Extraperitoneal End Colostomy Trial (ExPeCT): Feasibility phase v1.0
Research type
Research Study
Full title
Evaluating a technique to prevent parastomal hernias and improve symptoms and quality of life for those with stomas: A multi-centre feasibility randomised trial.
IRAS ID
291897
Contact name
Kirsty Lanyon
Contact email
Sponsor organisation
Swansea Bay University Health Board
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 31 days
Research summary
"Research Summary"
100,000 people in the UK have a bowel stoma. A commonly experienced problem is a hernia (or bulge) around the stoma site called a parastomal hernia (PH). Such hernias can lead to leakage of bodily waste fluids, skin irritation, cosmetic problems from the bulge and chronic pain. All of these reduce patient’s quality of life. The most serious problems are bowel blockages or loss of blood supply, both requiring emergency surgery.Early studies suggest that using a technique to tunnel the stoma inside the thin inner layer of the abdomen (peritoneum) reduces the risk of PH. However, those studies are small and may not have followed patients for long enough to see if they had developed a PH. Also, none of the studies asked about specific symptoms or did any assessment of the patients' quality of life after surgery.
We will ask patients who are due to have surgery to create a permanent colostomy (stoma using the colon) to participate. Participants will be allocated by chance to either the tunnelled colostomy method or the standard method. At six weeks, six months and up to one year after the operation patients will be assessed for whether a parastomal hernia has formed or not and asked to fill in questionnaires about their symptoms and quality of life with their stoma.
Participants will be engaged with through their stoma care team and/or their surgeon at various outpatient settings across three different health boards in Swansea, Cardiff and Newport.
"Summary of Results"
Parastomal hernia (PH) is a common complication affecting people who have a colostomy. PH can be a painful and debilitating condition causing a large bulge, leakages and severe skin irritation. Once present, it is difficult to treat surgically, can lead to life threatening complications and is prone to recurrence. It is not known how best to prevent PH. Research studies looking at the use of preventative mesh have not shown that it improves quality of life or reduces the need for surgery to treat PH. There are also concerns about potential complications of mesh such as pain and infection.
The extraperitoneal (EP) colostomy technique has been proposed as an alternative way to reduce the impact of PH without using mesh. The bowel is passed through a tunnel of the thin innermost layer of the abdominal wall (peritoneum) before being brought out through the muscular layers and skin. Small studies comparing this technique with the standard transperitoneal (TP) approach have shown that it may reduce the chance of PH. However there has been no large scale randomised controlled trial to evaluate this definitively.
The Extraperitoneal End Colostomy Trial (ExPECT) aims to address this gap in the research. We report the findings of a feasibility study to evaluate what is required to progress to a large scale trial, inform the design and identify barriers to be addressed.Main findings:
* The infrastructure for a multicentre study was delivered across three sites
* There were adequate numbers of eligible patients identified who were undergoing colostomy formation at each site
* When approached, the majority of eligible patients agreed to participate and to be randomised to the EP or standard TP technique
* Patients were successfully randomised and underwent treatment as per allocation
* Follow-up data for three outcome measures was collected with a high completion rate
* However, recruitment was significantly impacted by a mismatch of eligible patients to participating surgeons who were specifically trained in the technique.
* We have identified several factors to address that will increase the number of available surgeons, or direct patients to surgeons participating in the study.REC name
Wales REC 7
REC reference
21/WA/0208
Date of REC Opinion
28 Jun 2021
REC opinion
Favourable Opinion