[Show abstract][Hide abstract] ABSTRACT: Gastroparesis is common in surgical patients and frequently leads to the need for enteral tube feeding. Nasoenteral feeding tubes are usually placed endoscopically by gastroenterologists, but this procedure is relatively cumbersome for patients and labor-intensive for hospital staff. Electromagnetic (EM) guided bedside placement of nasoenteral feeding tubes by nurses may reduce patient discomfort, workload and costs, but randomized studies are lacking, especially in surgical patients. We hypothesize that EM guided bedside placement of nasoenteral feeding tubes is at least as effective as endoscopic placement in surgical patients, at lower costs.
The CORE trial is an investigator-initiated, parallel-group, pragmatic, multicenter randomized controlled non-inferiority trial. A total of 154 patients admitted to gastrointestinal surgical wards in five hospitals, requiring nasoenteral feeding, will be randomly allocated to undergo EM guided or endoscopic nasoenteral feeding tube placement. Primary outcome is reinsertion of the feeding tube, defined as the insertion of an endoscope or tube in the nose/mouth and esophagus for (re)placement of the feeding tube (e.g. after failed initial placement or dislodgement or blockage of the tube). Secondary outcomes include patient-reported outcomes, costs and tube (placement) related complications.
The CORE trial is designed to generate evidence on the effectiveness of EM guided placement of nasoenteral feeding tubes in surgical patients and the impact on costs as compared to endoscopic placement. The trial potentially offers a strong argument for wider implementation of this technique as method of choice for placement of nasoenteral feeding tubes.
Dutch Trial Register: NTR4420 , date registered 5-feb-2014.
[Show abstract][Hide abstract] ABSTRACT: Purpose:
Parastomal hernia (PSH) is a common complication after colostomy formation. Recent studies indicate that mesh implantation during formation of a colostomy might prevent a PSH. To determine if placement of a retromuscular mesh at the colostomy site is a feasible, safe and effective procedure in preventing a parastomal hernia, we performed a multicentre randomized controlled trial in 11 large teaching hospitals and three university centres in The Netherlands.
Augmentation of the abdominal wall with a retromuscular light-weight polypropylene mesh (Parietene Light™, Covidien) around the trephine was compared with traditional colostomy formation. Patients undergoing elective open formation of a permanent end-colostomy were eligible. 150 patients were randomized between 2010 and 2012. Primary endpoint of the PREVENT trial is the incidence of parastomal hernia. Secondary endpoints are morbidity, pain, quality of life, mortality and cost-effectiveness. This article focussed on the early results of the PREVENT trial and, therefore, operation time, postoperative morbidity, pain, and quality of life were measured.
Outcomes represent results after 3 months of follow-up. A total of 150 patients were randomized. Mean operation time of the mesh group (N = 72) was significantly longer than in the control group (N = 78) (182.6 vs. 156.8 min; P = 0.018). Four (2.7 %) peristomal infections occurred of which one (1.4 %) in the mesh group. No infection of the mesh occurred. Most of the other infections were infections of the perineal wound, equally distributed over both groups. No statistical differences were discovered in stoma or mesh-related complications, fistula or stricture formation, pain, or quality of life.
During open and elective formation of an end-colostomy, primary placement of a retromuscular light-weight polypropylene mesh for prevention of a parastomal hernia is a safe and feasible procedure. The PREVENT trial is registered at: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2018 .
[Show abstract][Hide abstract] ABSTRACT: In patients with mild gallstone pancreatitis, cholecystectomy during the same hospital admission might reduce the risk of recurrent gallstone-related complications, compared with the more commonly used strategy of interval cholecystectomy. However, evidence to support same-admission cholecystectomy is poor, and concerns exist about an increased risk of cholecystectomy-related complications with this approach. In this study, we aimed to compare same-admission and interval cholecystectomy, with the hypothesis that same-admission cholecystectomy would reduce the risk of recurrent gallstone-related complications without increasing the difficulty of surgery.
