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

Not Applicable

• Conditions: Colo-rectal Cancer
• Interventions: Procedure: Early reversal of a defunctiong ileostomy

• Registration Number: NCT05192018
• Lead Sponsor: National Cancer Institute, Egypt

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.

Study Timeline

• Status Verified: 2021-12
• Study Start: 2021-12-25
• Study First Submitted: 2021-12-30
• Study First Submitted QC: 2021-12-30
• Last Update Submitted: 2021-12-30
• Study First Posted: 2022-01-14
• Last Update Posted: 2022-01-14
• Primary Completion: 2023-07-25
• Study Completion: 2023-07-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Early reversal of a defunctiong ileostomy	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 A	Early reversal of a defunctiong ileostomy	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of early reversal of adefunctioning ileostomy	1 month after the operation	Feasibility will be measured by recording post operative complications according to Clavien- Dindo classification

Trial Locations

Locations (1)

National Cancer Institute; 🇪🇬 Cairo, Egypt