ExtraPeritoneal End Colostomy Trial (ExPECT): Feasibility phase

End of project summary

Main Messages

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.