Reversal of a Defunctioning Ileostomy 3 Weeks After the Index Operation, RCT

NCT05192018 | Unknown

• 1 other identifier: Debakey3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Diverting ileostomy seems to mitigate the consequences of anastomotic leak from low rectal anastomosis. Gastrointestinal continuity is restored after a period of 6-12 weeks but it can be longer if the patient is on adjuvant chemotherapy or due to low priority given to this procedure. This exposes up to one-third of the patients to significant morbidity having an impact on the quality of life and considerable economic costs. Although no meta-analysis data determined the safety and optimal time for the closure of a temporary diversion of the small bowel, earlier reversal of ileostomies a few days after primary anastomosis reduces the length of exposure to stoma-related morbidity and may improve quality of life, reduce stoma-related costs and still protect the distal anastomosis. Herein, we aimed to assess the results of early closure of defunctioning ileostomy a week following a satisfactory anastomosis, negative air leak test and smooth post-operative course and in absence of worrisome clinical signs of anastomotic leak with optional intraoperative visualization of the anastomostic line by endoscopy immediately before closing the ileostomy.

Conditions

Colo-rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility of early reversal of adefunctioning ileostomy

  Feasibility will be measured by recording post operative complications according to Clavien- Dindo classification

  1 month after the operation

Study Arms (2)

Group A

EXPERIMENTAL

This group will have their ileostomy reversed after 3 weeks from the index operation. All procedures were performed by the same senior surgeons. The duration of the operation was noted and the ease of reversal of stoma and closure of abdominal wall were assessed on ascale of 0-10 (0 = difficult, 10 = easy) by the operating surgeons.

Procedure: Early reversal of a defunctiong ileostomy

Group B

ACTIVE COMPARATOR

This group will be discharged home after the primary colorectal surgery with a defunctioning ileostomy and brought back after an interval of 3 months ,or after completion of their adjuvant therapy, for reversal. All procedures were performed by the same senior surgeons. The duration of the operation was noted and the ease of reversal of stoma and closure of abdominal wall were assessed on ascale of 0-10 (0 = difficult, 10 = easy) by the operating surgeons.

Procedure: Early reversal of a defunctiong ileostomy

Interventions

Early reversal of a defunctiong ileostomy PROCEDURE

Early reversal of a defunctiong ileostomy after 3 weeks of its creation

Group A; Group B

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who have a defunctioning ileostomy after a colorectal surgery

You may not qualify if:

• When performed to cover unsatisfactory anastomosis
• Positive air-leak test
• Those experienced postoperative complications
• Those with preoperative (1st operation) albumin below 3.5gm/dL.
• Immunocompromised patients e.g on steroids or have uncontrolled DM.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, 11796, Egypt

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Ahmed M Mahmoud, Professor

  National Cancer Institute, Cairo University, Egypt

  STUDY DIRECTOR

Central Study Contacts

Yasser A Debakey

CONTACT

01001340579; y.eldebakey@cu.edu.eg

Ahmed M Mahmoud, Professor

CONTACT

01001729571; drbarbary@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 14, 2022
• Study Start: December 25, 2021
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: January 14, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication and for a year
• Access Criteria: In the Journal of publication

Locations

EG (1)