The Lancet 09/2015; 386(10000):1261-1268. DOI:10.1016/S0140-6736(15)00274-3 · 45.22 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The minimally invasive esophagectomy (MIE) is widely being implemented for esophageal cancer in order to reduce morbidity and improve quality of life. Non-randomized studies investigating the mid-term quality of life after MIE show conflicting results at 1-year follow-up. Therefore, the aim of this study is to determine whether MIE has a continuing better mid-term 1-year quality of life than open esophagectomy (OE) indicating both a faster recovery and less procedure-related symptoms.
A one-year follow-up analysis of the quality of life was conducted for patients participating in the randomized trial in which MIE was compared with OE. Late complications as symptomatic stenosis of anastomosis are also reported.
Quality of life at 1 year was better in the MIE group than in the OE group for the physical component summary SF36 [50 (6; 48-53) versus 45 (9; 42-48) p .003]; global health C30 [79 (10; 76-83) versus 67 (21; 60-75) p .004]; and pain OES18 module [6 (9; 2-8) versus 16 (16; 10-22) p .001], respectively. Twenty six patients (44 %) in the MIE and 22 patients (39 %) in the OE group were diagnosed and treated for symptomatic stenosis of the anastomosis.
This first randomized trial shows that MIE is associated with a better mid-term one-year quality of life compared to OE.
World Journal of Surgery 06/2015; 39(8). DOI:10.1007/s00268-015-3100-y · 2.64 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background:
In recent years, conventional colorectal resection and its aftercare have increasingly become replaced by laparoscopic surgery and enhanced recovery after surgery (ERAS) pathways, respectively.
To ascertain whether combining laparoscopy and ERAS have additional value within colorectal surgery.
A systematic review with meta-analysis was performed with two primary research questions; does laparoscopy offer an advantage when all patients receive ERAS perioperative care and does ERAS offer advantages in a laparoscopically operated patient population. All randomised and controlled clinical trials were identified using MEDLINE, EMBASE and Cochrane databases.
Primary search resulted in 319 hits. After inclusion criteria were applied, three RCTs and six CCTs were included in the meta-analysis. For laparoscopically operated patients with/without ERAS, no differences in morbidity were found and postoperative hospital stay favoured ERAS (MD -2.34 [-3.77, -0.91], Z = 3.20, p = 0.001). When comparing laparoscopy and open surgery within ERAS, major morbidity was significantly reduced in the laparoscopic group (OR 0.42 [0.26, 0.66], Z = 3.73, p = 0.006). Other outcome parameters showed no differences. Quality of included studies was considered moderate to poor overall with small sample sizes.
When laparoscopy and ERAS are combined, major morbidity and hospital stay are reduced. The reduction in morbidity seems to be due to laparoscopy rather than ERAS, so laparoscopy by itself offers independent advantages beyond ERAS care. Quality of included studies was moderate to poor, so conclusions should be regarded with some reservations.
[Show abstract][Hide abstract] ABSTRACT: Purpose:
To assess long-term superiority in terms of chronic pain between prolene hernia system (PHS), mesh plug repair (MPR) and Lichtenstein (L) technique for inguinal hernia repair.
Eight years after randomizing three commonly used techniques for primary inguinal hernia repair, the outcome was evaluated with a questionnaire measuring pain on verbal descriptor and visual analogue scales, including limitations on daily life activities, sensory disturbances and recurrences. From previous results patients characteristics, operative details and short- and mid-term pain outcome were extracted.
270 out of 308 eligible patients (88%) completed the follow-up after median 7.6 years (range 6.9-9.2) after the inguinal hernia operation. No significant differences between the repair techniques were found for pain, sensory disturbances or recurrences. Overall, the hernia recurrence rate was 6.3%. In total 63 patients (23%) reported long-term pain of which one-fourth graded this moderate to severe. Pain was experienced at least weekly by 26 patients (10%) and limiting daily activities for 36 patients (13%). With regard to the previously reported pain at 3 and 15 months follow-up, 106 patients (39%) experience no pain at all. For 101 patients (37%), initial pain disappeared. 41 patients (15%) suffered persisting pain at all three measure moments. 22 patients (8%) reported pain at 8 years follow-up after an initial pain-free period.
