Ligation of Inter-sphincteric Fistula Tract for Management of Anal Fistula
Sponsor
Al-Azhar University (Other)
Overall Status
Completed
CT.gov ID
NCT05314205
Collaborator
(none)
24
1
22.5
1.1
Study Details
Study Description
Brief Summary
After abscess formation, an anal fistula is a common consequence, with crypto-glandular infection being the most commonly accepted causative cause. The goal of this study was to see how well closure of the inter-sphincteric fistula tract affects the outcome of trans-sphincteric fistula surgery. Patients with perianal trans-sphincteric fistulas who underwent ligation were studied prospectively. All patients had the identical anesthetic approach, followed by the operation with two years' follow-up.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
24 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Long-term Outcome of Ligation of Inter-sphincteric Fistula Tract (LIFT) for Management of Trans-sphincteric Anal Fistula
Actual Study Start Date
:
Jan 1, 2019
Actual Primary Completion Date
:
Nov 1, 2020
Actual Study Completion Date
:
Nov 15, 2020
Outcome Measures
Primary Outcome Measures
- Post-operative complication [2 years]
The post-operative follow-up was done in an outpatient setting, with weekly visits for the first month, every two months for six months and then by phone calls to know recurrence and infection occurrence.
Eligibility Criteria
Criteria
Ages Eligible for Study:
14 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Men and women with trans-sphincteric peri-anal fistulas (according to magnetic resonance fistulogram) of crypto-glandular source with no previous fistula surgery
Exclusion Criteria:
- Individuals with recurrent fistulae or had specific pathology, like Crohn's disease.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Abdulkarim Hasan | Cairo | Egypt | 11884 |
Sponsors and Collaborators
- Al-Azhar University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Abdulkarim Hasan,
Laboratory coordinator,
Al-Azhar University
ClinicalTrials.gov Identifier:
NCT05314205
Other Study ID Numbers:
- AUHS2101201
First Posted:
Apr 6, 2022
Last Update Posted:
Apr 6, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: