Diverting Loop Ileostomy: With or Without Rod (ROLLI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University Hospital Inselspital, Berne
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00959738
First received: August 14, 2009
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Ileostomy
Rectal Neoplasms
Procedure: Diverting loop ileostomy with rod
Procedure: diverting loop ileostomy without rod

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Severe stoma specific morbidity rate [ Time Frame: postoperative during 2 weeks, 3 months postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of patients reaching self-sufficient stoma care [ Time Frame: postoperative during 2 weeks ] [ Designated as safety issue: Yes ]
  • Time used by the stoma nurses for instructing and assisting patients [ Time Frame: preoperative, 2 weeks and 3 months postoperative ] [ Designated as safety issue: No ]
    Measured in total hours from the intervention up to 3 months postoperatively

  • Quality of life (QoL) by a stoma quality of life scale [ Time Frame: postoperative during 2 weeks, 3 months postoperative ] [ Designated as safety issue: No ]
  • Predictive factors for stomal complications [ Time Frame: postoperative during 2 weeks, 3 months postoperative ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Length of hospital stay, measured in days after intervention [ Time Frame: postoperative during 2 weeks, 3 months postoperative ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Start of stomal activity in hours after intervention [ Time Frame: postoperative during 2 weeks, 3 months postoperative ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: August 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A
diverting loop ileostomy with rod
Procedure: Diverting loop ileostomy with rod
Diverting loop ileostomy with rod
B
diverting loop ileostomy without rod
Procedure: diverting loop ileostomy without rod
diverting loop ileostomy without rod

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959738

Contacts
Contact: Madeleine Künzi, Study Nurse +41 31 632 23 26 Madeleine.Kuenzi@insel.ch

Locations
Switzerland
Bern University Hospital, Dep. of Visceral and Transplant Surgery Recruiting
Bern, Switzerland, 3010
Contact: Lukas E Bruegger, MD    +41 31 632 59 37    lukas.bruegger@insel.ch   
Principal Investigator: Lukas E Bruegger, MD         
Sub-Investigator: Vanessa Banz, MD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Lukas E Bruegger, MD Bern University Hospital,Dep. of Visceral and Transplant Surgery Switzerland
  More Information

Publications:

Responsible Party: Lukas Bruegger MD, Bern University Hospital, Department of Visceral Surgery
ClinicalTrials.gov Identifier: NCT00959738     History of Changes
Other Study ID Numbers: 061/08
Study First Received: August 14, 2009
Last Updated: April 24, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
loop ileostomy
quality of life
morbidity
Rectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 09, 2014