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

NCT ID: NCT05192018

Last Updated: 2022-01-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-25
• Study Completion Date: 2023-07-25

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.

Detailed Description

All consecutive patients coming to National Cancer Institute of Cairo university, having a defunctioning ileostomy during a low rectal or anal anastomosis or even for obstructive purposes, will be considered eligible and offered to participate in the trial. Patients currently on steroids, at high cardiorespiratory risk and those experiencing any postoperative complication will be excluded. Informed written consent will be obtained from the patients. The remaining patients were randomized into early (Group A) and late (Group B) reversal groups using sealed envelopes. Group A will have their ileostomy reversed after 3 weeks from the index operation within one hospital admission, while group B will be discharged home 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. Postoperative complications were recorded in concordance with the definitions of Dindo et al. [5]. Costs associated with stoma care (consumables and nurse visits)were calculated. Baseline and preoperative characteristics of the patients. Baseline demographics (age, gender, ECOG score, smoking, DM, BMI) and immediate postoperative outcome (complications, if any, like anastomotic leakage, ileus, wound problems and others, rate of reoperation, and 30-day mortality) will be analyzed as well.

Exclusion criteria

• 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.

Conditions

Colo-rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

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.

Group Type: EXPERIMENTAL

Early reversal of a defunctiong ileostomy

Intervention Type: PROCEDURE

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

Group B

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.

Group Type: ACTIVE_COMPARATOR

Early reversal of a defunctiong ileostomy

Intervention Type: PROCEDURE

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

Interventions

Early reversal of a defunctiong ileostomy

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmed M Mahmoud, Professor

Role: STUDY_DIRECTOR

National Cancer Institute, Cairo University, Egypt

Locations

National Cancer Institute

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Yasser A Debakey

Role: CONTACT

y.eldebakey@cu.edu.eg

01001340579 ext. +2

Ahmed M Mahmoud, Professor

Role: CONTACT

drbarbary@yahoo.com

01001729571 ext. +2

Facility Contacts

Ahmed M Mahmoud, Professor

Role: primary

drbarbary@yahoo.com

01001729571 ext. +2

Other Identifiers

Debakey3

Identifier Type: -

Identifier Source: org_study_id