Dataset Information

Randomised-controlled feasibility trial on abdominal wall closure techniques in patients undergoing relaparotomy (ReLap study; DRKS00013001).

ABSTRACT:

Background

Patients undergoing relaparotomy are generally underrepresented in clinical trials, despite how common the procedure is in clinical practice. Specifically, techniques for re-do abdominal wall closure have never been evaluated in a randomised-controlled trial. The aim of this trial was to identify the optimal abdominal wall closure technique in patients undergoing relaparotomy.

Methods

In this monocentric, randomised feasibility trial, patients scheduled for elective relaparotomy were randomised to abdominal wall closure with either the small stitches technique, using Monomax® 2-0, or the large stitches technique, using PDS II® 1 loop. Patients' postoperative courses were followed for 1 year after the index operation. Effectiveness and safety outcomes were compared at a level of significance of 5% between the two techniques.

Results

A total of 100 out of 131 patients (76.3%) were evenly randomised to the small stitches and large stitches groups. The time for abdominal wall closure did not differ between the two techniques (small stitches 27.5 ± 9.5 min versus large stitches 25.3 ± 12.4 min; p = 0.334). The overall comprehensive complication index was 14.4 ± 15.5 in the small stitches group and 19.9 ± 23.4 in the large stitches group (p = 0.168). Specifically, rates of surgical site infection (small stitches 30.0% versus large stitches 36.0%; p = 0.524) and burst abdomen (small stitches 4.0% versus large stitches 0.0%; p = 0.495) did not differ. After 1 year, incisional hernia rate was 7.5% in the small stitches group and 10.0% in the large stitches group (p > 0.999).

Discussion

Both abdominal wall closure techniques investigated in this trial were feasible in relaparotomy patients. This exploratory trial revealed no noticeable difference in the effectiveness or safety of the small stitches technique with Monomax® 2-0 versus the large stitches technique with PDS II® 1 loop. Therefore, surgeons should stay with their preferred suture technique in relaparotomy patients.

Trial registration

Deutsches Register Klinischer Studien ( www.germanctr.de ): DRKS00013001.

SUBMITTER: Probst P

PROVIDER: S-EPMC7359135 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Randomised-controlled feasibility trial on abdominal wall closure techniques in patients undergoing relaparotomy (ReLap study; DRKS00013001).

Probst Pascal P Tran Dinh Thien-An DT Hüttner Felix J FJ Harnoss Julian C JC Heger Patrick P Ritter Alina S AS Doerr-Harim Colette C Mihaljevic André L AL Knebel Phillip P Schneider Martin M Büchler Markus W MW Diener Markus K MK

Langenbeck's archives of surgery 20200606 4

<h4>Background</h4>Patients undergoing relaparotomy are generally underrepresented in clinical trials, despite how common the procedure is in clinical practice. Specifically, techniques for re-do abdominal wall closure have never been evaluated in a randomised-controlled trial. The aim of this trial was to identify the optimal abdominal wall closure technique in patients undergoing relaparotomy.<h4>Methods</h4>In this monocentric, randomised feasibility trial, patients scheduled for elective rel ...[more]

PMID: 32504207

Similar Datasets

Project description:ObjectivesIncisional hernias are common complications of midline abdominal closure. The 'Hughes Repair' combines a standard mass closure with a series of horizontal and two vertical mattress sutures within a single suture. There is evidence to suggest this technique is as effective as mesh repair for the operative management of incisional hernias; however, no trials have compared Hughes repair with standard mass closure for the prevention of incisional hernia formation. This paper aims to test the feasibility of running a randomised controlled trial of a comparison of abdominal wall closure methods following midline incisional surgery for colorectal cancer, in preparation to a definitive randomised controlled trial.Design and settingA feasibility trial (with 1:1 randomisation) conducted perioperatively during colorectal cancer surgery.ParticipantsPatients undergoing midline incisional surgery for resection of colorectal cancer.InterventionsComparison of two suture techniques (Hughes repair or standard mass closure) for the closure of the midline abdominal wound following surgery for colorectal cancer.Primary and secondary outcomesA 30-patient feasibility trial assessed recruitment, randomisation, deliverability and early safety of the surgical techniques used.ResultsA total of 30 patients were randomised from 43 patients recruited and consented, over a 5-month period. 14 and 16 patients were randomised to arms A and B, respectively. There was one superficial surgical site infection (SSI) and two organ space SSIs reported in arm A, and two superficial SSIs and one complete wound dehiscence in arm B. There were no suspected unexpected serious adverse reactions reported in either arm. Independent data monitoring committee found no early safety concerns.ConclusionsThe feasibility trial found no early safety concerns and demonstrated that the trial was acceptable to patients. Progression to the pilot and main phases of the trial has now commenced following approval by the independent data monitoring committee.Trial registration numberISRCTN 25616490.

