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Repair of giant midline abdominal wall hernias: "components separation technique" versus prosthetic repair : interim analysis of a randomized controlled trial.

ABSTRACT: BACKGROUND: Reconstruction of giant midline abdominal wall hernias is difficult, and no data are available to decide which technique should be used. It was the aim of this study to compare the "components separation technique" (CST) versus prosthetic repair with e-PTFE patch (PR). METHOD: Patients with giant midline abdominal wall hernias were randomized for CST or PR. Patients underwent operation following standard procedures. Postoperative morbidity was scored on a standard form, and patients were followed for 36 months after operation for recurrent hernia. RESULTS: Between November 1999 and June 2001, 39 patients were randomized for the study, 19 for CST and 18 for PR. Two patients were excluded perioperatively because of gross contamination of the operative field. No differences were found between the groups at baseline with respect to demographic details, co-morbidity, and size of the defect. There was no in-hospital mortality. Wound complications were found in 10 of 19 patients after CST and 13 of 18 patients after PR. Seroma was found more frequently after PR. In 7 of 18 patients after PR, the prosthesis had to be removed as a consequence of early or late infection. Reherniation occurred in 10 patients after CST and in 4 patients after PR. CONCLUSIONS: Repair of abdominal wall hernias with the component separation technique compares favorably with prosthetic repair. Although the reherniation rate after CST is relatively high, the consequences of wound healing disturbances in the presence of e-PTFE patch are far-reaching, often resulting in loss of the prosthesis.

SUBMITTER: de Vries Reilingh TS

PROVIDER: S-EPMC1913177 | biostudies-other | 2007 Apr

REPOSITORIES: biostudies-other

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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:OBJECTIVES:Incisional 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 SETTING:A feasibility trial (with 1:1 randomisation) conducted perioperatively during colorectal cancer surgery. PARTICIPANTS:Patients undergoing midline incisional surgery for resection of colorectal cancer. INTERVENTIONS:Comparison 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 OUTCOMES:A 30-patient feasibility trial assessed recruitment, randomisation, deliverability and early safety of the surgical techniques used. RESULTS:A 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. CONCLUSIONS:The 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 NUMBER:ISRCTN 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.

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Repair of giant midline abdominal wall hernias: "components separation technique" versus prosthetic repair : interim analysis of a randomized controlled trial.

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