ExtraPeritoneal End Colostomy Trial (ExPECT): Feasibility phase

This study will test a surgical method of making a colostomy (or stoma) to reduce the chances of a hernia (or bulge) forming near it. The technique involves bringing the bowel out through a short tunnel underneath the muscles of the abdominal wall before attaching it to the skin as usual.

This phase will test the study processes needed for a future larger trial to answer the research question of whether it can prevent hernia formation.

100,000 people in the UK have a bowel stoma. A commonly experienced problem is a hernia (or bulge) around the stoma site (a parastomal hernia). Such hernias can lead to leakage of faecal fluid, skin irritation, cosmetic problems from the bulge and chronic pain. All of these reduce patient’s quality of life. The most serious complications are bowel blockages or loss of blood supply, both requiring emergency surgery.

An effective surgical technique is required to prevent parastomal hernia from developing in the first place as repairs once they appear aren't always successful. Early studies suggest that using a technique to tunnel the stoma inside the thin inner layer of the abdomen (peritoneum) reduces the risk of parastomal hernia.

However, those studies are small and may not have followed patients for long enough to see if they had developed parastomal hernia. Also, none of the studies asked about specific symptoms or did any assessment of the patients' quality of life after surgery.

We hope that a large scale clinical trial will tell us how well the tunnelled technique prevents hernias, reduces symptoms and improves quality of life. The aim of the proposed study is to test the running of such a trial. The work will test the willingness of patients to have the procedure and of surgeons to perform it.

We will also test the ability of questionnaires to record the symptoms and problems people have with hernias, and test the suitability of questionnaires which assess quality of life. We want to show that the questionnaires chosen are suitable to measure an improvement in quality of life with the alternative technique.