Gijsbert D. Musters

Laparoscopic peritoneal lavage or sigmoidectomy for perforated diverticulitis with purulent peritonitis : a multicentre, parallel-group, randomised, open-label trial

BACKGROUND Case series suggest that laparoscopic peritoneal lavage might be a promising alternative to sigmoidectomy in patients with perforated diverticulitis. We aimed to assess the superiority of laparoscopic lavage compared with sigmoidectomy in patients with purulent perforated diverticulitis, with respect to overall long-term morbidity and mortality. METHODS We did a multicentre, parallel-group, randomised, open-label trial in 34 teaching hospitals and eight academic hospitals in Belgium, Italy, and the Netherlands (the Ladies trial). The Ladies trial is split into two groups: the LOLA group comparing laparoscopic lavage with sigmoidectomy and the DIVA group comparing Hartmanns procedure with sigmoidectomy plus primary anastomosis. The DIVA section of this trial is still underway but here we report the results of the LOLA section. Patients with purulent perforated diverticulitis were enrolled for LOLA, excluding patients with faecal peritonitis, aged older than 85 years, with high-dose steroid use (≥20 mg daily), and haemodynamic instability. Patients were randomly assigned (2:1:1; stratified by age [<60 years vs ≥60 years]) using secure online computer randomisation to laparoscopic lavage, Hartmanns procedure, or primary anastomosis in a parallel design after diagnostic laparoscopy. Patients were analysed according to a modified intention-to-treat principle and were followed up after the index operation at least once in the outpatient setting and after sigmoidoscopy and stoma reversal, according to local protocols. The primary endpoint was a composite endpoint of major morbidity and mortality within 12 months. This trial is registered with ClinicalTrials.gov, number NCT01317485. FINDINGS Between July 1, 2010, and Feb 22, 2013, 90 patients were randomly assigned in the LOLA section of the Ladies trial when the study was terminated by the data and safety monitoring board because of an increased event rate in the lavage group. Two patients were excluded for protocol violations. The primary endpoint occurred in 30 (67%) of 45 patients in the lavage group and 25 (60%) of 42 patients in the sigmoidectomy group (odds ratio 1·28, 95% CI 0·54-3·03, p=0·58). By 12 months, four patients had died after lavage and six patients had died after sigmoidectomy (p=0·43). INTERPRETATION Laparoscopic lavage is not superior to sigmoidectomy for the treatment of purulent perforated diverticulitis. FUNDING Netherlands Organisation for Health Research and Development.

Early reconstruction of the leaking ileal pouch‐anal anastomosis: a novel solution to an old problem

The study aimed to determine the effectiveness and direct medical costs of early surgical closure of the anastomotic defect after a short course of Endo‐sponge® therapy of the presacral cavity, compared with conventional treatment in patients with anastomotic leakage after ileal pouch‐anal anastomosis (IPAA).

Iron therapy for the treatment of preoperative anaemia in patients with colorectal carcinoma: a systematic review.

Preoperative anaemia is associated with increased morbidity and mortality. The aim of this systematic review is to evaluate the efficacy of preoperative iron supplementation in the treatment of anaemia, and its effect on the postoperative recovery of patients undergoing surgery for colorectal carcinoma.

Randomised controlled trial of transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND Study)

Objective Non-randomised studies suggest that endoscopic mucosal resection (EMR) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM), but EMR might be more cost-effective and safer. This trial compares the clinical outcome and cost-effectiveness of TEM and EMR for large rectal adenomas. Design Patients with rectal adenomas ≥3 cm, without malignant features, were randomised (1:1) to EMR or TEM, allowing endoscopic removal of residual adenoma at 3 months. Unexpected malignancies were excluded postrandomisation. Primary outcomes were recurrence within 24 months (aiming to demonstrate non-inferiority of EMR, upper limit 10%) and the number of recurrence-free days alive and out of hospital. Results Two hundred and four patients were treated in 18 university and community hospitals. Twenty-seven (13%) had unexpected cancer and were excluded from further analysis. Overall recurrence rates were 15% after EMR and 11% after TEM; statistical non-inferiority was not reached. The numbers of recurrence-free days alive and out of hospital were similar (EMR 609±209, TEM 652±188, p=0.16). Complications occurred in 18% (EMR) versus 26% (TEM) (p=0.23), with major complications occurring in 1% (EMR) versus 8% (TEM) (p=0.064). Quality-adjusted life years were equal in both groups. EMR was approximately €3000 cheaper and therefore more cost-effective. Conclusion Under the statistical assumptions of this study, non-inferiority of EMR could not be demonstrated. However, EMR may have potential as the primary method of choice due to a tendency of lower complication rates and a better cost-effectiveness ratio. The high rate of unexpected cancers should be dealt with in further studies.

