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

NCT05314205 | Completed

• 1 other identifier: AUHS2101201
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal Fistula

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

ligation of inter-sphincteric fistula tract PROCEDURE

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.

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from surgery clinic at AlAzhar Hospital

You may qualify if:

• Men and women with trans-sphincteric peri-anal fistulas (according to magnetic resonance fistulogram) of crypto-glandular source with no previous fistula surgery

You may not qualify if:

• Individuals with recurrent fistulae or had specific pathology, like Crohn's disease.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Abdulkarim Hasan

Cairo, 11884, Egypt

Location

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Laboratory coordinator

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 6, 2022
• Study Start: January 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: November 15, 2020
• Last Updated: April 6, 2022

Record last verified: 2022-03

Locations

EG (1)