Diverting Loop Ileostomy: With or Without Rod (ROLLI)

November 13, 2014 updated by: University Hospital Inselspital, Berne

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Bern University Hospital, Dep. of Visceral and Transplant Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: A
diverting loop ileostomy with rod
Procedure: Diverting loop ileostomy with rod
Diverting loop ileostomy with rod
OTHER: B
diverting loop ileostomy without rod
Procedure: diverting loop ileostomy without rod
diverting loop ileostomy without rod

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of patients reaching self-sufficient stoma care
Time Frame: postoperative during 2 weeks
postoperative during 2 weeks
Time used by the stoma nurses for instructing and assisting patients
Time Frame: preoperative, 2 weeks and 3 months postoperative
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
Time Frame: postoperative during 2 weeks, 3 months postoperative
postoperative during 2 weeks, 3 months postoperative
Predictive factors for stomal complications
Time Frame: postoperative during 2 weeks, 3 months postoperative
postoperative during 2 weeks, 3 months postoperative

Other Outcome Measures

Outcome Measure
Time Frame
Length of hospital stay, measured in days after intervention
Time Frame: postoperative during 2 weeks, 3 months postoperative
postoperative during 2 weeks, 3 months postoperative
Change in eversion of the stoma nipple at postoperative days 2, 4, 6, 8, 14, 30, 60, 90
Time Frame: postoperative days 2, 4, 6, 8, 14, 30, 60, 90
postoperative days 2, 4, 6, 8, 14, 30, 60, 90
Start of stomal activity in hours after intervention
Time Frame: postoperative during 2 weeks, 3 months postoperative
postoperative during 2 weeks, 3 months postoperative
Number of stoma bags and self-adhesive plates needed in the first month after the operation
Time Frame: postoperative during 2 weeks, 3 months postoperative
postoperative during 2 weeks, 3 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Lukas E Bruegger, MD, Bern University Hospital,Dep. of Visceral and Transplant Surgery Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

August 14, 2009

First Submitted That Met QC Criteria

August 14, 2009

First Posted (ESTIMATE)

August 17, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 14, 2014

Last Update Submitted That Met QC Criteria

November 13, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 061/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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