Long-term outcome after randomizing PHS, MPR and L showed no clinically relevant differences in chronic pain and its consequences. Although chronic pain is diminishing over time it remains a serious complication and has sometimes an onset long after the inguinal repair.
[Show abstract][Hide abstract] ABSTRACT: Introduction
The best route of feeding for patients undergoing an oesophagectomy is unclear. Concerns exist that early oral intake would increase the incidence and severity of pneumonia and anastomotic leakage. However, in studies including patients after many other types of gastrointestinal surgery and in animal experiments, early oral intake has been shown to be beneficial and enhance recovery. Therefore, we aim to determine the feasibility of early oral intake after oesophagectomy.
Methods and analysis
This study is a feasibility trial in which 50 consecutive patients will start oral intake directly following oesophagectomy. Primary outcomes will be the frequency and severity of anastomotic leakage and (aspiration) pneumonia. Clinical parameters will be registered prospectively and nutritional requirements and intake will be assessed by a dietician. Surgical complications will be registered.
Ethics and dissemination
Approval for this study has been obtained from the Medical Ethical Committee of the Catharina Hospital Eindhoven and the study has been registered at the Dutch Trial Register, NTR4136. Results will be published and presented at international congresses.
We hypothesise that the oral route of feeding is safe and feasible following oesophagectomy, as has been shown previously for other types of gastrointestinal surgery. It is expected that early oral nutrition will result in enhanced recovery. Furthermore, complications related to artificial feeding, such as jejunostomy tube feeding, are believed to be reduced. However, (aspiration) pneumonia and anastomotic leakage are potential risks that are carefully monitored.
Trial registration number
BMJ Open 06/2014; 4(6):e004557. DOI:10.1136/bmjopen-2013-004557 · 2.27 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Esophageal resection is associated with a high incidence of postoperative pneumonia. Respiratory complications account for almost half of the readmissions to the critical care unit. Postoperative complications can result in prolonged hospital stay and consequently increase healthcare costs. In cardiac surgery a preoperative inspiratory muscle training program has shown to prevent postoperative pneumonia and reduce length of hospital stay. While in some surgical centers inspiratory muscle training is already used in the preoperative phase in patients undergoing esophageal resection, the added value of this intervention on the reduction of pulmonary complications has not yet been investigated in large surgical populations other than cardiac surgery in a randomized and controlled study design.Methods/design: The effect of a preoperative inspiratory muscle training program on the incidence of postoperative pneumonia in patients undergoing esophageal resection will be studied in a single blind multicenter randomized controlled trial (the PREPARE study). In total 248 patients (age >18 years) undergoing esophageal resection for esophageal cancer will be included in this study. They are randomized to either usual care or usual care with an additional inspiratory muscle training intervention according to a high-intensity protocol which is performed with a tapered flow resistive inspiratory loading device. Patients have to complete 30 dynamic inspiratory efforts twice daily for 7 days a week until surgery with a minimum of 2 weeks. The starting training load will be aimed to be 60% of maximal inspiratory pressure and will be increased based on the rate of perceived exertion.The main study endpoint is the incidence of postoperative pneumonia. Secondary objectives are to evaluate the effect of preoperative inspiratory muscle training on length of hospital stay, duration of mechanical ventilation, incidence of other postoperative (pulmonary) complications, quality of life, and on postoperative respiratory muscle function and lung function.
The PREPARE study is the first multicenter randomized controlled trial to evaluate the hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary complications in patients undergoing esophageal resection.Trial registration: NCT01893008.
[Show abstract][Hide abstract] ABSTRACT: Background:
Intrathoracic anastomosis after oesophagectomy has recently been associated with reduced functional morbidity compared to a cervical anastomosis.
From January 2011 until August 2012, all operable patients were scheduled to undergo minimally invasive oesophagectomy (MIE) with intrathoracic anastomosis. Patient characteristics, complications, morbidity and mortality were prospectively registered and analysed.
