Rectal Neoplasms Clinical Trial
Official title:
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
Diverting ileostomies are created to protect a rectal anastomosis or in situations with a risk of intestinal perforation. Currently, the application of a rod to hinder slippage of the loop is an established technique to perform a diverting loop ileostomy. However, various "rod-less" techniques have been described and are performed with similar success. 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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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