Early Versus Late Stoma Closure After Traumatic Colorectal Injuries

NCT ID: NCT05792579

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2025-03-20

Brief Summary

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

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)

Conditions

Stoma Colostomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

early closure of stoma

Detection complications of early closure of stoma in pateints with colorectal injures

Group Type: ACTIVE_COMPARATOR

stoma closure

Intervention Type: PROCEDURE

early closure of stoma in trauma patients

late closure of stoma

Detection complications of late closure of stoma.

Group Type: ACTIVE_COMPARATOR

stoma closure

Intervention Type: PROCEDURE

early closure of stoma in trauma patients

Interventions

stoma closure

early closure of stoma in trauma patients

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• age between (10-50)

Exclusion Criteria

• pathological causes
• deep, open perineal tear
• Severe co-morbid conditions (uncontrolled diabetes, Hypertension)

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mahgoub Abd Elmonem Mahgoub

assiut

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

mahgoub A mahgoub, RD

Role: CONTACT

mahgoub449@gmail.com

01066892653

radwan A mohamed, pr

Role: CONTACT

Radwan.surgeon@aun.edu.eg

01006921632

References

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.

Reference Type: BACKGROUND

PMID: 8328627 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 453467 (View on PubMed)

Other Identifiers

Early and late stoma closure

Identifier Type: -

Identifier Source: org_study_id