Forty-five patients underwent MIE with intrathoracic stapled end-to-side anastomosis. Major changes in operative technique were made 2 times due to non-satisfactory results, dividing the patients into 3 groups. One patient in group 1 died. The anastomotic leakage rate decreased from 44% in group 1 to 0% in groups 2 and 3 (p = 0.007). The pulmonary complication rate decreased from 67% in group 1 to 44% in group 2 (not significant, NS) and 22% in group 3 (p = 0.04). The median hospital stay decreased from 17 days in group 1 to 14 days in group 2 (NS) and 8 days in group 3 (p < 0.001). There were no stenoses, no dilatations and no patients with recurrent laryngeal nerve palsy.
The introduction of the intrathoracic anastomosis led to favourable functional results but was initially associated with considerable morbidity. RESULTS improved after changing operative techniques, but the learning curve may also be responsible.
Digestive surgery 04/2014; 31(2):95-103. DOI:10.1159/000358812 · 2.16 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Nitric oxide donors, such as isosorbide dinitrate ointment (ISDN), are considered as first choice agents in the treatment of chronic anal fissure. Injection with botulinum toxin A in the internal anal sphincter is often used as second-line therapy, although it may give better results and fewer side effects than nitric oxide donors. The aim of this randomized clinical trial was to investigate whether botulinum toxin A (Dysport(®) ) is more effective than ISDN in the primary treatment of chronic anal fissure.
In the period April 2005 until October 2009, 60 patients (32 male) with a median age of 42 (25-82) years were randomized to receive either ISDN 10 mg/mL (1%) (n=33) or injection with 60 units Dysport(®) (n=27). The primary endpoint was the percentage complete fissure healing after 8 weeks.
After a median of 9 weeks complete fissure healing was noted in 18 of 27 patients in the Dysport(®) group and in 11 of 33 patients in the ISDN group (p=0.010). Absolute improvement of pain scores after 9 weeks was similar in both groups (p=0.733). Patients treated with Dysport(®) had fewer side effects than patients treated with ISDN (p=0.028). Of the patients with a healed fissure, 28% of the Dysport(®) group and 50% of the ISDN group had a recurrence within one year (p=0.286; HR 2.08; 95% CI=0.54-7.97).
Dysport(®) is more effective with fewer side effects than ISDN ointment in the primary treatment of chronic anal fissure. The recurrence rates within one year in both treatment groups is high. This article is protected by copyright. All rights reserved.
[Show abstract][Hide abstract] ABSTRACT: Acute pancreatitis is a severe condition that requires early identification of patients at risk of developing potentially lethal complications. Current clinical scoring systems and biochemical parameters are insufficient. In this study, we aimed to assess whether early plasma Angiopoietin-2 (Ang-2) is associated with adverse outcomes in patients with predicted severe acute pancreatitis (SAP).
This analysis is a substudy of the PROPATRIA trial (probiotics vs placebo in patients with predicted SAP). The Ang-2 levels were measured prospectively in plasma in the first 5 days after admission in 115 patients.
Early Ang-2 levels were higher in patients who developed SAP: 6.4 vs 3.1 μg/L (p < 0.001) and also were higher in patients who developed multiorgan failure in the first week (p = 0.001) and after the first week (p = 0.049). Furthermore, high Ang-2 levels were associated with infectious complications in the first week (p < 0.001) and after the first week (p < 0.001). Finally, plasma Ang-2 was significantly higher in patients who died (p < 0.001) and in patients who developed bowel ischemia (p < 0.001). As a predictor of adverse outcomes, plasma Ang-2 was superior to a number of current scores, such as the APACHE II score, the Imrie score, C-reactive protein, lipopolysaccharide binding protein, and procalcitonin.
In the setting of this randomized controlled trial, early plasma Ang-2 was found to be an accurate predictor of SAP, multiorgan failure, and infectious complications. As a biomarker, it did outperform all of the investigated conventional predictors that are currently used in clinical practice.
