HART: Hughes Abdominal Repair Trial

Trial Overview

Acronym	HART
Number	ISRCTN Number: 25616490
Protocol Link	https://www.ncbi.nlm.nih.gov/pubmed/27634489
Public Trial Registry Link	http://www.controlled-trials.com/ISRCTN25616490
Status	In Follow-Up
Category	Miscellaneous
Treatment Course	Surgery

Trial Description

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. The primary outcome measure is the incidence of incisional hernias at 1 year as assessed by standardised clinical examination.

Chief Investigator

Jared Torkington
Mr

Profile Link

Lead Centre

University Hospital of Wales
Heath Park
Cardiff
CF14 4XW
UK

Website

Collaboration and Funding

Collaborative Sites

Funding Sponsors

Additional Information

Full Research Summary

Objective:	The primary objective is to compare the incidence of incisional hernias over one year from colorectal cancer surgery between the Hughes and standard mass closure.
Aim:	The study aims to assess the potential of an alternative wound closure method to prevent incisional hernias; a common and sometimes serious complication of abdominal surgery.
Methods:	This is a multi-centre, single (patient) blinded, randomised controlled trial. In addition to patient blinding, the reviewing radiologists and clinical examiners will be blinded, but the closing surgeons will not. The study is split into three phases; feasibility, pilot and main. Participants will be randomised in equal proportions into one of two arms; to be closed either by a standard mass closure or using a Hughes repair technique. A total of 830 patients will be randomised across all three phases, 415 to each arm. The pilot and main phase of the study will recruit 800 patients (400 to each arm) and contribute to the main study analysis.
Reason for International Trial:	The trial is not international, UK only.