Loop Ileostomy Closure as a 23-hour Stay Procedure, a Multi-center Randomized Controlled Trial (ILEO)

June 11, 2019 updated by: CHU de Quebec-Universite Laval
The purpose of this study is to assess the safety and feasibility of ileostomy closure performed in a 23 hours hospitalization setting, using a multi-center, open-label, randomized controlled trial comparing patients being hospitalized overnight (discharged on the day after surgery) to patients being hospitalized as per the current conventional care after ileostomy closure with both groups following a standardized enhanced recovery after surgery (ERAS) pathway specific to ileostomy closure. Primary outcome will be total length of hospital stay in days and secondary outcomes, measured at 30 days, will include readmission rate, postoperative complication rate minor and severe, postoperative ileus rate, postoperative surgical site infection rate and mortality rate.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Rationale :

Loop ileostomy is defined by bringing a loop of small bowel out onto the surface of the skin to allow diversion of the fecal stream. It is a common procedure that is conjointly done with colorectal surgeries with the objective to protect intestinal anastomosis at high risk of leaking. Loop ileostomy closure is then performed in the months following the initial surgery when the anastomosis has healed. Often thought of as a simple procedure, it is still associated with a significant postoperative morbidity rate consisting mostly of postoperative ileus. In the CHU de Québec-Université Laval, patients are hospitalized for a median of five days until their bowels open up while no active care is given. This represents 645 days of hospitalization each year for Hôpital Saint-François d'Assise (HSFA), Hôtel-Dieu de Québec (HDQ) and Centre Hospitalier de l'Université Laval (CHUL). Hence, there is a clear need to determine if the investigator can improve the outcomes following ileostomy closure by applying a standardized enhanced recovery pathway specific to ileostomy closure to the point where the surgery can be performed in a twenty-three hours hospitalization setting.

Objective :

The purpose of this study is to assess the safety and feasibility of ileostomy closure performed in a 23 hours hospitalization setting, using a multi-center, open-label, randomized controlled trial comparing patients being hospitalized overnight (discharged on the day after surgery) to patients being hospitalized as per the current conventional care after ileostomy closure with both groups following a standardized enhanced recovery after surgery (ERAS) pathway specific to ileostomy closure. Primary outcome will be total length of hospital stay in days and secondary outcomes, measured at 30 days, will include readmission rate, postoperative complication rate minor and severe, postoperative ileus rate, postoperative surgical site infection rate and mortality rate.

Hypothesis :

The investigator believes patients randomized to the group 23-hour stay will have reduced total length of hospital stay compared to patients randomized to the group conventional hospitalization after ileostomy closure.

Methods :

Healthy adults (ASA I and II) undergoing elective ileostomy closure who consented to take part in the study will be enrolled in a standardized enhanced recovery pathway specific to ileostomy closure. Once surgery is completed, they will be randomized to either 23-hour stay or conventional hospitalization. Data on postoperative outcomes will be gathered prospectively until 30 days after surgery and will include total length of hospital stay in days, readmissions, postoperative complications, more precisely postoperative ileus and surgical site infections, as well as mortality.

Clinical significance :

If safety and feasibility of a fast discharge of patients is demonstrated by this study, it would then mean that patients could be discharged from hospital less than 24 hours after a loop ileostomy closure. It could potentially lower the consequences of a long hospital stay for patients, such as risks of nosocomial infections, thromboembolic events, and hospital acquired autonomy loss.

Study Type

Interventional

Enrollment (Anticipated)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
      • Québec, Canada, G1R 2J6
        • Hotel-Dieu de Quebec
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xavier Paré, MD
        • Principal Investigator:
          • Geneviève Morin, MD
    • Quebec
      • Québec, Quebec, Canada, G1L 3L5
        • Hopital Saint-Francois d'Assise
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xavier Paré, MD
        • Principal Investigator:
          • Geneviève Morin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 years and older
  • Able to provide informed consent
  • ASA I and II (American Society of Anesthesiologists)
  • Staying less than 50 kilometers from a hospital after surgery
  • Being accompanied by an adult able to assist the patient in his recovery and to intervene in case of an emergency for the first 48 hours after surgery
  • No anastomotic leak proven on preoperative water soluble enema

Exclusion Criteria:

  • Language barrier or significant communication problem
  • Immunosuppression
  • Therapeutic anticoagulation
  • Previous proctocolectomy
  • Previous ileal pouch anal anastomosis
  • Technical factors during surgery (conversion to midline laparotomy or other, at surgeon's discretion)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention group (23-hour stay)
Patients randomized to the group 23-hour stay will be discharged on the day after their surgery if they meet the discharge criteria.
Other: Early discharge from hospital
Patients randomized to the group 23-hour stay will be discharged on the day after their surgery if they meet the discharge criteria.
NO_INTERVENTION: Control group (conventional hospitalization)
Patients randomized to the group conventional hospitalization will be hospitalized as per the current conventional care after ileostomy closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total length of hospital stay
Time Frame: 30 days after surgery
The number of days spent in the hospital from the time of the surgery to the time of the discharge as well as any day spent in the hospital after any readmission in the 30 days following the ileostomy closure.
30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission rate
Time Frame: 30 days after surgery
Any hospitalisation after surgery
30 days after surgery
Postoperative complication rate
Time Frame: 30 days after surgery
Any complication after surgery
30 days after surgery
Postoperative ileus rate
Time Frame: 30 days after surgery
Ileus necessitating installation of a nasogastric tube
30 days after surgery
Postoperative surgical site infection rate
Time Frame: 30 days after surgery
Infection of the surgical site
30 days after surgery
Postoperative mortality rate
Time Frame: 30 days after surgery
Death after the surgery
30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Investigators

  • Study Director: François Letarte, MD, MSc, CHU de Quebec-Universite Laval
  • Principal Investigator: Xavier Paré, MD, CHU de Quebec-Universite Laval
  • Principal Investigator: Geneviève Morin, MD, CHU de Quebec-Universite Laval

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2019

Primary Completion (ANTICIPATED)

April 1, 2021

Study Completion (ANTICIPATED)

June 1, 2021

Study Registration Dates

First Submitted

May 6, 2019

First Submitted That Met QC Criteria

May 6, 2019

First Posted (ACTUAL)

May 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 12, 2019

Last Update Submitted That Met QC Criteria

June 11, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019-4382

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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