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Diverting loop ileostomy with rod

diverting loop ileostomy without rod

Lukas E Bruegger, MD

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.

Diverting Loop Ileostomy: With or Without Rod

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

Measured in total hours from the intervention up to 3 months postoperatively

Insel Gruppe AG, University Hospital Bern

Lukas Bruegger MD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Diverting Loop Ileostomy: With or Without Rod	NCT00959738	Ileostomy Rectal Neoplasm...	Diverting loop ... diverting loop ...	18 Years -	Insel Gruppe AG, University Hospital Bern
Diverting Loop Ileostomy: With or Without Rod	NCT00959738	Ileostomy Rectal Neoplasm...	Diverting loop ... diverting loop ...	18 Years -	Insel Gruppe AG, University Hospital Bern
Diverting Loop Ileostomy: With or Without Rod	NCT00959738	Ileostomy Rectal Neoplasm...	Diverting loop ... diverting loop ...	18 Years -	Insel Gruppe AG, University Hospital Bern

Spots Global Cancer Trial Database for diverting loop ileostomy with rod