Does Bowel Stimulation Before Loop Ileostomy Closure Reduce Postoperative Ileus?

NCT02559635 | Completed

• 1 other identifier: JGH-06-2015
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Number of patients with postoperative ileus

  Number of participants with post-operative ileus lasting longer than 72 hours after loop ileostomy closure and followed up until discharge

  Patients will be followed for the duration of hospital stay until discharge, about 30 days

• Postoperative length of stay

  (Revised primary outcome: Aug 9th, 2019) Due to slow recruitment, the primary outcome has been changed from postoperative ileus (POI) to postoperative length of stay (LOS). At our institution, the median LOS after loop ileostomy closure among patients managed within an Enhanced Recovery Program was 4.5 days (Garfinkle et al. Br J Surg. 2019). With a standard deviation of 4, the revised power calculations require 63 patients in each arm to identify a reduction in LOS of 2 days with the intervention (Abrisqueta et al. Dis Colon Rectum. 2014) with 80% power and an alpha=0.05. POI will remain a secondary outcome. With the new power analysis, the research team will stop and analyze the data after 126 patients have completed the study follow-up. If at this time there is no difference in LOS between the intervention and control group, the study will continue until the original sample size of 166 patients. This will ensure that the study is powered to detect a difference in both LOS and POI.

  Patients will be followed for the duration of hospital stay until discharge, about 30 days

Study Arms (2)

No bowel stimulation

NO INTERVENTION

Patients undergoing loop ileostomy closures without having had bowel stimulation beforehand

Bowel stimulation

EXPERIMENTAL

Patients undergoing loop ileostomy closures having undergone bowel stimulation beforehand

Procedure: Bowel stimulation; Drug: Nestle Resource

Interventions

Bowel stimulation PROCEDURE

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.

Bowel stimulation

Nestle Resource DRUG

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.

Bowel stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients will have undergone an anterior or low-anterior resection for malignant or benign disease with a protective loop ileostomy by a board-certified colorectal surgeon or surgical oncologist at one of the involved sites.

You may not qualify if:

• Patients with a protective ileostomy following colonic resection for Crohn's disease will be excluded from entering the study, as well as patients from whom clear and informed consent cannot be obtained.

Sponsors & Collaborators

• Jewish General Hospital: lead
• Montreal General Hospital: collaborator
• North York General Hospital: collaborator
• St. Mary's General Hospital: collaborator
• Rush University Medical Center: collaborator
• North Shore Hospital, Waitemata District Health Board: collaborator

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Study Officials

• Marylise Boutros, MD

  Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 14, 2015
• First Posted: September 24, 2015
• Study Start: December 1, 2016
• Primary Completion: January 18, 2022
• Study Completion: July 18, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Locations

CA (1)