title: Hughes Abdominal Repair Trial (HART) - Abdominal wall closure techniques to reduce the incidence of incisional hernias: study protocol for a randomised controlled trial.
abstract: Incisional hernias are common complications of midline closure following abdominal surgery and cause significant morbidity, impaired quality of life and increased health care costs. The 'Hughes Repair' combines a standard mass closure with a series of horizontal and two vertical mattress sutures within a single suture. This theoretically distributes the load along the incision length as well as across it. There is evidence to suggest that this technique is as effective as mesh repair for the operative management of incisional hernias; however, no trials have compared the Hughes Repair with standard mass closure for the prevention of incisional hernia formation following a midline incision.
  
  
  
  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. Full ethical approval has been gained (Wales REC 3, MREC 12/WA/0374). Eight hundred patients will be randomised from approximately 20 general surgical units within the United Kingdom. Patients undergoing open or laparoscopic (more than a 5-cm midline incision) surgery for colorectal cancer, elective or emergency, are eligible. Patients under the age of 18 years, those having mesh inserted or undergoing musculofascial flap closure of the perineal defect in abdominoperineal wound closure, and those unable to give informed consent will be excluded. Patients will be randomised intraoperatively to either the Hughes Repair or standard mass closure. The primary outcome measure is the incidence of incisional hernias at 1 year as assessed by standardised clinical examination. The secondary outcomes include quality of life patient-reported outcome measures, cost-utility analysis, incidence of complete abdominal wound dehiscence and C-POSSUM scores. The incidence of incisional hernia at 1 year, assessed by computerised tomography, will form a tertiary outcome.
  
  
  
  A feasibility phase has been completed. The results of the study will be used to inform current and future practice and potentially reduce the risk of incisional hernia formation following midline incisions.
  
  
  
  
  
  
  
