Does Bowel Stimulation Before Loop Ileostomy Closure Reduce Postoperative Ileus?

Summary

Postoperative ileus is the most commonly observed morbidity following ileostomy closure. Studies have previously demonstrated that the defunctionalized bowel of a loop ileostomy undergoes a series of functional and structural changes. It has been hypothesized that these changes may contribute to the development of postoperative ileus, and that stimulating the distal limb of a loop ileostomy prior to closure may functionally prepare the excluded bowel for intestinal transit.

The purpose of the multicenter, randomized controlled trial is to determine the impact of preoperative stimulation of the distal limb of a loop ileostomy on postoperative ileus.

Conditions

• Postoperative Ileus

Interventions

PROCEDURE

Bowel stimulation

Stimulation will be performed daily on an outpatient basis for the two weeks (ten business days) prior to ileostomy closure by a trained research assistant. The efferent limb of the ileostomy loop will be canalized with an 18 Fr Foley catheter and infused with a solution comprising of 500mL of normal saline mixed with 30g of a thickening-agent (Nestle Resource). It will be prepared in five 100mL syringes and administered slowly over 20 minutes.

DRUG

Nestle Resource

Stimulation will be performed daily on an outpatient basis for the two weeks (ten business days) prior to ileostomy closure by a trained research assistant. The efferent limb of the ileostomy loop will be canalized with an 18 Fr Foley catheter and infused with a solution comprising of 500mL of normal saline mixed with 30g of a thickening-agent (Nestle Resource). It will be prepared in five 100mL syringes and administered slowly over 20 minutes.

Sponsors & Collaborators

• Montreal General Hospital

  collaborator OTHER

• North York General Hospital

  collaborator OTHER

• St. Mary's General Hospital

  collaborator UNKNOWN

• Rush University Medical Center

  collaborator OTHER

• North Shore Hospital, Waitemata District Health Board

  collaborator UNKNOWN

• Jewish General Hospital

  lead OTHER

Principal Investigators

• Marylise Boutros, MD · Jewish General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-12-01

Primary Completion

2022-01-18

Completion

2022-07-18

Countries

• Canada

Study Locations