High Transsphincteric Perianal FistulaNCT02994524
Intersphincteric Approach to Perianal Fistula With High Risk for Postoperative Fecal Incontinence
A study testing Rerouting technique for transsphincteric perianal fistula in people with High Transsphincteric Perianal Fistula, run by Yasser Mohamed Abdel-samii.
Trial summary
.Rerouting operation takes the advantage of minimal recurrence rate as well as minimal incontinence that is associated with less sphincter division,It is indicated in patients with transsphincteric fistula in whom lay open is expected to be associated with significant incontinence . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Transsphincteric Perianal Fistula
- What is being tested?
- Rerouting technique for transsphincteric perianal fistula
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Oct 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High arching transsphincteric fistula
- Transsphincteric fistula with high internal opening
- Transsphincteric fistula with short anal canal.
- Horseshoe perianal fistula fulfilling above criteria.
Who cannot join
- Transsphincteric fistula.
- Low perianal fistula.
About this study
.Rerouting operation takes the advantage of minimal recurrence rate as well as minimal incontinence that is associated with less sphincter division,It is indicated in patients with transsphincteric fistula in whom lay open is expected to be associated with significant incontinence .
Read the detailed description
Lay open is the classic surgical management for Peri Anal fistula,however division of significant portion of anal sphincter may be divided with postoperative fecal incontinence,Many surgical techniques have been described for sphincter preservation ,But unfortunately associated high recurrence rate.Rerouting operation takes the advantage of minimal recurrence rate as well as minimal incontinence that is associated with less sphincter division,It is indicated in patients with transsphincteric fistula in whom lay open is expected to be associated with significant incontinence .The operation is done in tow stages ,the first is to mobilize the transsphincteric part into the inter sphincteric plane thus converting it to intersphincteric fistula which is then laid open , with division of internal sphincter with preserving external sphincter.
- Conditions
- High Transsphincteric Perianal Fistula
- Being tested
- Rerouting technique for transsphincteric perianal fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rerouting technique for transsphincteric perianal fistulaProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| transsphincteric perianal fistula | Other | Rerouting technique done in patients with high transsphincteric fistula or with high internal opening. Receives: Procedure: Rerouting technique for transsphincteric perianal fistula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rerouting technique decrease incidence of fecal incontinice after high transsphincteric perianal fistula surgery .
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startFeb 2014
- Primary completionMar 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Transsphincteric Perianal FistulaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yasser Mohamed Abdel-samii
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yasser Mohamed Abdel-samii, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994524
- Sponsor's protocol ID
- 06379
- Status last verified
- Dec 2016
- First submitted
- 8 Dec 2016
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intersphincteric Approach to Perianal Fistula With High Risk for Postoperative Fecal Incontinence
- ClinicalTrials.gov ID
- NCT02994524
- Acronym / sponsor ID
- 06379
- Conditions
- High Transsphincteric Perianal Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Yasser Mohamed Abdel-samiiUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 16 Dec 2016 (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.
.Rerouting operation takes the advantage of minimal recurrence rate as well as minimal incontinence that is associated with less sphincter division,It is indicated in patients with transsphincteric fistula in whom lay open is expected to be associated with significant incontinence .
Detailed description
Lay open is the classic surgical management for Peri Anal fistula,however division of significant portion of anal sphincter may be divided with postoperative fecal incontinence,Many surgical techniques have been described for sphincter preservation ,But unfortunately associated high recurrence rate.Rerouting operation takes the advantage of minimal recurrence rate as well as minimal incontinence that is associated with less sphincter division,It is indicated in patients with transsphincteric fistula in whom lay open is expected to be associated with significant incontinence .The operation is done in tow stages ,the first is to mobilize the transsphincteric part into the inter sphincteric plane thus converting it to intersphincteric fistula which is then laid open , with division of internal sphincter with preserving external sphincter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transsphincteric perianal fistula | Other | Procedure: Rerouting technique for transsphincteric perianal fistulaRerouting technique done in patients with high transsphincteric fistula or with high internal opening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- High arching transsphincteric fistula
- Transsphincteric fistula with high internal opening
- Transsphincteric fistula with short anal canal.
- Horseshoe perianal fistula fulfilling above criteria.
Key exclusion criteria (2 listed)
- Transsphincteric fistula.
- Low perianal fistula.
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 |
|---|---|---|
| Rerouting technique for transsphincteric perianal fistula | Procedure or surgery | transsphincteric perianal fistula |
Primary outcome
Rerouting technique decrease incidence of fecal incontinice after high transsphincteric perianal fistula surgery .
Time frame: one year
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 Dec 2016.
- Individual participant dataSharing planned: Undecided
Related trials for High Transsphincteric Perianal Fistula
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Recruiting
Ligation of Intersphincteric Fistula Tract Versus Cyanoacrylate Glue in One-Stage Management of High Transsphincteric Perianal Fistula
High Transsphincteric Perianal Fistula
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 Rerouting technique for transsphincteric perianal fistula in people with High Transsphincteric Perianal Fistula, run by Yasser Mohamed Abdel-samii.
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 4 inclusion and 2 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 Dec 2016. 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?
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?
Rerouting technique decrease incidence of fecal incontinice after high transsphincteric perianal fistula surgery . (time frame: one year). 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 16 Dec 2016.