Dataset Information

Prophylactic effect of retromuscular mesh placement during loop ileostomy closure on incisional hernia incidence-a multicentre randomised patient- and observer-blind trial (P.E.L.I.O.N trial).

ABSTRACT:

Background

Incisional hernia is a frequent complication following loop ileostomy reversal. Incisional hernias are associated with morbidity, loss of health-related quality of life and costs and warrant the investigation of prophylactic measures. Prophylactic mesh implantation at the time of surgical stoma reversal has shown to be a promising and safe method to prevent incisional hernias in this setting. However, the efficacy of this method has not yet been investigated in a large multicentre randomised-controlled trial (RCT) with adequate external validity. The P.E.L.I.O.N. trial will evaluate the efficacy of prophylactic mesh reinforcement after loop ileostomy closure in decreasing the rate of incisional hernia versus standard closure alone.

Methods

P.E.L.I.O.N. is a multicentre, patient- and observer-blind RCT. Patients undergoing loop ileostomy closure will undergo intraoperative 1:1 randomisation into either abdominal wall closure with a continuous slowly absorbable suture in small-stitch technique without mesh reinforcement (control group) or abdominal wall closure with an additional reinforcement with a retromuscular non-absorbable, macro-pore (pore size ≥ 1000 μm or effective porosity >0%) light-weight monofilament or mixed structure mesh. A total of 304 patients (152 per group) will need to be randomised in the study. Based on inclusion and exclusion criteria, 1,014 patients are expected to be screened for eligibility in order to recruit the necessary number of patients. The primary endpoint will be the frequency of incision hernias within 24 months according to the European Hernia Society definition. Secondary endpoints will be the frequency of surgical site occurrences (including surgical site infections, wound seromas and hematomas, and enterocutaneous fistulas), postoperative pain, the number of revision surgeries and health-related quality of life. Safety will be assessed by measuring postoperative complications ≥ grade 3 according to the Dindo-Clavien classification.

Discussion

Depending on the results of the P.E.L.I.O.N. trial, prophylactic mesh implantation could become the new standard for loop ileostomy reversal.

Trial registration

DRKS00027921, U1111-1273-4657.

SUBMITTER: Muller S

PROVIDER: S-EPMC9890770 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Publications

Prophylactic effect of retromuscular mesh placement during loop ileostomy closure on incisional hernia incidence-a multicentre randomised patient- and observer-blind trial (P.E.L.I.O.N trial).

Müller Sven S Weyhe Dirk D Herrle Florian F Horvath Philipp P Bachmann Robert R von Ehrlich-Treuenstätt Viktor V Heger Patrick P Nasir Nadir N Klose Christina C Ritz Alexander A Sander Anja A Grohmann Erich E Dörr-Harim Colette C Mihaljevic André L AL

Trials 20230201 1

<h4>Background</h4>Incisional hernia is a frequent complication following loop ileostomy reversal. Incisional hernias are associated with morbidity, loss of health-related quality of life and costs and warrant the investigation of prophylactic measures. Prophylactic mesh implantation at the time of surgical stoma reversal has shown to be a promising and safe method to prevent incisional hernias in this setting. However, the efficacy of this method has not yet been investigated in a large multice ...[more]

