Hughes Abdominal Repair Trial - abdominal wall closure techniques to reduce incidence of incisional hernias

Current primary outcome measures as of 21/04/2015:
The primary outcome is the incidence of incisional hernias over one year as assessed by clinical examination of the abdomen.

Previous primary outcome measures:
Incidence of incisionals hernia at one year by:
1. Radiology. The inter recti distance would be measured at a set distance from the symphysis pubis. This would be compared at subsequent CTs postoperatively. The radiologist at the local Multidisciplinary team meeting would be asked to provide an assessment of the presence of incisional hernias and this would be independently assessed.
2. Clinical examination. The clinical presence of a hernia would be assessed either by surgical doctors, who are taught to assess for this as part of their training, or by nurse specialists who either have or will have received training as part of their role. The presence of a hernia can be detected as a palpable mass, usually with a cough impulse, which may or may not cause the patient discomfort or pain.

Current secondary outcome measures as of 21/04/2015:
1. Two Quality of Life Patient Reported Outcome Measures (PROMs) will be administered at baseline, 30 days, 6 months and 1 year to assess the differences between the two trial groups. The questionnaires used will be SF-12, a shorter version of the original SF36 and the Functional Analysis of Cancer Therapy – Colorectal (FACT-C).
2. Cost-utility analysis of the Hughes Repair in relation to the mass closure in colorectal cancer patients from the perspective of the NHS will be undertaken. Information regarding resource use will be collected, focusing on surgery-specific resources including, but not limited to, open or laparoscopic surgery, duration of surgery, suture details, number and type of complications especially IHs and other SAEs, and subsequent use of health and social care. To measure the subsequent use of health and social care, an existing Client Service Receipt Inventory (CSRI) has been adapted for surgical procedures. A CSRI is a research instrument for collecting data on service use by patients, originally developed for use in Mental Health Services. The unit costs of all these resources will be estimated using published data. Incremental cost-effectiveness ratios (ICER) for IHs avoided will be calculated. SF-6D utilities will be derived from the responses to SF12 questionnaires and used to estimate changes in patients’ QoL over time. They will be combined with survival data to estimate the incremental cost per quality adjusted life year (QALY) gained.
3. Data on the incidence of post-operative ‘burst abdomen’ or full thickness abdominal wall dehiscence will be collected for up to 30 days post operation, as well as details of any repair surgery and the closing sutures used.
4. Data will be collected regarding patient conditions that are considered to be associated with an increased risk of developing hernias, including but not limited to diabetes and obesity. C-POSSUM (Colorectal - Physiological and Operative Severity Score for Understanding Mortality and Morbidity) scores, developed in 1991 and modified in 2004 to assess risk of mortality and morbidity in patients undergoing colorectal surgery, will also be completed. Analysis of these measures will estimate the effect of these factors on IH rates; and whether some patient groups derive greater benefit from the Hughes Repair than others. The presence of other hernias (incisional and non-incisional) as identified by clinical examination and CT will also contribute to the risk assessment of developing a midline incisional hernia following abdominal surgery, as some patients may be more susceptible to developing hernias. Patients who develop post-operative SSIs are also more likely to develop incisional hernias. Unfortunately SSI is one of the common complications of colorectal surgery. Data will be collected for patients developing SSIs in hospital; the SSIs will be classified into superficial, deep (involving muscle or fascia) or confined to an organ or space. On discharge, patients will be asked to keep a diary (as derived from Williams et al) for up to 30 days post-surgery to record any community-treated wound-related SSIs. Participants will be asked to return the diary at the 30-day visit or return by post, depending on site preference.
5. The prevalence of incisional hernias at one year as measured by clinical examination will be assessed. PROMs will be administered at baseline, 30 days, 6 months and 1 year.
6. The quality of life of patients with or without incisional hernias will be compared over one year. PROMs will be administered at baseline, 30 days, 6 months and 1 year to assess the differences between the two groups.

Previous secondary outcome measures:
Incidence of incisional hernia at further follow up (2-5 years):
1. Complications of surgery. One of the more common complications of colorectal surgery is surgical site infection of the wound. It has been shown that patients with wound infections are more likely to develop hernias following an surgical site infection (SSI). We aim to use a patient diary developed by Professor Leaper to assess SSI in addition to clinical staff reviewing the wound
2. Post operative pain
3. Quality of Life Analysis (SF12 and FACT-C). The Short Form 12 (SF 12) questionnaire is a validated tool for assessment of quality of life. It is a more generic assessment than the FACT-C but has other strengths. It is also a very short questionnaire and has been demonstrated to be valid and results are comparable to the commonly utilised SF36 which is more time consuming for a patient to complete.
4. Cost Analysis at one year and further follow up up (Client Service Receipt Inventory)