Hughes Abdominal Repair Trial - abdominal wall closure techniques to reduce incidence of incisional hernias: a multi-centre pragmatic randomised trial

Cardiff & Vale University Health Board0 个研究点目标入组 830 人开始时间: 2012年8月1日最近更新: 2022年8月29日

适应症

试验速览

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)

•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

•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

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