The Impact of Abdominal Wall Closure Technique on Incidence of Incisional Hernia in Kidney Transplantation

Study Design This study has two phases. In phase 1 we will perform a retrospective review of hernia incidence in our centre over the last decade. We will seek to identify risk factors in our transplant cohort. In phase 2 we will perform a prospective randomised blinded feasibility trial in which the conventional large bites technique will be compared with the small bites technique.

STUDY SETTING The study will be carried out on one site at Manchester Royal Infirmary, part of Manchester University National Health Service (NHS) Foundation Trust. This is a regional Renal and Pancreas Transplant centre performing approximately 60 pancreas transplants per annum and 350 kidney transplants. All members of the team have academic track records and participate in several on-going research projects. Current research projects are investigating cardiovascular disease, kidney perfusion, Magnetic Resonance (MR) imaging to name a few.

RESEARCH QUESTIONS, AIMS, AND OBJECTIVES

Phase 1 To retrospectively evaluate the incidence of incisional hernias in our transplant population and associated risk factors.

Phase 2

1. To perform prospective randomized double blinded feasibility trial to investigate the use of "small bites" (SB) vs "large bites (LB)" for closure of abdominal incisions following kidney transplantation.
2. To collect detailed medical histories from all patients included in the study to look for potential medical risk factors which may predispose to hernia formation.
3. To collect tissue and blood samples to investigate potential biological and histological markers of hernia formation, from both patients with end stage renal failure receiving a living-donor kidney transplant, and samples from the donor nephrectomy patients for histological comparison.
4. To assess quality of life and pain scores in the early and delayed post-operative phase (week 1, 6 months and 1 year)

Outcomes Phase 1 Incidence of Incisional Hernia within 1 and 3 years post-transplant clinically or radiologically detected.

Phase 2 Primary outcome Incidence of Incisional Hernia within one year post transplant, either clinically or radiologically detected. Any incisional hernia identified will be classified as per European Hernia Society Guidelines.

Secondary outcomes Incidence of post-operative complications at 6 months post op (burst abdomen, chest infection, surgical site infection returns to theatre,etc), pain score, costs, length of hospital stay, quality of life at week 1, 6 and 12 months post-transplant, collagen and serum biomarkers which may predispose to hernia formation

Sampling and recruitment Sample identification Phase 1 Data will be collected from the medical records of our Transplant population and entered into an excel spreadsheet no personal identifiers will be recorded.

Phase 2 The Chief Investigator (CI) and Principle Investigator (PI) will identify patients on the transplant waiting list and send copies of the information sheet.

Following ethical approval, patients undergoing first or second renal transplantation will be asked for informed consent to participate in the study to receive either small or large bites.

The CI and PI are part of the direct care team. The CI will have custody of the clinical information.

Clinical details will be recorded on hospital pass worded computers. Blood samples will be anonymised at the time of collection. Patients will be given a study code and blood samples will be labelled with this code to ensure anonymity.

The custodian of the data and samples will be the CI.Mr David van Dellen.