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Effect of suture technique on the occurrence of incisional hernia after elective midline abdominal wall closure: study protocol for a randomized controlled trial.

ABSTRACT: Based on a recent meta-analysis, a continuous suture technique with a suture to wound length ratio of at least 4:1, using a slowly absorbable monofilament suture material, is recommended for primary median laparotomy closure. Incisional hernia, which develops in 9 to 20% of patients, remains the major complication of abdominal wall closure. Current clinical data indicate that the incidence of incisional hernias increases by 60% between the first and the third year after median laparotomy, implicating that a follow-up period of 1 year postoperatively is too short with regard to this common complication. Trauma to the abdominal wall can be reduced by improvements in suture technique as well as suture material. Several factors, such as stitch length, suture tension, elasticity, and tensile strength of the suture material are discussed and currently under investigation. A Swedish randomized controlled trial showed a significant reduction in the incisional hernia rate by shortening the stitch length. However, a non-elastic thread was used and follow-up ended after 12 months. Therefore, we designed a multicenter, international, double-blinded, randomized trial to analyze the influence of stitch length, using an elastic, extra-long term absorbable monofilament suture, on the long term clinical outcome of abdominal wall closure.In total, 468 patients undergoing an elective, median laparotomy will be randomly allocated to either the short stitch or the long stitch suture technique for abdominal wall closure in a 1:1 ratio. Centers located in Germany and Austria will participate. The primary endpoint measure is the incisional hernia rate 1 year postoperatively, as verified by ultrasound. The frequency of short term and long term complications as well as costs, length of hospital stay and patients' quality of life (EQ-5D-5 L) will be considered as secondary parameters. Following hospital discharge, patients will be examined after 30 days and 1, 3, and 5 years after surgery.This study will provide further evidence on whether a short stitch suture technique in combination with an elastic, extra-long term absorbable monofilament suture can prevent incisional hernias in the long term, compared with the long stitch suture technique.NCT01965249 .

SUBMITTER: Fortelny RH

PROVIDER: S-EPMC4336759 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature

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Effect of suture technique on the occurrence of incisional hernia after elective midline abdominal wall closure: study protocol for a randomized controlled trial.

Fortelny René H RH Baumann Petra P Thasler Wolfgang E WE Albertsmeier Markus M Riedl Stefan S Steurer Wolfgang W Kewer Jan Ludolf JL Shamiyeh Andreas A

Trials 20150215

<h4>Background</h4>Based on a recent meta-analysis, a continuous suture technique with a suture to wound length ratio of at least 4:1, using a slowly absorbable monofilament suture material, is recommended for primary median laparotomy closure. Incisional hernia, which develops in 9 to 20% of patients, remains the major complication of abdominal wall closure. Current clinical data indicate that the incidence of incisional hernias increases by 60% between the first and the third year after median ...[more]

PMID: 25887884

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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:BackgroundRecent genetic studies identified common mutations between diverticular disease and connective tissue disorders, some of which are associated with abdominal wall hernias. Scarce data exists, however, shedding light on the potential clinical implications of this shared etiology, particularly in the era of laparoscopic surgery.MethodsThe New York Statewide Planning and Research Cooperative System database was used to identify adult patients undergoing elective sigmoid and left hemicolectomy (open or laparoscopic) from January 1, 2010, to December 31, 2016, for diverticulitis or descending/sigmoid colon cancer. The incidences of incisional hernia diagnosis and repair were compared using competing risks regression models, clustered by surgeon and adjusted for a host of demographic/clinical variables. Subsequent abdominal surgery and death were considered competing risks.ResultsAmong 8279 patients included in the study cohort, 6811 (82.2%) underwent colectomy for diverticulitis and 1468 (17.8%) for colon cancer. The overall 5-year risk of incisional hernia was 3.5% among patients with colon cancer, regardless of colectomy route, which was significantly lower than that among diverticulitis patients after both open (10.7%; p < 0.001) and laparoscopic (7.2%; p = 0.007) colectomies. Multivariable analyses demonstrated that patients with diverticulitis experienced a two-fold increase in the risk for hernia diagnosis (aHR 1.8; p < 0.001) and repair (aHR 2.1; p < 0.001), and these findings persisted after stratification by colectomy route.ConclusionsPatients undergoing elective colectomy for diverticulitis, including via laparoscopic approach, experience higher rates of incisional hernia compared with patients undergoing similar resections for colon cancer. When performing resections for diverticulitis, surgeons should strongly consider adherence to evidence-based guidelines for fascial closure to prevent this important complication.

Dataset Information

Effect of suture technique on the occurrence of incisional hernia after elective midline abdominal wall closure: study protocol for a randomized controlled trial.

Publications

Effect of suture technique on the occurrence of incisional hernia after elective midline abdominal wall closure: study protocol for a randomized controlled trial.

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