Early Versus Late Stoma Closure After Traumatic Colorectal Injuries

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05792579
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Anticipated Duration (Months): 23.6

Study Details

Study Description

Brief Summary

The aim is to study feasibility,advantages and disadvantages of early closure of stoma versus late closure of stoma

Condition or Disease	Intervention/Treatment	Phase
Stoma Colostomy	Procedure: stoma closure	N/A

Detailed Description

Most traumatic colon injuries can be repaired primarily, but a stoma may still be required for severe colonic or rectal injury. The current trend is to reverse the stoma early, rather than to wait the traditional 3 months before closure)1-3) Trauma patients, however, are usually young and otherwise healthy individuals, with an excellent potential for optimal healing once they have overcome the initial insult. It is these patients who could benefit from early closure of the stoma(4-6). Once the temporary stoma has been constructed, various reasons have been cited for the development of colon-related complications after closure. The timing of the operation, the age of the patient, the type of colostomy, and the use of primary or delayed skin closure have all been implicated(7-8). Of all these, the timing of the operation is the most controversial. The early closure of a temporary stoma has many attractions. It can reduce hospitalization time and cost, eliminates the need for stoma care by the patient, and abolishes the psychologic, social, and financial burdens of a stoma in an otherwise healthy person(9-11)

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Early Versus Late Stoma Closure After Traumatic Colorectal Injuries
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Feb 20, 2025
• Anticipated Study Completion Date: Mar 20, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: early closure of stoma Detection complications of early closure of stoma in pateints with colorectal injures	Procedure: stoma closure; early closure of stoma in trauma patients
Active Comparator: late closure of stoma Detection complications of late closure of stoma.	Procedure: stoma closure; early closure of stoma in trauma patients

Outcome Measures

Primary Outcome Measures

1. Early versus late stoma closure after traumatic colorectal injuries [Baseline]

   Detection complications of early closuare of stoma

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• age between (10-50)

Exclusion Criteria:

• pathological causes

• deep, open perineal tear

• Severe co-morbid conditions (uncontrolled diabetes, Hypertension)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Taheri PA, Ferrara JJ, Johnson CE, Lamberson KA, Flint LM. A convincing case for primary repair of penetrating colon injuries. Am J Surg. 1993 Jul;166(1):39-44. doi: 10.1016/s0002-9610(05)80579-3.
• Todd GJ, Kutcher LM, Markowitz AM. Factors influencing the complications of colostomy closure. Am J Surg. 1979 Jun;137(6):749-51. doi: 10.1016/0002-9610(79)90086-2.

• Responsible Party: Mahgoub Abd Elmonem Mahgoub, assiut, Assiut University
• ClinicalTrials.gov Identifier: NCT05792579
• Other Study ID Numbers: Early and late stoma closure
• First Posted: Mar 31, 2023
• Last Update Posted: Mar 31, 2023
• Last Verified: Mar 1, 2023

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

Study Results

No Results Posted as of Mar 31, 2023