Journal of the American College of Surgeons 01/2014; 218(1):26-32. DOI:10.1016/j.jamcollsurg.2013.09.021 · 5.12 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: High Frequency electrical Stimulation (HFS) of the skin induces enhanced brain responsiveness expressed as enhanced Event-Related Potential (ERP) N1 amplitude to stimuli applied to the surrounding unconditioned skin in healthy volunteers. The aim of the present study was to investigate whether this enhanced ERP N1 amplitude could be a potential marker for altered cortical sensory processing in patients with persistent pain after surgery.
Nineteen male patients; 9 with and 10 without persistent pain after inguinal hernia repair received HFS. Before, directly after and thirty minutes after HFS evoked potentials and the subjective pain intensity were measured in response to electric pain stimuli applied to the surrounding unconditioned skin.
The results show that, thirty minutes after HFS, the ERP N1 amplitude observed at the conditioned arm was statistically significantly larger than the amplitude at the control arm across all patients. No statistically significant differences were observed regarding ERP N1 amplitude between patients with and without persistent pain. However, thirty minutes after HFS we did observe statistically significant differences of P2 amplitude at the conditioned arm between the two groups. The P2 amplitude decreased in comparison to baseline in the group of patients with pain.
The ERP N1 effect, induced after HFS, was not different between patients with vs. without persistent pain. The decreasing P2 amplitude was not observed in the patients without pain and also not in the previous healthy volunteer study and thus might be a marker for altered cortical sensory processing in patients with persistent pain after surgery.
PLoS ONE 12/2013; 8(12):e82701. DOI:10.1371/journal.pone.0082701 · 3.23 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The impact of postoperative complications after Major Abdominal Surgery (MAS) is substantial, especially when socio-economical aspects are taken into account. This systematic review focuses on the effects of preoperative exercise therapy (PEXT) on physical fitness prior to MAS, length of hospital admission and postoperative complications in patients eligible for MAS, and on what is known about the most effective kind of exercise regime.
A systematic search identified randomised controlled trials on exercise therapy and pulmonary physiotherapy prior to MAS. The methodological quality of the included studies was rated using the 'Delphi List For Quality Assessment of Randomised Clinical Trials'. The level of agreement between the two reviewers was estimated with Cohen's kappa.
A total of 6 studies were included, whose methodological quality ranged from moderate to good. Cohen's kappa was 0.90. Three studies reported on improving physical fitness prior to MAS with the aid of PEXT. Two studies reported on the effect of training on postoperative complications, showing contradictory results. Three studies focused on the effect of preoperative chest physiotherapy on postoperative lung function parameters after MAS. While the effects seem positive, the optimal training regime is still unclear.
Preoperative exercise therapy might be effective in improving the physical fitness of patients prior to major abdominal surgery, and preoperative chest physiotherapy seems effective in reducing pulmonary complications. However consensus on training method is lacking. Future research should focus on the method and effect of PEXT before high-risk surgical procedures.
International Journal of Surgery (London, England) 12/2013; 12(2). DOI:10.1016/j.ijsu.2013.11.018 · 1.53 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Infected necrotising pancreatitis is a potentially lethal disease that nearly always requires intervention. Traditionally, primary open necrosectomy has been the treatment of choice. In recent years, the surgical step-up approach, consisting of percutaneous catheter drainage followed, if necessary, by (minimally invasive) surgical necrosectomy has become the standard of care. A promising minimally invasive alternative is the endoscopic transluminal step-up approach. This approach consists of endoscopic transluminal drainage followed, if necessary, by endoscopic transluminal necrosectomy. We hypothesise that the less invasive endoscopic step-up approach is superior to the surgical step-up approach in terms of clinical and economic outcomes.Methods/design: The TENSION trial is a randomised controlled, parallel-group superiority multicenter trial. Patients with (suspected) infected necrotising pancreatitis with an indication for intervention and in whom both treatment modalities are deemed possible, will be randomised to either an endoscopic transluminal or a surgical step-up approach. During a 4 year study period, 98 patients will be enrolled from 24 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite of death and major complications within 6 months following randomisation. Secondary endpoints include complications such as pancreaticocutaneous fistula, exocrine or endocrine pancreatic insufficiency, need for additional radiological, endoscopic or surgical intervention, the need for necrosectomy after drainage, the number of (re-)interventions, quality of life, and total direct and indirect costs.
