Title: Extending the Hughes Abdominal Repair Trial: Long-term Follow-Ups by Routine Data (exHART-FURD)
Funder: Health and Care Research Wales (Welsh Government)

Abstract: HART (the Hughes Abdominal Repair Trial, funded by the National Institute for Health Research [NIHR]) is evaluating the clinical and cost effectiveness of the Hughes technique of surgical closure in reducing incisional hernias in over 800 patients treated for colorectal cancer by surgery. The primary outcome measure in HART is the incidence of incisional hernia at one year post-surgery, although the published study protocol reflects the clinical understanding that such hernias also develop after this end-point, and explicitly allows for extended follow-up where logistically possible (for instance, in patients recruited in HART’s early days). Surgical trial reporting guidelines updated since the inception of HART now recommend a minimum two year follow-up as standard. In its forthcoming report to the NIHR, HART will, while fulfilling its contractual obligations, therefore only partially comply with these current guidelines. To maximise patient benefits and clinical findings from the NIHR's investment in HART, we now propose to undertake an extended follow-up of the whole HART study population, using the existing HART study infrastructure. This will take advantage of an unprecedented opportunity to follow up many hundreds of colorectal cancer patients for three, four and even five or more years post-surgery, and hence ensure that HART’s findings remain relevant in the context of current clinical practice. We propose to undertake this extended follow-up primarily through data routinely collected within the National Health Service (NHS) and UK Office for National Statistics (ONS), obtained via NHS Digital and the Welsh Government-funded Secure Anonymised Information Linkage (SAIL) Databank. This proposed extended follow-up, with analysis and reporting based closely on that developed for and used by HART, will allow us, at modest cost and with minimal further burden on study patients, to answer fundamental questions about the development of incisional hernias in terms of their timing, the risk factors involved, and the efficacy of computed tomography scans as a tool to predict future clinically relevant hernias that are undetected by standard clinical techniques such as palpation.

Lay abstract: Bowel Cancer UK estimate that there are approximately 42,000 new diagnoses of bowel cancer in the UK per annum, with surgery being the most common treatment. Surgery undertaken to treat colorectal cancer frequently leads to the development of a hernia within the abdomen around the line used in operating on the patient. This is known as an incisional hernia. These complications are painful and limit the quality of life of those suffering from them; they are also expensive to treat, often requiring further surgery. It is of considerable benefit to patients to determine the extent to which alternatives to current standard surgical techniques offer better treatment. The Hughes Abdominal Repair Trial (HART), which opened to recruitment in 2014, is a large randomised controlled trial of the Hughes technique of stomach wall closure as an alternative to standard surgical practice. The HART study protocol, published in the journal Trials in 2017, gives further details, including a brief description and illustration of the Hughes technique. The HART study team will soon report on rates of incisional hernia at one year post -surgery. Although all 802 participants in HART will, by the end of March 2020, have been followed up for at least two years after their operation, the reporting timetable for HART means that not all two year follow-up data will be included in the HART report. Based on existing study arrangements, we now seek to bring HART into line with current guidelines for reporting on surgical trials, which recommend a minimum of two years follow-up. We propose to extend the follow-up period for the whole HART study population to a minimum of three years, and to report on incisional hernia rates at two to five years post -surgery. We will do this, at a modest cost and with minimal further burden on study patients, using routine data, collected by the NHS and the ONS, to count the number of patients in HART who are still alive and have had no hernia by the two year follow-up end-point (which, for the last patient recruited into HART, is the end of March 2020) and then updating these counts for the three year follow-up end-point (the end of March 2021 for the last patient recruited into HART). As well as ensuring that the HART study complies with current best practice in reporting surgical trials, the proposed extended follow-up will provide a more complete assessment of the effectiveness of the Hughes technique, and hence considerably strengthen the evidence-base on closure techniques following surgery for colorectal cancer. Should HART and this proposed extended follow-up show that the Hughes technique has clinically significant advantages over current standard surgical practice, then the patient benefits will be immediate, long-standing and widespread, being applicable throughout the NHS and internationally.

Research activity codes: 6.4 SURGERY
Health categories: ORAL AND GASTROINTESTINAL