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

Status: Unknown
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 75
Healthy Volunteers: f
View:

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

Locations
Other Locations
Egypt
National Cancer Institute
RECRUITING
Cairo
Contact Information
Primary
Yasser A Debakey
y.eldebakey@cu.edu.eg
01001340579
Backup
Ahmed M Mahmoud, Professor
drbarbary@yahoo.com
01001729571
Time Frame
Start Date: 2021-12-25
Completion Date: 2023-07-25
Participants
Target number of participants: 60
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: National Cancer Institute, Egypt

This content was sourced from clinicaltrials.gov