The TENSION trial will answer the question whether an endoscopic step-up approach reduces the combined primary endpoint of death and major complications, as well as hospital stay and related costs compared with a surgical step-up approach in patients with infected necrotising pancreatitis.
[Show abstract][Hide abstract] ABSTRACT: Background
Parastomal hernia is a common complication of a colostomy. Ultimately, one-third of patients with a parastomal hernia will need surgical correction due to frequent leakage or life-threatening bowel obstruction or strangulation. However, treatment remains a challenge resulting in high recurrence rates. Two single center trials demonstrated that the frequency of parastomal hernias decreases by prophylactic placement of a mesh around the stoma at the time of formation. Unfortunately, both studies were small-sized, single-center studies and with these small numbers less common complications could be missed which were the reasons to initiate a prospective randomized multicenter trial to determine if a retromuscular, preperitoneal mesh at the stoma site prevents parastomal hernia and does not cause unacceptable complications.
One hundred and fifty patients undergoing open procedure, elective formation of a permanent end-colostomy will be randomized into two groups. In the intervention group an end-colostomy is created with placement of a preperitioneal, retromuscular lightweight monofilament polypropylene mesh, and compared to a group with a traditional stoma without mesh. Patients will be recruited from 14 teaching hospitals in the Netherlands during a 2-year period. Primary endpoint is the incidence of parastomal hernia. Secondary endpoints are stoma complications, cost-effectiveness, and quality of life. Follow-up will be performed at 3 weeks, 3 months and at 1, 2, and 5 years. To find a difference of 20% with a power of 90%, a total number of 134 patients must be included. All results will be reported according to the CONSORT 2010 statement.
The PREVENT-trial is a multicenter randomized controlled trial powered to determine whether prophylactic placement of a polypropylene mesh decreases the incidence of a parastomal hernia versus the traditional stoma formation without a mesh.
The PREVENT-trial is registered at: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2018
[Show abstract][Hide abstract] ABSTRACT: Background:
After an initial attack of biliary pancreatitis, cholecystectomy minimizes the risk of recurrent biliary pancreatitis and other gallstone-related complications. Guidelines advocate performing cholecystectomy within 2 to 4 weeks after discharge for mild biliary pancreatitis. During this waiting period, the patient is at risk of recurrent biliary events. In current clinical practice, surgeons usually postpone cholecystectomy for 6 weeks due to a perceived risk of a more difficult dissection in the early days following pancreatitis and for logistical reasons. We hypothesize that early laparoscopic cholecystectomy minimizes the risk of recurrent biliary pancreatitis or other complications of gallstone disease in patients with mild biliary pancreatitis without increasing the difficulty of dissection and the surgical complication rate compared with interval laparoscopic cholecystectomy.
PONCHO is a randomized controlled, parallel-group, assessor-blinded, superiority multicenter trial. Patients are randomly allocated to undergo early laparoscopic cholecystectomy, within 72 hours after randomization, or interval laparoscopic cholecystectomy, 25 to 30 days after randomization. During a 30-month period, 266 patients will be enrolled from 18 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite endpoint of mortality and acute re-admissions for biliary events (that is, recurrent biliary pancreatitis, acute cholecystitis, symptomatic/obstructive choledocholithiasis requiring endoscopic retrograde cholangiopancreaticography including cholangitis (with/without endoscopic sphincterotomy), and uncomplicated biliary colics) occurring within 6 months following randomization. Secondary endpoints include the individual endpoints of the composite endpoint, surgical and other complications, technical difficulty of cholecystectomy and costs.
The PONCHO trial is designed to show that early laparoscopic cholecystectomy (within 72 hours) reduces the combined endpoint of mortality and re-admissions for biliary events as compared with interval laparoscopic cholecystectomy (between 25 and 30 days) after recovery of a first episode of mild biliary pancreatitis.
Current Controlled Trials: ISRCTN72764151.