Objectives Incisional hernias are common complications of midline abdominal closure. The ‘Hughes Repair’ combines a standard mass closure with a series of horizontal and two vertical mattress sutures within a single suture. There is evidence to suggest this technique is as effective as mesh repair for the operative management of incisional hernias; however, no trials have compared Hughes repair with standard mass closure for the prevention of incisional hernia formation. This paper aims to test the feasibility of running a randomised controlled trial of a comparison of abdominal wall closure methods following midline incisional surgery for colorectal cancer, in preparation to a definitive randomised controlled trial.
Design and setting A feasibility trial (with 1:1 randomisation) conducted perioperatively during colorectal cancer surgery.
Participants Patients undergoing midline incisional surgery for resection of colorectal cancer.
Interventions Comparison of two suture techniques (Hughes repair or standard mass closure) for the closure of the midline abdominal wound following surgery for colorectal cancer.
Primary and secondary outcomes A 30-patient feasibility trial assessed recruitment, randomisation, deliverability and early safety of the surgical techniques used.
Results A total of 30 patients were randomised from 43 patients recruited and consented, over a 5-month period. 14 and 16 patients were randomised to arms A and B, respectively. There was one superficial surgical site infection (SSI) and two organ space SSIs reported in arm A, and two superficial SSIs and one complete wound dehiscence in arm B. There were no suspected unexpected serious adverse reactions reported in either arm. Independent data monitoring committee found no early safety concerns.
Conclusions The feasibility trial found no early safety concerns and demonstrated that the trial was acceptable to patients. Progression to the pilot and main phases of the trial has now commenced following approval by the independent data monitoring committee.
Trial registration number ISRCTN 25616490.
- incisional hernia
- abdominal closure
- hughes repair
- mass closure
- randomised controlled trial
- colorectal cancer
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Contributors RLH, JC, DB, BR, ITR, JT conceived, designed and drafted the initial protocol. JH aided in redrafting and revising the protocol and contributed heavily to completion of the feasibility trial and pilot stages. SI, AW, NB, ITR have written and designed the analysis plan and revised the protocol. JC, DB, ITR, JT led the team that acquired the funding. RLH wrote the first draft of the manuscript. All authors agree to be accountable for all aspects of the work. All authors read and approved the final manuscript.
Funding The NIHR Health Technology Assessment programme requested this feasibility trial as a prerequisite for awarding grant 12/35/29 for the pilot and main phases of HART.
Competing interests None declared.
Ethics approval The study was approved by the Wales Research Ethics Committee (MREC 12/WA/0374).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data available.
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