CClinicalTrials.gg
Status unknownNCT05792579Updated Mar 31, 2023

Early Versus Late Stoma Closure After Traumatic Colorectal Injuries

An interventional study of stoma closure in Stoma Colostomy, sponsored by Assiut University. Status unknown. Open to participants aged 10 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-31.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
10 Years to 50 Years
Sex
All
01

Study summary

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

Read the 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)

02

Conditions studied

  • Stoma Colostomy
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • age between (10-50)

Exclusion criteria

Exclusion Criteria:

  • pathological causes
  • deep, open perineal tear
  • Severe co-morbid conditions (uncontrolled diabetes, Hypertension)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    early closure of stoma

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

    Procedure: stoma closure

  • Active comparator
    late closure of stoma

    Detection complications of late closure of stoma.

    Procedure: stoma closure

Interventions

  • Procedurestoma closure

    early closure of stoma in trauma patients

06

What researchers measure

Primary outcomes

  1. Early versus late stoma closure after traumatic colorectal injuries

    Detection complications of early closuare of stoma

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 8328627 ↗
  • 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. PubMed 453467 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05792579
Lead sponsor
Assiut University
Responsible party
Mahgoub Abd Elmonem Mahgoub (assiut, Assiut University) — Principal investigator
First posted
Mar 31, 2023
Start date
Apr 1, 2023 (estimated)
Primary completion
Feb 20, 2025 (estimated)
Completion
Mar 20, 2025 (estimated)
Last update
Mar 31, 2023

Study contacts

mahgoub A mahgoub, RD
Contact
mahgoub449@gmail.com
01066892653
radwan A mohamed, pr
Contact
Radwan.surgeon@aun.edu.eg
01006921632

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion