Ulcerative ColitisNCT01173250
Is Diverting Ileostomy Necessary in Stapled Ileoanal Pouch?
A study testing adding diverting ileostomy and omitting diverting ileostomy in people with Ulcerative Colitis and Familial Adenomatous Polyposis, run by Mansoura University.
Trial summary
Total proctocolectomy with ileal pouch anal anastomosis is the first choice surgical operation for management of ulcerative colitis and familial adenomatous polyposis. The addition of diverting ileostomy may reduce septic complications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ulcerative Colitis, Familial Adenomatous Polyposis
- What is being tested?
- adding diverting ileostomy and omitting diverting ileostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- patients having total proctocolectomy with ileal pouch anal anastomosis.
Who cannot join
- hypoalbuminemia
- prolonged steroid use
- anemia
- anastomosis under tension
- leak with air test
- bleeding
- poor vascular supply of anastomosis
About this study
Total proctocolectomy with ileal pouch anal anastomosis is the first choice surgical operation for management of ulcerative colitis and familial adenomatous polyposis. The addition of diverting ileostomy may reduce septic complications. In this randomized study the investigators compare two groups of patients with stapled ileoanal pouch one of them had diverting ileostomy and in the other this step is omitted.
- Conditions
- Ulcerative Colitis, Familial Adenomatous Polyposis
- Being tested
- adding diverting ileostomy, omitting diverting ileostomy
- Keywords
- total proctocolectomy with ileal pouch anal anastomosis with and without ileostomy
- Medical subject headings
- Colitis, Ulcerative, Adenomatous Polyposis Coli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adding diverting ileostomyProcedure or surgery
omitting diverting ileostomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| stapled ileoanal pouch without diverting ileostomy | Active comparator | Not described Receives: Procedure: omitting diverting ileostomy |
| stapled ileoanal pouch with diverting ileostomy | Placebo comparator | Not described Receives: Procedure: adding diverting ileostomy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Mansoura 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
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173250
- Sponsor's protocol ID
- 251068
- Status last verified
- Oct 2010
- First submitted
- 30 Jul 2010
- Last updated
- 16 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Diverting Ileostomy Necessary in Stapled Ileoanal Pouch?
- ClinicalTrials.gov ID
- NCT01173250
- Acronym / sponsor ID
- 251068
- Conditions
- Ulcerative Colitis, Familial Adenomatous Polyposis
- Keywords
- total proctocolectomy with ileal pouch anal anastomosis with and without ileostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- First posted
- 2 Aug 2010 (estimated)
- 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.
Total proctocolectomy with ileal pouch anal anastomosis is the first choice surgical operation for management of ulcerative colitis and familial adenomatous polyposis. The addition of diverting ileostomy may reduce septic complications. In this randomized study the investigators compare two groups of patients with stapled ileoanal pouch one of them had diverting ileostomy and in the other this step is omitted.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stapled ileoanal pouch without diverting ileostomy | Active comparator | Procedure: omitting diverting ileostomy |
| stapled ileoanal pouch with diverting ileostomy | Placebo comparator | Procedure: adding diverting ileostomy |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients having total proctocolectomy with ileal pouch anal anastomosis.
Key exclusion criteria (7 listed)
- hypoalbuminemia
- prolonged steroid use
- anemia
- anastomosis under tension
- leak with air test
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 |
|---|---|---|
| adding diverting ileostomy | Procedure or surgery | stapled ileoanal pouch with diverting ileostomy |
| omitting diverting ileostomy | Procedure or surgery | stapled ileoanal pouch without diverting ileostomy |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing adding diverting ileostomy and omitting diverting ileostomy in people with Ulcerative Colitis and Familial Adenomatous Polyposis, run by Mansoura 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 7 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: finished, as of the sponsor's last update on 16 Aug 2010. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 16 Aug 2010.