Stoma ColostomyNCT05792579
Early Versus Late Stoma Closure After Traumatic Colorectal Injuries
A study testing stoma closure in people with Stoma Colostomy, run by Assiut University.
Trial summary
The aim is to study feasibility,advantages and disadvantages of early closure of stoma versus late closure of stoma Read more about this study
- Who is it for?
- Ages 10 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Stoma Colostomy
- What is being tested?
- stoma closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 20 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- age between (10-50)
Who cannot join
- pathological causes
- deep, open perineal tear
- Severe co-morbid conditions (uncontrolled diabetes, Hypertension)
Trial locations and contacts
No sites are listed yet.
About this study
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)
- Conditions
- Stoma Colostomy
- Being tested
- stoma closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stoma closureProcedure or surgery
early closure of stoma in trauma patients
| Study group | Role | What they receive |
|---|---|---|
| early closure of stoma | Active comparator | Detection complications of early closure of stoma in pateints with colorectal injures Receives: Procedure: stoma closure |
| late closure of stoma | Active comparator | Detection complications of late closure of stoma. Receives: Procedure: stoma closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early versus late stoma closure after traumatic colorectal injuries
Detection complications of early closuare of stoma
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion20 Feb 2025 (estimated)
- Study completion20 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stoma ColostomyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahgoub Abd Elmonem Mahgoub, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792579
- Sponsor's protocol ID
- Early and late stoma closure
- Status last verified
- Mar 2023
- First submitted
- 19 Mar 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 8328627Todd 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Stoma Closure After Traumatic Colorectal Injuries
- ClinicalTrials.gov ID
- NCT05792579
- Acronym / sponsor ID
- Early and late stoma closure
- Conditions
- Stoma Colostomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 20 Feb 2025 (estimated)
- Study completion
- 20 Mar 2025 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early closure of stoma | Active comparator | Procedure: stoma closureDetection complications of early closure of stoma in pateints with colorectal injures |
| late closure of stoma | Active comparator | Procedure: stoma closureDetection complications of late closure of stoma. |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- age between (10-50)
Key exclusion criteria (3 listed)
- pathological causes
- deep, open perineal tear
- Severe co-morbid conditions (uncontrolled diabetes, Hypertension)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stoma closureearly closure of stoma in trauma patients | Procedure or surgery | early closure of stoma, late closure of stoma |
Primary outcome
Early versus late stoma closure after traumatic colorectal injuries
Time frame: Baseline
Detection complications of early closuare of stoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Background: PubMed 8328627Taheri 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.
- Background: PubMed 453467Todd 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing stoma closure in people with Stoma Colostomy, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mahgoub A mahgoub, RD (01066892653, mahgoub449@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early versus late stoma closure after traumatic colorectal injuries (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05792579, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.