NCT05792579

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2025

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

1.9 years

First QC Date

March 19, 2023

Last Update Submit

March 19, 2023

Conditions

Stoma Colostomy

Outcome Measures

Primary Outcomes (1)

  • Early versus late stoma closure after traumatic colorectal injuries

    Detection complications of early closuare of stoma

    Baseline

Study Arms (2)

early closure of stoma

ACTIVE COMPARATOR

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

Procedure: stoma closure

late closure of stoma

ACTIVE COMPARATOR

Detection complications of late closure of stoma.

Procedure: stoma closure

Interventions

stoma closurePROCEDURE

early closure of stoma in trauma patients

early closure of stomalate closure of stoma

Eligibility Criteria

Age10 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age between (10-50)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 8328627BACKGROUND

  • 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.

    PMID: 453467BACKGROUND

Central Study Contacts

mahgoub A mahgoub, RD

CONTACT

01066892653mahgoub449@gmail.com

radwan A mohamed, pr

CONTACT

01006921632Radwan.surgeon@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assiut

Study Record Dates

First Submitted

March 19, 2023

First Posted

March 31, 2023

Study Start

April 1, 2023

Primary Completion

February 20, 2025

Study Completion

March 20, 2025

Last Updated

March 31, 2023

Record last verified: 2023-03