PeritonitisNCT01391169
Pedicled Seromuscular Flap For Enforcement Of High Risk Intestinal Anastomoses
A study testing seromuscular flap enforcement in people with Peritonitis, run by Mansoura University at 1 site in Egypt.
Trial summary
This is a control matched prospective study evaluating the use of seromuscular flap for high risk anastomoses. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Peritonitis
- What is being tested?
- seromuscular flap enforcement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2009to Jun 2011
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all patients with high risk anastomoses
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This is a control matched prospective study evaluating the use of seromuscular flap for high risk anastomoses.
Read the detailed description
30 eligible patients have been enrolled in the study then each case was matched to a control of patients who undwerwent resection anastomosis with primary anastomosis only in the same study period in terms of age, gender, comorbidity, diagnosis.
- Conditions
- Peritonitis
- Being tested
- seromuscular flap enforcement
- Medical subject headings
- Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
seromuscular flap enforcementOther
Also called primary anastomosis only
seromuscular flap enforcement
| Study group | Role | What they receive |
|---|---|---|
| 1sup group | Active comparator | enforcement of the anastomoses with seromuscular flap Receives: Other: seromuscular flap enforcement |
| 2nd group | Placebo comparator | primary anastomosis without enforcement Receives: Other: seromuscular flap enforcement |
What is being measured
The primary outcome is the main question the study is designed to answer.
anastomotic leak
Measured: 5 weeks
Secondary outcomes (2)
operative time
Measured: 2 hours
wound complications
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startApr 2009
- Primary completionApr 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeritonitisStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Investigators
- ramadan ellithy, MD, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391169
- Sponsor's protocol ID
- seromuscular flap
- Status last verified
- Apr 2009
- First submitted
- 6 Jul 2011
- Last updated
- 11 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pedicled Seromuscular Flap For Enforcement Of High Risk Intestinal Anastomoses
- ClinicalTrials.gov ID
- NCT01391169
- Acronym / sponsor ID
- seromuscular flap
- Conditions
- Peritonitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 11 Jul 2011 (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.
This is a control matched prospective study evaluating the use of seromuscular flap for high risk anastomoses.
Detailed description
30 eligible patients have been enrolled in the study then each case was matched to a control of patients who undwerwent resection anastomosis with primary anastomosis only in the same study period in terms of age, gender, comorbidity, diagnosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1sup group | Active comparator | Other: seromuscular flap enforcementenforcement of the anastomoses with seromuscular flap |
| 2nd group | Placebo comparator | Other: seromuscular flap enforcementprimary anastomosis without enforcement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients with high risk anastomoses
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| seromuscular flap enforcementAlso: primary anastomosis onlyseromuscular flap enforcement | Other | 1sup group, 2nd group |
Primary outcome
anastomotic leak
Time frame: 5 weeks
2 secondary outcomes
operative time
Time frame: 2 hours
wound complications
Time frame: 5 weeks
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 11 Jul 2011.
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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.
ramadan ellithy, MD study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing seromuscular flap enforcement in people with Peritonitis, run by Mansoura University at 1 site in Egypt.
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 0 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 11 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does the primary outcome measure?
anastomotic leak (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
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 11 Jul 2011.