Biological Mesh Closure of the Pelvic Floor After Extralevator Abdominoperineal Resection for Rectal Cancer: A Multicenter Randomized Controlled Trial (the BIOPEX-study)

Objective: To determine the effect of biological mesh closure on perineal wound healing after extralevator abdominoperineal resection (eAPR). Background: Perineal wound complications frequently occur after eAPR with preoperative radiotherapy for rectal cancer. Cohort studies have suggested that biological mesh closure of the pelvic floor improves perineal wound healing. Methods: Patients were randomly assigned to primary closure (standard arm) or biological mesh closure (intervention arm). A non–cross-linked porcine acellular dermal mesh was sutured to the pelvic floor remnants in the intervention arm, followed by a layered closure of the ischioanal and subcutaneous fat and skin similar to the control intervention. The outcome of the randomization was concealed from the patient and perineal wound assessor. The primary endpoint was the rate of uncomplicated perineal wound healing defined as a Southampton wound score of less than 2 at 30 days postoperatively. Patients were followed for 1 year. Results: In total, 104 patients were randomly assigned to primary closure (n = 54; 1 dropouts) and biological mesh closure (n = 50; 2 dropouts). Uncomplicated perineal wound healing rate at 30 days was 66% (33/50; 3 not evaluable) after primary closure, which did not significantly differ from 63% (30/48) after biological mesh closure [relative risk 1.056; 95% confidence interval (CI) 0.7854–1.4197; P = 0.7177). Freedom from perineal hernia at 1 year was 73% (95% CI 60.93–85.07) versus 87% (95% CI 77.49–96.51), respectively (P = 0.0316). Conclusions: Perineal wound healing after eAPR with preoperative radiotherapy for rectal cancer was not improved when using a biological mesh. A significantly lower 1-year perineal hernia rate after biological mesh closure is a promising secondary finding that needs longer follow-up to determine its clinical relevance.

Randomized controlled multicentre study comparing biological mesh closure of the pelvic floor with primary perineal wound closure after extralevator abdominoperineal resection for rectal cancer (BIOPEX-study)

BackgroundPrimary perineal wound closure after conventional abdominoperineal resection (cAPR) for rectal cancer has been the standard of care for many years. Since the introduction of neo-adjuvant radiotherapy and the extralevator APR (eAPR), oncological outcome has been improved, but at the cost of increased rates of perineal wound healing problems and perineal hernia. This has progressively increased the use of biological meshes, although not supported by sufficient evidence. The aim of this study is to determine the effectiveness of pelvic floor reconstruction using a biological mesh after standardized eAPR with neo-adjuvant (chemo)radiotherapy compared to primary perineal wound closure.Methods/DesignIn this multicentre randomized controlled trial, patients with a clinical diagnosis of primary rectal cancer who are scheduled for eAPR after neo-adjuvant (chemo)radiotherapy will be considered eligible. Exclusion criteria are prior radiotherapy, sacral resection above S4/S5, allergy to pig products or polysorbate, collagen disorders, and severe systemic diseases affecting wound healing, except for diabetes. After informed consent, 104 patients will be randomized between standard care using primary wound closure of the perineum and the experimental arm consisting of suturing a biological mesh derived from porcine dermis in the pelvic floor defect, followed by perineal closure similar to the control arm. Patients will be followed for one year after the intervention and outcome assessors and patients will be blinded for the study treatment. The primary endpoint is the percentage of uncomplicated perineal wound healing, defined as a Southampton wound score of less than II on day 30. Secondary endpoints are hospital stay, incidence of perineal hernia, quality of life, and costs.DiscussionThe BIOPEX-study is the first randomized controlled multicentre study to determine the additive value of using a biological mesh for perineal wound closure after eAPR with neo-adjuvant radiotherapy compared to primary perineal wound closure with regard to perineal wound healing and the occurrence of perineal hernia.Trail registration numberNCT01927497 (Clinicaltrial.gov).

