7.57), and pre-emergent endotracheal intubation hemodynamic instability (OR 2.52, 95% CI 1.27-4.99) were associated with the development of PIHI. The use of a neuromuscular blocking medication was associated with a decreased incidence of PIHI (OR 0.34, 95% CI 0.16-0.75).
Based on our data, postintubation hypotension occurs in a significant proportion of ED patients requiring emergent airway control. Further investigation is needed to confirm the factors we found to be associated with PIHI and to determine if PIHI is associated with increased morbidity and mortality.
Canadian Journal of Emergency Medicine 03/2012; 14(2):74-82. · 1.05 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Many patients with chronic obstructive pulmonary disease continue to experience significant functional limitation despite the use of both long-acting anticholinergic and beta-agonist inhalers. Theophylline is a widely available medication which may further improve lung function and exercise performance. Previous studies evaluating the effects of theophylline on exercise capacity in chronic obstructive pulmonary disease (COPD) have demonstrated heterogeneous results.
We performed a randomized placebo-controlled double-blind pilot study assessing the effects of theophylline on constant load exercise duration and lung function, involving 24 COPD patients already treated with long-acting inhaled beta-agonist and long-acting anti-cholinergic bronchodilator therapy.
Analyzable data was available in 10 of 12 subjects in the treatment arm and 11 of 12 subjects in the control arm. Theophylline was associated with a 26.1% (95% confidence interval [CI]: -17.3-69.5) improvement in exercise duration compared to placebo. Four of 10 treated patients demonstrated an improvement in exercise duration exceeding the minimum clinically important difference of 33%, compared to 1 of 11 controls (P = 0.15). Furthermore, peak ventilation was reduced by 11.1%, (95% CI: 0.77-21.5) which may suggest improvements in gas exchange. There were no significant observed differences in resting lung function nor measures of dyspnea between the two treatment groups.
Our study demonstrated a trend, but not a statistically significant improvement in exercise duration and a reduction in peak ventilation with theophylline. Based on the observed mean differences and standard deviations in this pilot study, a randomized controlled trial would require 45 subjects in each arm to detect a significant change in exercise duration.
[Show abstract][Hide abstract] ABSTRACT: Supplemental oxygen therapy has been shown to improve exercise performance in patients with chronic obstructive pulmonary disease (COPD). It is unknown whether the magnitude of this benefit would be affected by participation in a pulmonary rehabilitation program.
To compare the effects of supplemental oxygen on exercise capacity in nonhypoxemic COPD patients before and after participation in a pulmonary rehabilitation program.
Sixteen patients with COPD underwent two pairs of constant-load exercise tests before and after participation in a three-month outpatient pulmonary rehabilitation program. Each pair of exercise tests consisted of a test performed with room air and a second test performed with 50% supplemental oxygen, in random order. The primary outcome was the difference in exercise duration between tests performed with supplemental oxygen and with room air. This difference was compared before and after participation in a pulmonary rehabilitation program.
Supplemental oxygen therapy improved exercise duration by 75 s before participation in a pulmonary rehabilitation program and by 153 s following pulmonary rehabilitation. Rehabilitation alone improved exercise duration by 28 s, but rehabilitation appeared to augment the exercise benefits of supplemental oxygen therapy by a mean of 78 s (95% CI 11 s to 145 s; P = 0.03).
The effects of supplemental oxygen therapy were augmented after pulmonary rehabilitation. The improvement in exercise duration with supplemental oxygen following rehabilitation was greater than either supplemental oxygen or pulmonary rehabilitation alone.
Canadian respiratory journal: journal of the Canadian Thoracic Society 01/2010; 17(1):e14-9. · 1.29 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Laparoscopic surgery may become the standard of care for the treatment of colorectal disease. Little is known regarding North American patterns of practice or the limiting factors and strategies for adoption among surgeons.
We sent a 28-item questionnaire to all general surgeon members of the Royal College of Physicians and Surgeons of Canada. We derived descriptive and correlative information using chi(2), Wilcoxon rank sum and Student t tests and multivariate logistic regression.