PMID: 36726155

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Project description:BackgroundClosure of an abdominal stoma, a common elective operation, is associated with frequent complications; one of the commonest and impactful is incisional hernia formation. We aimed to investigate whether biological mesh (collagen tissue matrix) can safely reduce the incidence of incisional hernias at the stoma closure site.MethodsIn this randomised controlled trial (ROCSS) done in 37 hospitals across three European countries (35 UK, one Denmark, one Netherlands), patients aged 18 years or older undergoing elective ileostomy or colostomy closure were randomly assigned using a computer-based algorithm in a 1:1 ratio to either biological mesh reinforcement or closure with sutures alone (control). Training in the novel technique was standardised across hospitals. Patients and outcome assessors were masked to treatment allocation. The primary outcome measure was occurrence of clinically detectable hernia 2 years after randomisation (intention to treat). A sample size of 790 patients was required to identify a 40% reduction (25% to 15%), with 90% power (15% drop-out rate). This study is registered with ClinicalTrials.gov, NCT02238964.FindingsBetween Nov 28, 2012, and Nov 11, 2015, of 1286 screened patients, 790 were randomly assigned. 394 (50%) patients were randomly assigned to mesh closure and 396 (50%) to standard closure. In the mesh group, 373 (95%) of 394 patients successfully received mesh and in the control group, three patients received mesh. The clinically detectable hernia rate, the primary outcome, at 2 years was 12% (39 of 323) in the mesh group and 20% (64 of 327) in the control group (adjusted relative risk [RR] 0·62, 95% CI 0·43-0·90; p=0·012). In 455 patients for whom 1 year postoperative CT scans were available, there was a lower radiologically defined hernia rate in mesh versus control groups (20 [9%] of 229 vs 47 [21%] of 226, adjusted RR 0·42, 95% CI 0·26-0·69; p<0·001). There was also a reduction in symptomatic hernia (16%, 52 of 329 vs 19%, 64 of 331; adjusted relative risk 0·83, 0·60-1·16; p=0·29) and surgical reintervention (12%, 42 of 344 vs 16%, 54 of 346: adjusted relative risk 0·78, 0·54-1·13; p=0·19) at 2 years, but this result did not reach statistical significance. No significant differences were seen in wound infection rate, seroma rate, quality of life, pain scores, or serious adverse events.InterpretationReinforcement of the abdominal wall with a biological mesh at the time of stoma closure reduced clinically detectable incisional hernia within 24 months of surgery and with an acceptable safety profile. The results of this study support the use of biological mesh in stoma closure site reinforcement to reduce the early formation of incisional hernias.FundingNational Institute for Health Research Research for Patient Benefit and Allergan.

Project description:ImportanceIncisional hernia is a frequent complication after open abdominal surgery. Prophylactic mesh implantation in the onlay or sublay position requires dissection of the abdominal wall, potentially leading to wound-associated complications.ObjectiveTo compare the incidence of incisional hernia among patients after prophylactic intraperitoneal mesh implantation with that among patients after standard abdominal closure.Design, setting, and participantsAn open-label randomized clinical trial was performed in 169 patients undergoing elective open abdominal surgery from January 1, 2011, to February 29, 2014. Follow-up examinations were performed 1 year and 3 years after surgery. The study was conducted at Bern University Hospital, Bern, Switzerland, a referral center that offers the whole spectrum of abdominal surgical interventions. Patients with 2 or more of the following risk factors were included: overweight or obesity, diagnosis of neoplastic disease, male sex, or history of previous laparotomy. Patients were randomly assigned to prophylactic intraperitoneal mesh implantation or standard abdominal closure. Data were analyzed in August 2017.InterventionsIntraperitoneal implantation of a polypropylene-polyvinylidene fluoride mesh with circumferential fixation.Main outcomes and measuresThe primary end point was the incidence of incisional hernia 3 years after surgery. Secondary end points included mesh-related complications.ResultsAfter the exclusion of 19 patients, 150 patients (81 in the control group and 69 in the mesh group; mean [SD] age, 64.2 [11.1] years; 102 [68.0%] male) were studied. The cumulative incidence of incisional hernia was significantly lower in the mesh group compared with the control group (5 of 69 [7.2%] vs 15 of 81 [18.5%], log-rank test P = .03). Abdominal pain was observed in significantly more patients in the mesh group compared with the control group at 6 weeks (34 of 52 [65%] vs 26 of 59 [44%], P = .04) but not at 12 and 36 months postoperatively. No difference in surgical site infections was observed, but time to complete wound healing of surgical site infection was significantly longer in patients with mesh implantation (median [interquartile range], 8 [6-24] weeks compared with 5 [1-9] weeks; P = .03). Trunk extension was significantly decreased after mesh implantation compared with the control group (mean [SD], 1.73 [0.97] cm vs 2.40 [1.23] cm, P = .009).Conclusions and relevanceIn patients at elevated risk for incisional hernia, prophylactic intraperitoneal mesh implantation reduces the incidence of hernia formation but with increased early postoperative pain and prolonged wound healing of surgical site infection.Trial registrationClinicalTrials.gov Identifier: NCT01203553.

Dataset Information

Prophylactic effect of retromuscular mesh placement during loop ileostomy closure on incisional hernia incidence-a multicentre randomised patient- and observer-blind trial (P.E.L.I.O.N trial).

Background

Methods

Discussion

Trial registration

Publications

Prophylactic effect of retromuscular mesh placement during loop ileostomy closure on incisional hernia incidence-a multicentre randomised patient- and observer-blind trial (P.E.L.I.O.N trial).

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