Endoscopic mucosal resection of large rectal adenomas in the era of centralization: Results of a multicenter collaboration

Background and objective Endoscopic mucosal resection (EMR) of large rectal adenomas is largely being centralized. We assessed the safety and effectiveness of EMR in the rectum in a collaboration of 15 Dutch hospitals. Methods Prospective, observational study of patients with rectal adenomas >3 cm, resected by piecemeal EMR. Endoscopic treatment of adenoma remnants at 3 months was considered part of the intervention strategy. Outcomes included recurrence after 6, 12 and 24 months and morbidity. Results Sixty-four patients (50% male, age 69 ± 11, 96% ASA 1/2) presented with 65 adenomas (diameter 46 ± 17 mm, distance ab ano 4.5 cm (IQR 1–8), 6% recurrent lesion). Sixty-two procedures (97%) were technically successful. Histopathology revealed invasive carcinoma in three patients (5%), who were excluded from effectiveness analyses. At 3 months’ follow-up, 10 patients showed adenoma remnants. Recurrence was diagnosed in 16 patients during follow-up (recurrence rate 25%). Fifteen of 64 patients (23%) experienced 17 postprocedural complications. Conclusion In a multicenter collaboration, EMR was feasible in 97% of patients. Recurrence and postprocedural morbidity rates were 25% and 23%. Our results demonstrate the outcomes of EMR in the absence of tertiary referral centers.

Intersphincteric completion proctectomy with omentoplasty for chronic presacral sinus after low anterior resection for rectal cancer.

This study aimed to determine the clinical outcome of salvage surgery without restoring continuity for symptomatic chronic presacral sinus after low anterior resection (LAR) for rectal cancer.

Comment on: Predictors of wound dehiscence and its impact on mortality after abdominoperineal resection: data from the National Surgical Quality Improvement Program. Rencuzogullari A, Gorgun E, Binboga S, Ozuner G, Kessler H, Abbas MA

We read with great interest the article by Rencuzogullari et al. [1] on predictors of wound dehiscence after abdominoperineal resection (APR) and its association with mortality. The authors used a national database containing a total of 5161 patients who underwent APR for rectal cancer (79.1%), inflammatory bowel disease (8.2%) and other diseases between 2005 and 2012. They describe an overall wound dehiscence rate of 2.7% (n = 141), consisting of both abdominal and perineal wounds. Predicting factors for wound dehiscence were older age (p = 0.013), smoking (p = 0.009), dyspnea (p = 0.043) and perineal wound closure with a musculocutaneous flap (p\ 0.001). Wound dehiscence was associated with an increased risk of readmission (p\ 0.001), reoperation (p\ 0.001) and an increased mortality within 30 days (odds ratio 2.7; p = 0.045). The authors used a composite endpoint of both abdominal wall dehiscence and perineal wound dehiscence. This makes interpretation of the data rather complicated and confusing. Perineal wound dehiscence significantly differs from abdominal wound dehiscence in several ways. For example, the perineal wound is often included in the radiation field in contrast to the abdominal wound. Laparoscopy almost eliminates the problem of abdominal wall dehiscence, while it does not affect perineal wound dehiscence. A rectus abdominis flap is intended to reduce the risk of perineal dehiscence, but increases the risk of abdominal wall dehiscence. It is therefore problematic to determine predictive factors of such a composite endpoint and to analyze its impact on short-term outcome parameters. Apparently, the ACS-NSQIP dataset does not specify wound dehiscence after APR. Remarkably, the incidence of this composite endpoint was only 2.7%, while perineal wound dehiscence has been reported to occur in up to 27% of patients after APR [2]. Since only 21.1% of the procedures were performed laparoscopically, one would expect a substantial percentage of abdominal wall dehiscence. It is therefore likely that wound complications are significantly underreported in this registry. Presumably only clinically significant wound dehiscence was reported, which explains the observed association with readmission and mortality. However, this probably does not reflect the whole group of patients experiencing a certain degree of wound dehiscence of either the abdominal or perineal wound. Perineal wound closure techniques after APR can greatly differ between hospitals [3]. It is not clear from the article for which indication a flap was used, and which type of flap was applied. A muscle flap is reported by the authors to be an independent predictor of wound dehiscence, while one would expect the opposite. However, without separating abdominal and perineal wounds and specifying the indication, this is a clinically meaningless analysis. In addition, the type of muscle flap used could greatly affect the wound dehiscence rate. A vertical rectus abdominis flap affects abdominal wall integrity while a gluteal flap does not [4]. The present data show the clinical significance of wound problems in general, but specific lessons for patients undergoing APR cannot be learned from this analysis because of a lack of relevant information. & P. J. Tanis P.J.Tanis@amc.nl