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 ileostomy construction is a common
procedure performed by both general and colorectal surgeons, it has a high
morbidity rate. In several studies the complication rate varies between 21 and
60 per cent. As a result of these complications the costs of management of a
complicated stoma are high. Thus, receiving an ileostomy is associated with a
decreased quality of life, physical and psychological well-being.
In the Netherlands it is unclear how many ileostomies are created yearly. We
estimate that there are 2000 new patients each year, while in the UK there are
as many as 9000 new ileostomies each year.
Obviously the patient who will receive an ileostomy has to be informed about
living with such a stoma. Nowadays an enterostomy nurse is active in many
hospitals. They counsel patients and surgeons to determine the proper location
of the stoma and teach the patient how to properly care for the stoma. Through
the careful follow-up by the enterostomy nurse many of the stoma-related
complications are now recognized and, if possible, dealt with appropriately.
It is important to select the optimal site for the formation of the stoma
before the operation takes place. The position for the stoma is marked with the
patient standing, bending and sitting so to make sure that the stoma is not in
a skin crease and that it is visible to the patient in all positions. An
inappropriate site leads to leakage, skin irritation, and skin break down
around the stoma.
Ileostomies produce watery and frequent stool, especially in the early
postoperative phase. The proteolytic enzymes and high alkaline content of the
stool can damage the epidermal structure. This is responsible for the increased
incidence of skin irritation. Peristomal dermatitis is a large problem for
ileostomy patients. 65% of the patients with an ileostomy have reported to have
peristomal dermatitis. One of the factors that cause peristomal dermatitis is
leakage of feces under the stomaplaque. Causes for leakage of feces are an
inappropriate site, wrong use of stoma material, retraction or a parastomal
hernia. Leakage of feces under the stoma plaque will require changing the stoma
plaque more often. This will cause extra damage to the peristomal skin.
Generally, surgeons fixate ileostomies to the skin my means of transcutaneous
stitches. There are, however, no solid data on how to create a stoma and what
kind of suture technique should be used. It can be hypothesized that the
transcutaneous character of the stitches allows feces to penetrate under the
stomaplaque and thereby increase skin irritation and early release of the
stomaplaque. Hence,it will increase costs because more stoma materials are
needed. Stitching the ileostomy intracutaneously instead of transcutaneously
may reduce the leakage of feces under the stoma plaque.

In this trial we will compare two ways of suturing the ileostomy,
intracutaneous sutures or transcutaneous sutures (hence the acronym ISI-trial;
Intracutaneously Stitched Ileostomy trial). There is no consensus about which
technique should be used. A frequently occurring stoma-related complication is
leakage of feces under the stomaplaque that can cause peristomal dermatitis.
This also causes early release of the stomaplaque, so this has to be changed
more often. The hypothesis is that the transcutaneous character of the stitches
give irritation of the skin and more readily allows feces to appear under the
stoma plaque and thereby increases skin irritation and early release of stoma
plaque. This will increase costs because more stoma material needs to be used.

Randomized single-blind multicenter trial.

Stitching the ileostomy intracutaneously instead of transcutaneously

The patient will be asked to fill in a couple of questionnaires, to keep a
diary and to visit the outpatients clinic.
The risks are mild en exit of only very rare (allergic) reactions on the used
suture material.