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

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.

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Key information

Conditions

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

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Abdulkarim Hasan

Cairo, 11884, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Post-operative complication

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Apr 6, 2022
Registry last updated: Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed