Trial of Collagen Mesh for Prevention of Ventral Hernia After Surgery for Advanced Pelvic Cancer

University of Aarhus59 enrolled

Overview

The aim of the present project is to investigate whether use of biological mesh at the donor site of the rotation flap in closure of the abdominal wall reduce the frequency of incisional hernia formation compared to the usual abdominal wall closure after abdominal rotation flap operation in surgery for advanced pelvic cancer.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Incisional Hernia Pelvic Cancer

Interventions

Mesh repairPROCEDURE

A Surgisis Gold Hernia repair graft (Cook Biotech Incorporated, West Lafayette, IN, U.S.A) is placed at the donor site of the rectus abdominis muscles used for the rotation flap before the abdominal fascia is sutured with continuous running suture.

Conventional facial closurePROCEDURE

The abdominal facia is closed with with continuous running suture

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients operated with a vertical rectus abdominis musculocutaneus flap after abdominoperineal resection for advanced pelvic cancer. Exclusion Criteria: * Pre or perioperative knowledge of disseminated malignancy * Unable to follow the control program * Known allergy to pig * Compromised immune defense * Artificial heart valve or recent (\< 3 months) implanted foreign body * Age \< 18 years

Locations (1)

Surgical Research Unit, Department of Surgery P, Aarhus University Hospital

Aarhus, Denmark

Outcomes

Primary Outcomes

incisional hernia formation determined by CT scan 1 year postoperative

Time frame: 1 year postoperative

Secondary Outcomes

postoperative morbidity

Time frame: 30 days postoperative

Data from ClinicalTrials.gov

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