Diverting Loop Ileostomy: With or Without Rod

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Ileostomy, Rectal Neoplasms

Intervention / Treatment
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* Procedure: Diverting loop ileostomy with rod
* Procedure: diverting loop ileostomy without rod


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>diverting loop ileostomy with rod | Procedure: Diverting loop ileostomy with rod<br>* Diverting loop ileostomy with rod<br>|
| Other: B<br>diverting loop ileostomy without rod | Procedure: diverting loop ileostomy without rod<br>* diverting loop ileostomy without rod<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe stoma specific morbidity rate |  | postoperative during 2 weeks, 3 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients reaching self-sufficient stoma care |  | postoperative during 2 weeks | 
| Time used by the stoma nurses for instructing and assisting patients | Measured in total hours from the intervention up to 3 months postoperatively | preoperative, 2 weeks and 3 months postoperative | 
| Quality of life (QoL) by a stoma quality of life scale |  | postoperative during 2 weeks, 3 months postoperative | 
| Predictive factors for stomal complications |  | postoperative during 2 weeks, 3 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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loop ileostomy, quality of life, morbidity, Rectal Neoplasms