Hughes Abdominal Repair Trial - abdominal wall closure techniques to reduce incidence of incisional hernias

Not Applicable

Completed

• Conditions: Abdominal hernia/elective colorectal cancer surgery; Digestive System; Other abdominal hernia

• Registration Number: ISRCTN25616490
• Lead Sponsor: Cardiff & Vale University Health Board

Brief Summary

2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/27634489 protocol 2017 Interim results article in https://www.ncbi.nlm.nih.gov/pubmed/29259055 feasibility trial results 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35938554/ (added 09/08/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35979802/ (added 19/08/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-01
• Study Completion: 2019-09-30
• Last Update Posted: 29 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 830

Inclusion Criteria

Current inclusion criteria as of 21/04/2015:
1. At screening:
1.1. Patients aged 18 years or older
1.2. Able to give informed consent
1.3. Both standard mass closure and the Hughes repair closure are suitable closing techniques for the patient
1.4. An elective patient for colorectal cancer surgery following full staging investigations including an abdominal CT scan OR an emergency patient with a strong suspicion of colorectal cancer as per CT
2. At point of surgical closure/randomisation:
2.1. Midline abdominal incision (open or laparoscopic assisted/converted)
2.2. Incision of 5 cm or more

Previous inclusion criteria:
1. Patients aged 18 years or older, who are undergoing colorectal cancer surgery with a midline incision (open or laparoscopic assisted).
2. Emergency admissions - providing the patient is able to give informed consent
3. Patients with previous abdominal surgery (non-virgin abdomens)
4. Patients with a previous midline incisional hernia
5. Patients undergoing laparoscopic resections involving midline mini-laparotomies for specimen retrieval

Exclusion Criteria

Current exclusion criteria as of 21/04/2015:
1. At screening:
1.1. Unable to provide informed consent
2. At point of surgical closure/randomisation:
2.1. Inserting a mesh as part of abdominal closure
2.2. Undergoing musculofascial flap closure of perineal defect in abdomino-perineal wound closure

Previous exclusion criteria:
1. Patients under 18 years old
2. Pfannenstiel incisions, no midline incisions
3. Patient who are not able to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified