Abdominal hernia/elective colorectal cancer surgery Digestive System Other abdominal hernia
Conditions
Interventions
Participants will be assigned to either Hughes Repair or mass closure repair of midline incisions.
Sponsors
Cardiff & Vale University Health Board
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 21/04/2015: 1. At screening: 1.1. Patients aged 18 years or older 1.2. Able to give informed consent 1.3. Both standard mass closure and the Hughes repair closure are suitable closing techniques for the patient 1.4. An elective patient for colorectal cancer surgery following full staging investigations including an abdominal CT scan OR an emergency patient with a strong suspicion of colorectal cancer as per CT 2. At point of surgical closure/randomisation: 2.1. Midline abdominal incision (open or laparoscopic assisted/converted) 2.2. Incision of 5 cm or more Previous inclusion criteria: 1. Patients aged 18 years or older, who are undergoing colorectal cancer surgery with a midline incision (open or laparoscopic assisted). 2. Emergency admissions - providing the patient is able to give informed consent 3. Patients with previous abdominal surgery (non-virgin abdomens) 4. Patients with a previous midline incisional hernia 5. Patients undergoing laparoscopic resections involving midline mini-laparotomies for specimen retrieval
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 21/04/2015: 1. At screening: 1.1. Unable to provide informed consent 2. At point of surgical closure/randomisation: 2.1. Inserting a mesh as part of abdominal closure 2.2. Undergoing musculofascial flap closure of perineal defect in abdomino-perineal wound closure Previous exclusion criteria: 1. Patients under 18 years old 2. Pfannenstiel incisions, no midline incisions 3. Patient who are not able to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 d | — |
Countries
United Kingdom, Wales
Outcome results
None listed