Diverting Loop Ileostomy: With or Without Rod (ROLLI)

This study is currently recruiting participants.
Verified September 2013 by University Hospital Inselspital, Berne
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00959738
First received: August 14, 2009
Last updated: September 24, 2013
Last verified: September 2013

August 14, 2009
September 24, 2013
August 2008
December 2014   (final data collection date for primary outcome measure)
Severe stoma specific morbidity rate [ Time Frame: postoperative during 2 weeks, 3 months postoperative ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00959738 on ClinicalTrials.gov Archive Site
  • 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 ]
  • postoperative during 2 weeks, 3 months postoperative [ 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 ]
  • 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 ]
  • 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 ]
Not Provided
 
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

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ileostomy
  • Rectal Neoplasms
  • Procedure: Diverting loop ileostomy with rod
    Diverting loop ileostomy with rod
  • Procedure: diverting loop ileostomy without rod
    diverting loop ileostomy without rod
  • A
    diverting loop ileostomy with rod
    Intervention: Procedure: Diverting loop ileostomy with rod
  • B
    diverting loop ileostomy without rod
    Intervention: Procedure: diverting loop ileostomy without rod

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Barbara Uhlmann, Study Nurse +41 31 632 23 26 barbara.uhlmann@insel.ch
Switzerland
 
NCT00959738
061/08
No
Lukas Bruegger MD, Bern University Hospital, Department of Visceral Surgery
University Hospital Inselspital, Berne
Not Provided
Principal Investigator: Lukas E Bruegger, MD Bern University Hospital,Dep. of Visceral and Transplant Surgery Switzerland
University Hospital Inselspital, Berne
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP