- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04796376
The Outcome of Combined Partial Fistulectomy or Fistulotomy and Cutting Seton Procedure in High Perianal Fistula
March 11, 2021 updated by: Mina Nabil Zaher, Assiut University
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Assiut, Egypt
- Assiut University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Cutting seton
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.
|
Partial excision of fistulous tract or just fistulotomy plus cutting seton procedure which is a rubber band or threads put through fistulous tract
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
- Cure of high perianal fistulas -Reduce incontinence rate
Time Frame: 1 year
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Cure from the main problem of the patient and prevent its recurrence
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mina Nb Zaher, Resident doc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 10, 2020
Primary Completion (Anticipated)
October 1, 2021
Study Completion (Anticipated)
March 1, 2023
Study Registration Dates
First Submitted
February 19, 2021
First Submitted That Met QC Criteria
March 11, 2021
First Posted (Actual)
March 12, 2021
Study Record Updates
Last Update Posted (Actual)
March 12, 2021
Last Update Submitted That Met QC Criteria
March 11, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AssiutU MNZaher
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Societa Italiana di Chirurgia ColoRettaleTerminated
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Groupe Hospitalier Paris Saint JosephCompletedComplex Anal FistulaFrance
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Dr Benjamin NEBBOTSuspended
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University of Southern DenmarkOdense University HospitalCompleted
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