Summary
Extending the Hughes Abdominal Repair Trial: Long-term Follow-Ups by Routine Data (exHARTFURD)
Funder: HCRW
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.
Contact Details
Trial Manager / Lead Contact: Prof Jared Torkington
ISCRTN Number: 25616490;