Intracutaneously versus transcutaneously sutured ileostomy:
A randomized multicenter trial (ISI trial).

In colorectal surgery, an ileostomy is often constructed to protect temporarily a distal colonic anastomosis. Even though the construction of an ileostomy is a procedure commonly performed by both general and colorectal surgeons, it has a high morbidity rate. In several studies the complication rate varied between 21 and 60 per cent. Thus, receiving an ileostomy has been associated with a decreased quality of life and a reduced physical and psycological well being.

Enterostomal therapists see many stoma-related complications, for example leakage of feces under the stoma plaque. This in turn can cause peristomal dermatitis, granuloma and fungal infections.

The objective of this trial is to compare the effectiveness of intracutaneously versus transcutaneously sutured ileostomy to reduce leakage, costs and to improve patients’quality of life. The transcutaneous character of the stitches can cause skin irritation around the stitches, it might cause leakage of feces under the stoma plaque thereby increasing skin irritation and early release of stoma plaque. This will also increase costs, because the stoma materials will have to be changed more often.

The trial is designed as a 10-center randomized clinical trial including all patients who receive an ileostomy. Patients will be randomized to receive either an intracutaneously or transcutaneously sutured ileostomy. Primary outcomes are leakage, skin irritation, costs and the patients’ quality of life.

In order to detect an effect size of 0.05 at a 5% two-sided significance level with a power of 80%, a minimum sample size of 134 patients per treatment group is required. Patients will be included from September 2010 until March 2012, with a minimum follow-up duration of three months.

An intracutaneously sutured ileostomy may be more effective than a transcutaneously sutured ileostomy to reduce peristomal dermatitis, leakage and costs and to improve quality of life of patients with an ileostomy.

1. Skin irritation and stoma related morbidity: At one week, two weeks, one month, two and three months;

2. !uality of life: One month and three months;

3. Cost analysis with a diary up to three months.

The objective of this trial is to compare the effectiveness of intracutaneously versus transcutaneously sutured ileostomy to reduce leakage, costs and to improve patients’quality of life. The transcutaneous character of the stitches can cause skin irritation around the stitches, it might cause leakage of feces under the stoma plaque thereby increasing skin irritation and early release of stoma plaque. This will also increase costs, because the stoma materials will have to be changed more often.



The trial is designed as a 10-center randomized clinical trial including all patients who receive an ileostomy. Patients will be randomized to receive either an intracutaneously or transcutaneously sutured ileostomy.