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Does Bowel Stimulation Before Loop Ileostomy Closure Reduce Postoperative Ileus?

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ClinicalTrials.gov Identifier: NCT02559635
Recruitment Status : Recruiting
First Posted : September 24, 2015
Last Update Posted : August 19, 2019
Sponsor:
Collaborators:
Montreal General Hospital
North York General Hospital
St. Mary's General Hospital
Rush University Medical Center
North Shore Hospital, Waitemata District Health Board
Information provided by (Responsible Party):
Dr. Marylise Boutros, Jewish General Hospital

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.


Condition or disease Intervention/treatment Phase
Postoperative Ileus Procedure: Bowel stimulation Drug: Nestle Resource Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Bowel Stimulation Before Loop Ileostomy Closure Reduce Postoperative Ileus? A Multicenter Randomized Controlled Trial
Study Start Date : December 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
No Intervention: No bowel stimulation
Patients undergoing loop ileostomy closures without having had bowel stimulation beforehand
Experimental: Bowel stimulation
Patients undergoing loop ileostomy closures having undergone bowel stimulation beforehand
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.




Primary Outcome Measures :
  1. Number of patients with postoperative ileus [ Time Frame: Patients will be followed for the duration of hospital stay until discharge, about 30 days ]
    Number of participants with post-operative ileus lasting longer than 72 hours after loop ileostomy closure and followed up until discharge

  2. Postoperative length of stay [ Time Frame: Patients will be followed for the duration of hospital stay until discharge, about 30 days ]
    (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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02559635


Contacts
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Contact: Marylise Boutros, MD 5143408222 ext 3256 mboutros@jgh.mcgill.ca
Contact: Sarah Sabboobeh, MSc 51434082222 ext 22773 sarah.samfaris@gmail.com

Locations
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Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Sarah Sabboobeh, M.Sc.    5143408222 ext 22773    sarah.samfaris@gmail.com   
Contact: Marylise Boutros, MD    5143408222 ext 8400    mboutros@jgh.mcgill.ca   
Sponsors and Collaborators
Jewish General Hospital
Montreal General Hospital
North York General Hospital
St. Mary's General Hospital
Rush University Medical Center
North Shore Hospital, Waitemata District Health Board
Investigators
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Principal Investigator: Marylise Boutros, MD Jewish General Hospital
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Responsible Party: Dr. Marylise Boutros, Assistant Professor, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT02559635    
Other Study ID Numbers: JGH-06-2015
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases