Trial Information

A Prospective Multicenter Randomized Controlled Clinical Trial to Compare the Method of Protective Diverting Loop Ileostomy With or Without the Support of a Plastic Rod

Background

For rectal anastomoses within 6 cm of the anal verge, leakage rates are up to 15%. Here
liberal use of protective stomas is widely accepted. Fecal diversion by loop ostomy may also
be performed after extended adhesiolysis with serosal lesions and risk of intestinal
perforation, in patients with obstructing rectal tumours requiring neoadjuvant
radio-chemotherapy or in patients with complex anorectal injuries or fistulas. Generally,
diverting loop ileostomies are secured at skin level by means of a supporting device in
order to prevent retraction of the loop ileostomy into the abdomen. Nevertheless, due to the
supporting rod, difficulties may occur in applying a stoma bag correctly and leakage of
feces onto the skin may occur even with correct eversion of the afferent limb. Despite
easier application of stoma bags and therefore reduced risk of skin irritation, none of
these alternative techniques are established. In various non-randomized studies rodless loop
ileostomies were described with an overall morbidity between 3 and 39%. However definition
of morbidity varies significantly in these studies and randomised controlled trials are
missing so far.

Objective

The aim of this study is to determine, whether a modification (without rod) of the current
standard method of protective loop ileostomy formation (with rod) could improve ileostomy
specific morbidity. Secondary endpoints include stoma care, determinants of quality of life
and stoma function.

Methods

The study is designed as multi-institutional, randomized controlled, two-armed study.
Patients scheduled for a protective loop ileostomy and meeting the eligibility criteria will
be randomized to creation of a loop ileostomy with or without sustaining rod.