The return rate was 55% (694/1266). A total of 67% (462/694; 95% confidence interval 63%-70%) of respondents perform colorectal surgery. Of these, 54% perform laparoscopic colorectal surgery. Multivariate logistic regression identified 5 factors related to performing laparoscopic colorectal surgery: fewer years in practice (p < 0.001), male sex (p = 0.015), practising in the province of Quebec (p = 0.005), university-hospital affiliation (p = 0.034) and minimally invasive surgery fellowship training (p = 0.023). Lack of adequate operating time and formal training were the main reasons cited by surgeons not offering laparoscopic colon resections. Most surgeons (67%) felt that site visits from a minimally invasive surgeon would represent the most effective training method for acquiring advanced laparoscopic skills.
About half of Canadian general surgeons offer laparoscopic colorectal resections. Recent graduation, male sex, practice location, university-hospital affiliation and minimally invasive surgery training are significant predictors for offering a laparoscopic approach. Lack of operative time and formal training are the main barriers to adoption of the technique. Site visits by trained laparoscopic surgeons is the preferred method of acquiring advanced skills.
Canadian journal of surgery. Journal canadien de chirurgie 12/2009; 52(6):455-62. · 1.63 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The purpose was to determine if the perioperative benefits associated with laparoscopic colectomies are maintained as operative time increases.
A retrospective review was performed of a database that was prospectively collected from April 1991 to May 2005. Since operative time distributions were different, patients were divided into three groups: laparoscopic right colectomy or ileocecal resection, sigmoid resection, and total abdominal colectomy. The following outcomes were assessed: intraoperative and postoperative complications, days to surgical diet, length of stay, 30-day mortality, and the presence of a learning curve.
Following exclusions, there were 231 right colon and ileocecal resections, 210 sigmoid colectomies, and 46 total abdominal colectomies. With increasing operative time in both right/ileocecal and sigmoid resections, logistic regression demonstrated no significant association between intraoperative and postoperative complications, days to surgical diet, or length of stay. Weight was significantly correlated with increasing operative time in the right/ileocecal and sigmoid resection groups. In the total abdominal colectomy group, significant relationships between increased operative time and postoperative complications (P = 0.04), days to surgical diet (P = 0.02), and hospital stay (P = 0.03) were found. An operative time cut-point was determined in the total abdominal colectomy group. Patients with operative times >270 minutes were more likely to have postoperative complications (P = 0.024), longer ileus (five vs. three median days to surgical diet, P = 0.003), and longer length of stay (seven vs. five days, P = 0.04). This increased risk remained significant after adjusting for weight and diagnosis. No significant learning curve was identified.
Increasing operative time does not appear to adversely affect perioperative outcomes in segmental colectomies. Total abdominal colectomies lasting more than 270 minutes were associated with increased postoperative complications, days to surgical diet, and length of stay.
Diseases of the Colon & Rectum 10/2009; 52(10):1746-52. · 3.34 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: This study aimed to define the management and risk factors for intraoperative complications (IOC) and conversion in laparoscopic colorectal surgery, and to assess whether surgeon experience influences intraoperative outcomes.
Consecutive patients undergoing laparoscopic colorectal procedures from 1991 to 2005 were analyzed from a longitudinal prospectively collected database. All patients referred to the four surgeons involved in this study were offered a minimally invasive approach. Patient characteristics, perioperative variables, and surgeon experience data were analyzed and compared.
A total of 991 consecutive laparoscopic colorectal procedures were studied. The majority of operations were performed for malignant disease (n=526, 53%), and most frequently consisted of segmental colonic resections (n=718, 72%). A total of 85 patients (8.6%) had an IOC. Patients experiencing an IOC had a significantly higher median body weight (75 versus 68 kg, p=0.0047) and had a higher proportion of previous abdominal surgery (31% versus 20%, p=0.029). Only 39% of patients suffering an IOC required conversion to open surgery. A total of 126 (13%) cases were converted to open surgery. On multivariable analysis, previous abdominal surgery [odds ratio (OR) 3.40, 95% confidence interval (CI) 1.39-8.35, p=0.0076] was independently associated with having an IOC and a conversion to open within the same procedure. With increasing experience, individual surgeons were found to operate on heavier patients (p=0.025), and on patients who had a higher rate of previous intra-abdominal surgery (p<0.0001). Despite these risk factors, the early and late experience demonstrated no significant difference in terms of IOCs (p=0.54) and conversion to open surgery (p=0.40).
