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

Primary Purpose

Colo-rectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Early reversal of a defunctiong ileostomy
Sponsored by
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colo-rectal Cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Feasibility of early reversal of adefunctioning ileostomy
Feasibility will be measured by recording post operative complications according to Clavien- Dindo classification

Secondary Outcome Measures

Full Information

First Posted
December 30, 2021
Last Updated
December 30, 2021
Sponsor
National Cancer Institute, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT05192018
Brief Title
Reversal of a Defunctioning Ileostomy 3 Weeks After the Index Operation, RCT
Official Title
Reversal of a Defunctioning Ileostomy 3 Weeks After the Index Operation, RCT
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 25, 2021 (Actual)
Primary Completion Date
July 25, 2023 (Anticipated)
Study Completion Date
July 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colo-rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Early reversal of a defunctiong ileostomy
Intervention Description
Early reversal of a defunctiong ileostomy after 3 weeks of its creation
Primary Outcome Measure Information:
Title
Feasibility of early reversal of adefunctioning ileostomy
Description
Feasibility will be measured by recording post operative complications according to Clavien- Dindo classification
Time Frame
1 month after the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yasser A Debakey
Phone
01001340579
Ext
+2
Email
y.eldebakey@cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M Mahmoud, Professor
Phone
01001729571
Ext
+2
Email
drbarbary@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Mahmoud, Professor
Organizational Affiliation
National Cancer Institute, Cairo University, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
National Cancer Institute
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed M Mahmoud, Professor
Phone
01001729571
Ext
+2
Email
drbarbary@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In a publication
IPD Sharing Time Frame
After publication and for a year
IPD Sharing Access Criteria
In the Journal of publication

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

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