Early Versus Late Stoma Closure After Traumatic Colorectal Injuries

Stoma Colostomy Clinical Trial

Official title:

Early Versus Late Stoma Closure After Traumatic Colorectal Injuries

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05792579
• Other study ID #: Early and late stoma closure
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: March 20, 2025

Study information

• Verified date: March 2023
• Source: Assiut University
• Contact: mahgoub A mahgoub, RD
• Phone: 01066892653
• Email: mahgoub449[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 20, 2025
• Est. primary completion date: February 20, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 50 Years

Eligibility

Inclusion Criteria:

• age between (10-50)

Exclusion Criteria:

• pathological causes

• deep, open perineal tear

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

Related Conditions & MeSH terms

• Stoma Colostomy

Intervention

Procedure:
• stoma closure
early closure of stoma in trauma patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early versus late stoma closure after traumatic colorectal injuries	Detection complications of early closuare of stoma	Baseline