Project description:Incisional hernias are common complications of midline closure following abdominal surgery and cause significant morbidity, impaired quality of life and increased health care costs. The 'Hughes Repair' combines a standard mass closure with a series of horizontal and two vertical mattress sutures within a single suture. This theoretically distributes the load along the incision length as well as across it. There is evidence to suggest that this technique is as effective as mesh repair for the operative management of incisional hernias; however, no trials have compared the Hughes Repair with standard mass closure for the prevention of incisional hernia formation following a midline incision.This is a 1:1 randomised controlled trial comparing two suture techniques for the closure of the midline abdominal wound following surgery for colorectal cancer. Full ethical approval has been gained (Wales REC 3, MREC 12/WA/0374). Eight hundred patients will be randomised from approximately 20 general surgical units within the United Kingdom. Patients undergoing open or laparoscopic (more than a 5-cm midline incision) surgery for colorectal cancer, elective or emergency, are eligible. Patients under the age of 18 years, those having mesh inserted or undergoing musculofascial flap closure of the perineal defect in abdominoperineal wound closure, and those unable to give informed consent will be excluded. Patients will be randomised intraoperatively to either the Hughes Repair or standard mass closure. The primary outcome measure is the incidence of incisional hernias at 1 year as assessed by standardised clinical examination. The secondary outcomes include quality of life patient-reported outcome measures, cost-utility analysis, incidence of complete abdominal wound dehiscence and C-POSSUM scores. The incidence of incisional hernia at 1 year, assessed by computerised tomography, will form a tertiary outcome.A feasibility phase has been completed. The results of the study will be used to inform current and future practice and potentially reduce the risk of incisional hernia formation following midline incisions.ISRCTN 25616490 . Registered on 1 January 2012.

Project description:Background and study aims Incisional hernias are a common complication of abdominal surgery and can be defined as gaps in the wall through which abdominal contents can come through. They can cause patients significant pain, affect body image and also complications, including further major abdominal surgery. This study aims to compare two methods of closing abdominal wounds in the midline. There is the traditional technique of mass closure, involving all layers of the abdominal wall being closed symmetrically at regular points along the wound, and the Hughes repair, which involves closing all layers of the abdominal wall being closed at regular points in a near and far distribution (i.e two sutures close to the midline and two sutures further apart). The idea of the Hughes repair is to distribute tension of the suture closing along different points in the wound and therefore reducing the rate of 'cut through' and development of hernias. Who can participate? Patients must be 18 or over, and receive surgical treatment for colorectal cancer which requires a midline incision of 5 cm or more. What does the study involve? Patients who agree to take part in the study will be invited to consent to take part in the study. This study aims to compare two methods of closing abdominal wounds in the midline. The patients are randomly allocated to mass closure or Hughes repair. At the end of the study we will compare the two groups for pain, body image concerns and also complications. What are the possible benefits and risk of participating? There will be no direct benefits to those taking part. There should be benefits to future patients undergoing abdominal surgery as we think that the Hughes Repair will help to prevent condition that causes significant problems for patients. The patients we have selected to be part of the study will be undergoing CT scans as part of their normal follow up for colorectal cancer so there is no additional radiation exposure and they will also be routinely followed up as standard in all hospitals, so there is no additional time expenditure for patients or expense for the NHS. The abdomen closure techniques to be used in the study trial are already used in surgery so there is no danger to patients. Where will the study run from? The study has been set up to run from the University Hospital of Wales, Cardiff, involving the Welsh Barbers Research Group. Swansea Clinical Trials Unit are conducting the trial on behalf of sponsor Cardiff & Vale University Health Board. Participating centres will be UK wide. When is the study starting and how long is it expected to run for? Feasibility phase recruited from October 2013 till February 2014. The pilot phase that will run directly into the main phase started in August 2014 and is expected to recruit until February 2018. Who is funding the study? The Health Technology Assessment (HTA) programme (UK) Who is the main contact? Professor Jared Torkington HART@wales.nhs.uk