The majority of IOCs can be managed laparoscopically. With increasing experience surgeons can perform laparoscopic colorectal surgery on a patient population with a greater proportion of previous abdominal surgery and a higher mean body weight without adversely affecting their rates of intraoperative complications or conversion.
[Show abstract][Hide abstract] ABSTRACT: The recent introduction of hand-assist devices in laparoscopic colorectal surgery has renewed interest in the influence of incision length. This study aimed to define the impact of extraction incision length on the postoperative outcomes of laparoscopic left-sided colon and rectal resections.
Consecutive patients undergoing laparoscopic left-sided colorectal resection from 1991 to 2007 were retrieved from a prospectively collected database. The association between incision length and patient characteristics, diagnosis, and perioperative outcomes were analyzed using logistic regression, Spearman correlation, Wilcoxon test, and chi-square test.
A total of 494 laparoscopic colorectal resections (left, sigmoid, anterior, and low anterior resections) were retrieved. Patients with conversions to open surgery (n = 59) and missing data (n = 53) were excluded. As a result, 382 cases were included in the study. A slight majority of the patients had malignant disease (n = 202, 53%). The median incision length was 5 cm (interquartile range, 4-6 cm). Increasing weight was positively correlated with incision length (p = 0.0001). Male patients had modestly larger mean incisions than female patients (5.5 vs. 5.0 cm; p = 0.0075). Age, previous surgery, diagnosis, days to resumption of normal diet, and days to discharge from hospital showed no significant relationship with incision length. No association was observed between the incision length and intraoperative or postoperative complications.
Patients undergoing laparoscopic colorectal surgery appear to achieve the same perioperative outcomes irrespective of their extraction incision lengths. To maintain the short-term benefits of laparoscopy, surgeons should consider pursuing a minimally invasive technique, even when a larger extraction incision will ultimately be required.
[Show abstract][Hide abstract] ABSTRACT: This study was designed to assess whether the exclusion criteria used in the Clinical Outcomes of Surgical Therapy and Colon Cancer Laparoscopic or Open Resection trials affected the generalizability of their findings.
A prospective database of consecutive laparoscopic resections performed for colon cancer was reviewed. Patients were categorized into two groups: inclusion group and exclusion group, based on the selection criteria used in the Clinical Outcomes of Surgical Therapy and Colon Cancer Laparoscopic or Open Resection trials. Baseline and perioperative data were analyzed by using t-tests, Wilcoxon's rank-sum, chi-squared, and Fisher's exact test. Kaplan-Meier survival curves, followed by adjustment for tumor nodes metastasis stage and age utilizing a Cox proportional hazard model, were performed.
The inclusion group had 221 patients and the exclusion group had 166 (median age and gender distribution were similar). The exclusion group had a higher conversion rate (23 vs. 11.3 percent; P=0.0023). There was no difference in intraoperative complications (9 percent for exclusion group vs. 8.6 percent for inclusion group; P=0.8), operative time (180 minutes for exclusion group vs.172 minutes for inclusion group; P=0.24), or postoperative complication rates (33.7 percent for exclusion group vs. 26 percent for inclusion group; P=0.13). No difference was detected in perioperative mortality rates, length of stay, days to diet as tolerated, and adjusted two-year survival.
No differences were found in outcomes between the two groups in terms of operative/postoperative complications, length of stay, perioperative mortality, and two-year survival. It seems that all patients with colon cancer can potentially benefit from a laparoscopic approach.
Diseases of the Colon & Rectum 03/2008; 51(2):173-80. · 3.34 Impact Factor