Clinical trial NCT00959738: Diverting Loop Ileostomy: With or Without Rod
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ileostomy
Rectal Neoplasms
Keywords: loop ileostomy
quality of life
morbidity
Rectal Neoplasms
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2009-08-17
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* patients scheduled for planned protective loop ileostomy

Exclusion Criteria

* patients with long-term use of corticosteroids (\> 15 mg prednisolone equivalent)
* immunosuppressive agent rapamune

Primary outcomes:
measure: Severe stoma specific morbidity rate
timeFrame: postoperative during 2 weeks, 3 months postoperative
Secondary outcomes:
measure: Rate of patients reaching self-sufficient stoma care
timeFrame: postoperative during 2 weeks
measure: Time used by the stoma nurses for instructing and assisting patients
timeFrame: preoperative, 2 weeks and 3 months postoperative
measure: Quality of life (QoL) by a stoma quality of life scale
timeFrame: postoperative during 2 weeks, 3 months postoperative
measure: Predictive factors for stomal complications
timeFrame: postoperative during 2 weeks, 3 months postoperative
Other outcomes:
measure: Length of hospital stay, measured in days after intervention
timeFrame: postoperative during 2 weeks, 3 months postoperative
measure: Change in eversion of the stoma nipple at postoperative days 2, 4, 6, 8, 14, 30, 60, 90
timeFrame: postoperative days 2, 4, 6, 8, 14, 30, 60, 90
measure: Start of stomal activity in hours after intervention
timeFrame: postoperative during 2 weeks, 3 months postoperative
measure: Number of stoma bags and self-adhesive plates needed in the first month after the operation
timeFrame: postoperative during 2 weeks, 3 months postoperative
Locations:
city: Bern
country: Switzerland
facility: Bern University Hospital, Dep. of Visceral and Transplant Surgery
Study officials:
affiliation: Bern University Hospital,Dep. of Visceral and Transplant Surgery Switzerland
name: Lukas E Bruegger, MD
role: PRINCIPAL_INVESTIGATOR
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