Project description:IntroductionThe optimal closure of the abdominal wall after emergency midline laparotomy is still a matter of debate due to lack of evidence. Although closure of the fascia using a continuous, all-layer suture technique with slowly absorbable monofilament material is common, complications like burst abdomen and hernia are frequent.Methods and analysisThis randomised controlled trial with a 1:1 allocation evaluates the efficacy and safety of a continuous suture with or without additional interrupted retention sutures for closure of the abdominal fascia. Patients with an indication for a primary emergency midline laparotomy are eligible to participate in this study and will be randomised intraoperatively via block randomisation. Fascia closure in the intervention group will be done with a standard continuous suture with slowly absorbable monofilament material (MonoMax 1, B. Braun, Tuttlingen, Germany) and additional interrupted retention sutures every 2 cm of the fascia using rapidly absorbable braided material (Vicryl 2, Ethicon, Norderstedt, Germany). In the control group, the fascia is closed only with the standard continuous suture with slowly absorbable monofilament material. Sample size calculations (n=111 per study arm) are based on the available literature. The primary endpoint is the rate of dehiscence of the abdominal fascia (rate of burst abdomen within 30 days or rate of incisional hernia within 12 months). Secondary endpoints are wound infections, quality of life, length of hospital stay, morbidity and mortality. Patients as well as individuals involved in data collection, endpoint assessment, data analysis and quality of life assessment will be blinded.Ethics and disseminationThe study protocol, the patient information and the informed consent form have been approved by the ethics committee of the Ludwig-Maximilians-University, Munich, Germany (reference number: 20-1041). Study findings will be submitted for publication in peer-reviewed journals.Trial registration numberDRKS00024802.Who universal trial numberU1111-1259-1956.

Project description:BackgroundHigh-level evidence regarding the technique of abdominal wall closure for patients undergoing emergency midline laparotomy is sparse. Therefore, we conducted a randomized controlled trial (RCT) to evaluate the efficacy and safety of two commonly applied abdominal wall closure strategies after primary emergency midline laparotomy.Methods/designCONTINT was a multi-center pragmatic open-label exploratory randomized controlled parallel trial. Two different abdominal wall closure strategies in patients undergoing primary midline laparotomy for an emergency surgical intervention with a suspected septic focus in the abdominal cavity were compared: the continuous, all-layer suture and the interrupted suture technique. The primary composite endpoint was burst abdomen within 30 days after surgery or incisional hernia within 12 months. As reliable data on this composite primary endpoint were not available for patients undergoing emergency surgery, it was planned to initially recruit 80 patients and conduct an interim analysis after these had completed the 12 months follow-up.ResultsFrom August 31, 2009, to June 28, 2012, 124 patients were randomized of whom 119 underwent surgery and were analyzed according to the intention-to-treat (ITT) principal. The primary composite endpoint did not differ between the continuous suture (C: 27.1%) and the interrupted suture group (I: 30.0%). None of the individual components of the primary endpoint (reoperation due to burst abdomen after 30 days (C: 13.5%, I: 15.1%) and reoperation due to incisional hernia (C: 3.0%, I:11.1%)) differed between groups. Time needed for fascial closure was longer in the interrupted suture group (C: 12.8 ± 4.5 min, I: 17.4 ± 6.1 min). BMI was associated with burst abdomen during the first 30 days with an OR of 1.17 (95% CI 1.04-1.32).ConclusionThis RCT showed no difference between continuous suture with slowly absorbable suture versus interrupted rapidly absorbable sutures after primary emergency midline laparotomy in rates of postoperative burst abdomen and incisional hernia after one year. However, the trial was stopped after the interim analysis due to futility as there was no chance to show superiority of one suture technique.

Dataset Information

Randomised-controlled feasibility trial on abdominal wall closure techniques in patients undergoing relaparotomy (ReLap study; DRKS00013001).

Background

Methods

Results

Discussion

Trial registration

Publications

Randomised-controlled feasibility trial on abdominal wall closure techniques in patients undergoing relaparotomy (ReLap study; DRKS00013001).

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets