Back to resultsThe Outcome of Combined Partial Fistulectomy or Fistulotomy and Cutting Seton Procedure in High Perianal Fistula
Primary Purpose
High Anal Fistula
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
combined partial fistulectomy or fistulotomy and cutting seton procedure
Sponsored by
About this trial
This is an interventional treatment trial for High Anal Fistula focused on measuring Cutting seton, Fistulectomy
Eligibility Criteria
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
Sites / Locations
- Assiut University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cutting seton
Arm Description
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.
Outcomes
Primary Outcome Measures
- Cure of high perianal fistulas -Reduce incontinence rate
Cure from the main problem of the patient and prevent its recurrence
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04796376
Brief Title
The Outcome of Combined Partial Fistulectomy or Fistulotomy and Cutting Seton Procedure in High Perianal Fistula
Official Title
The Outcome of Combined Partial Fistulectomy or Fistulotomy and Cutting Seton Procedure in High Perianal Fistula: Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2020 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Anal Fistula
Keywords
Cutting seton, Fistulectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cutting seton
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
combined partial fistulectomy or fistulotomy and cutting seton procedure
Intervention Description
Partial excision of fistulous tract or just fistulotomy plus cutting seton procedure which is a rubber band or threads put through fistulous tract
Primary Outcome Measure Information:
Title
- Cure of high perianal fistulas -Reduce incontinence rate
Description
Cure from the main problem of the patient and prevent its recurrence
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mina Nb Zaher, Resident doc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
The Outcome of Combined Partial Fistulectomy or Fistulotomy and Cutting Seton Procedure in High Perianal Fistula
We'll reach out to this number within 24 hrs