  ISRCTN 25616490 . Registered on 1 January 2012.
authors.affiliation: Department of Surgery, University Hospital of Wales, Heath Park, Cardiff, CF14 4XW, UK.
authors.forename: J
authors.initials: J
authors.lastname: Cornish
authors.affiliation: Department of Surgery, University Hospital of Wales, Heath Park, Cardiff, CF14 4XW, UK.
authors.forename: R L
authors.initials: RL
authors.lastname: Harries
authors.affiliation: Department of Surgery, University Hospital of Wales, Heath Park, Cardiff, CF14 4XW, UK.
authors.forename: D
authors.initials: D
authors.lastname: Bosanquet
authors.affiliation: Department of Surgery, University Hospital of Wales, Heath Park, Cardiff, CF14 4XW, UK.
authors.forename: B
authors.initials: B
authors.lastname: Rees
authors.affiliation: Department of Surgery, University Hospital of Wales, Heath Park, Cardiff, CF14 4XW, UK.
authors.forename: J
authors.initials: J
authors.lastname: Ansell
authors.affiliation: Department of Surgery, University Hospital of Wales, Heath Park, Cardiff, CF14 4XW, UK.
authors.forename: N
authors.initials: N
authors.lastname: Frewer
authors.affiliation: Department of Surgery, University Hospital of Wales, Heath Park, Cardiff, CF14 4XW, UK.
authors.forename: P K
authors.initials: PK
authors.lastname: Dhruva Rao
authors.affiliation: Department of Surgery, University Hospital of Wales, Heath Park, Cardiff, CF14 4XW, UK.
authors.forename: C
authors.initials: C
authors.lastname: Parry
authors.affiliation: Department of Surgery, University Hospital of Wales, Heath Park, Cardiff, CF14 4XW, UK.
authors.forename: R
authors.initials: R
authors.lastname: Ellis-Owen
authors.affiliation: Department of Surgery, University Hospital of Wales, Heath Park, Cardiff, CF14 4XW, UK.
authors.forename: S M
authors.initials: SM
authors.lastname: Phillips
authors.affiliation: Department of Surgery, University Hospital of Wales, Heath Park, Cardiff, CF14 4XW, UK.
authors.forename: C
authors.initials: C
authors.lastname: Morris
authors.affiliation: Department of Surgery, University Hospital of Wales, Heath Park, Cardiff, CF14 4XW, UK.
authors.forename: J
authors.initials: J
authors.lastname: Horwood
authors.affiliation: Department of Surgery, University Hospital of Wales, Heath Park, Cardiff, CF14 4XW, UK.
authors.forename: M L
authors.initials: ML
authors.lastname: Davies
authors.affiliation: Department of Surgery, University Hospital of Wales, Heath Park, Cardiff, CF14 4XW, UK.
authors.forename: M M
authors.initials: MM
authors.lastname: Davies
authors.affiliation: Department of Surgery, University Hospital of Wales, Heath Park, Cardiff, CF14 4XW, UK.
authors.forename: R
authors.initials: R
authors.lastname: Hargest
authors.affiliation: Department of Surgery, University Hospital of Wales, Heath Park, Cardiff, CF14 4XW, UK.
authors.forename: Z
authors.initials: Z
authors.lastname: Davies
authors.affiliation: Princess of Wales Hospital, Bridgend, UK.
authors.forename: J
authors.initials: J
authors.lastname: Hilton
authors.affiliation: Morriston Hospital, Swansea, UK.
authors.forename: D
authors.initials: D
authors.lastname: Harris
authors.affiliation: Wrexham Maelor Hospital, Wrexham, UK.
authors.forename: A
authors.initials: A
authors.lastname: Ben-Sassi
authors.affiliation: Glan Clwyd Hospital, Rhyl, UK.
authors.forename: R
authors.initials: R
authors.lastname: Rajagopal
authors.affiliation: Royal Glamorgan Hospital, Llantrisant, UK.
authors.forename: D
authors.initials: D
authors.lastname: Hanratty
authors.affiliation: Swansea Clinical Trials Unit, Swansea University, Swansea, UK.
authors.forename: S
authors.initials: S
authors.lastname: Islam
authors.affiliation: Swansea Clinical Trials Unit, Swansea University, Swansea, UK.
authors.forename: A
authors.initials: A
authors.lastname: Watkins
authors.affiliation: Swansea Clinical Trials Unit, Swansea University, Swansea, UK.
authors.forename: N
authors.initials: N
authors.lastname: Bashir
authors.affiliation: Involving People, Health and Care Research Wales, Cardiff, UK.
authors.forename: S
authors.initials: S
authors.lastname: Jones
authors.affiliation: Swansea Clinical Trials Unit, Swansea University, Swansea, UK.
authors.forename: I R
authors.initials: IR
authors.lastname: Russell
authors.affiliation: Department of Surgery, University Hospital of Wales, Heath Park, Cardiff, CF14 4XW, UK. jared.torkington@wales.nhs.uk.
authors.forename: J
authors.identifier: 0000-0002-3218-0574
authors.initials: J
authors.lastname: Torkington
mesh_terms: D034861:Abdominal Wall / Q000601:surgery*; D058107:Abdominal Wound Closure Techniques / Q000009:adverse effects / Q000191:economics; D002985:Clinical Protocols; D015179:Colorectal Neoplasms / Q000191:economics / Q000601:surgery*; D003362:Cost-Benefit Analysis; D017048:Health Care Costs; D006801:Humans; D015994:Incidence; D000069290:Incisional Hernia / Q000000981:diagnostic imaging / Q000191:economics / Q000453:epidemiology / Q000517:prevention & control*; D010535:Laparoscopy; D011788:Quality of Life; D012107:Research Design; D012307:Risk Factors; D013529:Surgical Wound Dehiscence; D013536:Suture Techniques / Q000009:adverse effects / Q000191:economics; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D006113:United Kingdom / Q000453:epidemiology
keywords: Abdominal closure; Hughes repair; Incisional hernia; Mass closure; Quality of life