Ligation of Inter-sphincteric Fistula Tract for Management of Anal Fistula

Anal Fistula Clinical Trial

Official title:

Long-term Outcome of Ligation of Inter-sphincteric Fistula Tract (LIFT) for Management of Trans-sphincteric Anal Fistula

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05314205
• Other study ID #: AUHS2101201
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: November 15, 2020

Study information

• Verified date: March 2022
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 15, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

Procedure:
• ligation of inter-sphincteric fistula tract
The surgical treatment was achieved through identification of the fistula by injecting hydrogen peroxide (H2O2) through the external opening. Probing of the fistulous tract by a metallic probe for proper identification of the fistula in the inter-sphincteric plane. Perpendicular skin incision (about 1 cm) was done at inter-sphinctric zone, perpendicular to the fistulous tract. Dissection between the internal and external sphincters and identification of the fistula. Finally, Ligation and transection of the tract in inter-sphinctric space followed by excision of a segment and transferred for histopathology examination. Trans-fixation suture was applied near to the internal mucosal opening of the divided tract to confirm closure using polyglactin suture 2/0. Insertion of a probe to check the closure of the tract segments. The remaining part of the tract was curetted till external opening and left for spontaneous healing.

Locations

Country	Name	City	State
Egypt	Abdulkarim Hasan	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative complication	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.	2 years