High Anal FistulaNCT04796376
The Outcome of Combined Partial Fistulectomy or Fistulotomy and Cutting Seton Procedure in High Perianal Fistula
A study testing combined partial fistulectomy or fistulotomy and cutting seton procedure in people with High Anal Fistula, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this study is to assess the effectiveness and suitability of the tight (cutting) seton as a surgical treatment of high anal fistula combined with partial fistulotomy or fistulectomy in a prospective study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- High Anal Fistula
- What is being tested?
- combined partial fistulectomy or fistulotomy and cutting seton procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2020to Mar 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult with age of or above 18 years.
- Patients with high perianal fistula; trans-sphincteric, intra-sphincteric or supra-sphincteric.
- Patients sable to comply to with the study protocol.
Who cannot join
- Patients with low perianal fistula
- Patients with preoperative incontinence.
- Patients with comorbidities such as TB , malignancy or inflammatory bowel disease.
- Patients diagnosed with acute anal sepsis
- Recurrent cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Outcome of Combined Partial Fistulectomy or Fistulotomy and Cutting Seton Procedure in High Perianal Fistula: Prospective Study
The aim of this study is to assess the effectiveness and suitability of the tight (cutting) seton as a surgical treatment of high anal fistula combined with partial fistulotomy or fistulectomy in a prospective study.
Read the detailed description
Anal fistula is an abnormal tract with two openings: external one opens in perianal skin and the internal one opens in anal canal. And according to relation between fistula and anal sphincters there are intersphincteric, transphincteric, suprasphincteric and extrasphincteric. Varieties of surgical procedures are encountered for management of this disease but complications such as recurrence and incontinence still facing surgeons strongly. In previous study of total 31 patients post-operative complications were; incontinence of gas (16.13%), incontinence of stool (3.23%), recurrence (3.23%) with conclusion of that: outcomes of fistulotomy with cutting seton were satisfactory in most patients (1). In this study and aiming to reduce the complications rate data will be collected about the outcomes of combined partial fistulectomy or fistulotomy and cutting seton procedure in a prospective study. The goals of treatment are draining infection, eradicating the fistulous tract and avoiding persistent or recurrent disease while preserving anal sphincter function.
- Conditions
- High Anal Fistula
- Being tested
- combined partial fistulectomy or fistulotomy and cutting seton procedure
- Keywords
- Cutting seton, Fistulectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined partial fistulectomy or fistulotomy and cutting seton procedureProcedure or surgery
Partial excision of fistulous tract or just fistulotomy plus cutting seton procedure which is a rubber band or threads put through fistulous tract
| Study group | Role | What they receive |
|---|---|---|
| Cutting seton | Other | A piece of surgical thread that's left in the fistula for several weeks to keep it open. This allow it to drain and help its heal. Receives: Procedure: combined partial fistulectomy or fistulotomy and cutting seton procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Cure of high perianal fistulas -Reduce incontinence rate
Cure from the main problem of the patient and prevent its recurrence
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start10 Oct 2020
- Primary completionOct 2021 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Anal FistulaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Nabil Zaher, Assiut University
- Investigators
- Mina Nb Zaher, Resident doc, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796376
- Sponsor's protocol ID
- AssiutU MNZaher
- Status last verified
- Feb 2021
- First submitted
- 19 Feb 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcome of Combined Partial Fistulectomy or Fistulotomy and Cutting Seton Procedure in High Perianal Fistula: Prospective Study
- ClinicalTrials.gov ID
- NCT04796376
- Acronym / sponsor ID
- AssiutU MNZaher
- Conditions
- High Anal Fistula
- Keywords
- Cutting seton, Fistulectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 12 Mar 2021 (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 of this study is to assess the effectiveness and suitability of the tight (cutting) seton as a surgical treatment of high anal fistula combined with partial fistulotomy or fistulectomy in a prospective study.
Detailed description
Anal fistula is an abnormal tract with two openings: external one opens in perianal skin and the internal one opens in anal canal. And according to relation between fistula and anal sphincters there are intersphincteric, transphincteric, suprasphincteric and extrasphincteric. Varieties of surgical procedures are encountered for management of this disease but complications such as recurrence and incontinence still facing surgeons strongly. In previous study of total 31 patients post-operative complications were; incontinence of gas (16.13%), incontinence of stool (3.23%), recurrence (3.23%) with conclusion of that: outcomes of fistulotomy with cutting seton were satisfactory in most patients (1). In this study and aiming to reduce the complications rate data will be collected about the outcomes of combined partial fistulectomy or fistulotomy and cutting seton procedure in a prospective study. The goals of treatment are draining infection, eradicating the fistulous tract and avoiding persistent or recurrent disease while preserving anal sphincter function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cutting seton | Other | Procedure: combined partial fistulectomy or fistulotomy and cutting seton procedureA piece of surgical thread that's left in the fistula for several weeks to keep it open. This allow it to drain and help its heal. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult with age of or above 18 years.
- Patients with high perianal fistula; trans-sphincteric, intra-sphincteric or supra-sphincteric.
- Patients sable to comply to with the study protocol.
Key exclusion criteria (5 listed)
- Patients with low perianal fistula
- Patients with preoperative incontinence.
- Patients with comorbidities such as TB , malignancy or inflammatory bowel disease.
- Patients diagnosed with acute anal sepsis
- Recurrent cases
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 |
|---|---|---|
| combined partial fistulectomy or fistulotomy and cutting seton procedurePartial excision of fistulous tract or just fistulotomy plus cutting seton procedure which is a rubber band or threads put through fistulous tract | Procedure or surgery | Cutting seton |
Primary outcome
- Cure of high perianal fistulas -Reduce incontinence rate
Time frame: 1 year
Cure from the main problem of the patient and prevent its recurrence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
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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.
Mina Nb Zaher, Resident doc principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined partial fistulectomy or fistulotomy and cutting seton procedure in people with High Anal Fistula, run by Assiut 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 3 inclusion and 5 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 12 Mar 2021. 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?
Results are not available in the source record.
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?
- Cure of high perianal fistulas -Reduce incontinence rate (time frame: 1 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 12 Mar 2021.