Anal FistulaNCT03636997
Treatment of Complex Anal Fistula With Draining Seton With or Without Rerouting of Track
A study testing Draining seton and Rerouting of track in people with Anal Fistula, run by Mansoura University at 1 site in Egypt.
Trial summary
This randomized trial aimed to compare conventional draining seton with or without rerouting of the fistula track in treatment of complex anal fistula Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anal Fistula
- What is being tested?
- Draining seton and Rerouting of track
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2017to 30 Jul 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients of both genders aging below 60 years old with complex crypto-glandular anal fistula were included. Complex anal fistula were defined as high trans-sphincteric anal fistulas involving more than 30% of the external anal sphincter fibers, suprasphincteric, extrasphincteric, and horse-shoe fistula
Who cannot join
- Patients with simple anal fistula.
- Patients with acute anorectal sepsis.
- Patients with secondary anal fistula caused by inflammatory bowel diseases, sexually transmitted diseases, malignancy, or irradiation.
- Patients with associated anorectal conditions as hemorrhoids, anal fissure, rectal prolapse, or malignancy.
- Patients with history of previous surgical treatment of anal fistula.
- Patients with symptomatic preoperative fecal incontinence.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura university hospital
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Treatment of Complex Anal Fistula With Draining Seton With or Without Rerouting of the Fistula Track: a Randomized Controlled Trial
This randomized trial aimed to compare conventional draining seton with or without rerouting of the fistula track in treatment of complex anal fistula
Read the detailed description
Placement of seton is typically employed when the fistula track is involving more than 30% of the external anal sphincter. However, attempts to reroute the seton and the involved fistula track were made to preserve the external anal sphincter fibers and hasten healing of the anal wound. Mann and Clifton first introduced a transposition technique for the management of high anal and anorectal fistulas by re-routing the extrasphincteric portion of the track into an intersphincteric position with immediate repair of the external sphincter and reported successful outcomes of five patients in terms of quick healing and preserved anal continence.
The present study aimed to evaluate the outcome of draining seton with or without rerouting of the fistula track in treatment complex high anal fistula regarding healing time, postoperative pain, and incidence of recurrence and FI postoperatively. We hypothesized that rerouting the seton to include the fistula track and the internal anal sphincter only, preserving the external anal sphincter muscles, would serve to hasten healing and decrease the incidence of recurrence and continence disturbances.
- Conditions
- Anal Fistula
- Being tested
- Draining seton, Rerouting of track
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Draining setonProcedure or surgery
Number 1 silk suture was passed through the fistula track and tied as loose seton
Rerouting of trackProcedure or surgery
The seton and fistula track were rerouted to involve the internal anal sphicnter only and spare the external sphincter
| Study group | Role | What they receive |
|---|---|---|
| Draining seton | Active comparator | Draining seton is placed through the fistula track and internal and external anal sphicnters Receives: Procedure: Draining seton |
| Rerouting of track | Active comparator | The seton and the fistula track are rerouted to include the internal anal sphincter only and spare the external anal sphincter Receives: Procedure: Rerouting of track |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing time
Time required to achieve complete healing of the anal fistula
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Feb 2017
- Primary completion28 Feb 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anal FistulaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Emile, Mansoura University
- Investigators
- Sameh Emile, M.D., Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636997
- Sponsor's protocol ID
- Mansoura63
- Status last verified
- Aug 2018
- First submitted
- 16 Aug 2018
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Omar W, Alqasaby A, Abdelnaby M, Youssef M, Shalaby M, Anwar Abdel-Razik M, Emile SH. Drainage Seton Versus External Anal Sphincter-Sparing Seton After Rerouting of the Fistula Tract in the Treatment of Complex Anal Fistula: A Randomized Controlled Trial. Dis Colon Rectum. 2019 Aug;62(8):980-987. doi: 10.1097/DCR.0000000000001416.
PubMed 31162376
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Complex Anal Fistula With Draining Seton With or Without Rerouting of the Fistula Track: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03636997
- Acronym / sponsor ID
- Mansoura63
- Conditions
- Anal Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 17 Aug 2018 (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.
This randomized trial aimed to compare conventional draining seton with or without rerouting of the fistula track in treatment of complex anal fistula
Detailed description
Placement of seton is typically employed when the fistula track is involving more than 30% of the external anal sphincter. However, attempts to reroute the seton and the involved fistula track were made to preserve the external anal sphincter fibers and hasten healing of the anal wound. Mann and Clifton first introduced a transposition technique for the management of high anal and anorectal fistulas by re-routing the extrasphincteric portion of the track into an intersphincteric position with immediate repair of the external sphincter and reported successful outcomes of five patients in terms of quick healing and preserved anal continence.
The present study aimed to evaluate the outcome of draining seton with or without rerouting of the fistula track in treatment complex high anal fistula regarding healing time, postoperative pain, and incidence of recurrence and FI postoperatively. We hypothesized that rerouting the seton to include the fistula track and the internal anal sphincter only, preserving the external anal sphincter muscles, would serve to hasten healing and decrease the incidence of recurrence and continence disturbances.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Draining seton | Active comparator | Procedure: Draining setonDraining seton is placed through the fistula track and internal and external anal sphicnters |
| Rerouting of track | Active comparator | Procedure: Rerouting of trackThe seton and the fistula track are rerouted to include the internal anal sphincter only and spare the external anal sphincter |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients of both genders aging below 60 years old with complex crypto-glandular anal fistula were included. Complex anal fistula were defined as high trans-sphincteric anal fistulas involving more than 30% of the external anal sphincter fibers, suprasphincteric, extrasphincteric, and horse-shoe fistula
Key exclusion criteria (6 listed)
- Patients with simple anal fistula.
- Patients with acute anorectal sepsis.
- Patients with secondary anal fistula caused by inflammatory bowel diseases, sexually transmitted diseases, malignancy, or irradiation.
- Patients with associated anorectal conditions as hemorrhoids, anal fissure, rectal prolapse, or malignancy.
- Patients with history of previous surgical treatment of anal 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 |
|---|---|---|
| Draining setonNumber 1 silk suture was passed through the fistula track and tied as loose seton | Procedure or surgery | Draining seton |
| Rerouting of trackThe seton and fistula track were rerouted to involve the internal anal sphicnter only and spare the external sphincter | Procedure or surgery | Rerouting of track |
Primary outcome
Healing time
Time frame: 6 months after surgery
Time required to achieve complete healing of the anal fistula
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 17 Aug 2018.
- Derived from this study: PubMed 31162376Omar W, Alqasaby A, Abdelnaby M, Youssef M, Shalaby M, Anwar Abdel-Razik M, Emile SH. Drainage Seton Versus External Anal Sphincter-Sparing Seton After Rerouting of the Fistula Tract in the Treatment of Complex Anal Fistula: A Randomized Controlled Trial. Dis Colon Rectum. 2019 Aug;62(8):980-987. doi: 10.1097/DCR.0000000000001416.
- Individual participant dataSharing planned: No
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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.
Sameh Emile, M.D. principal investigator
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 Draining seton and Rerouting of track in people with Anal Fistula, 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 6 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 17 Aug 2018. 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. 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?
Healing time (time frame: 6 months after surgery). 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 NCT03636997, which also lists 1 linked publication.
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 17 Aug 2018.