Two Approaches to Lower the Chances of Recurrence of Anal Fistula After Surgery

NCT06380036 | Completed

• 1 other identifier: 003AEstb/EC/01/2022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 80 patients with complex fistula in ano of both genders were included. All patients in Group A underwent a loose seton technique. In group B, video-assisted fistula tract surgery (VAAFTS) was performed.Twice daily Sitz baths, analgesics, and stool bulking agents (bran) were used in follow-up care. Repeated examinations were carried out every four weeks and recurrence was noted at the end of three months

Conditions

Fistula in Ano

Outcome Measures

Primary Outcomes (1)

• recurrence

  to see whether recurrence occur or not

  one year

Study Arms (2)

seton

EXPERIMENTAL

loose seton will be placed in the pts with fistula in ano. All patients in Group A underwent the loose seton technique. The procedures were performed in the operating room with the patient in the lithotomy position. Probing of the fistula tract was done with a metallic malleable probe. The incision was given from the external opening of the fistula to the anal verge, involving the skin, subcutaneous tissue, superficial part of the external sphincter, and superficial part of the internal sphincter. After the insertion of loose Seton, a non-absorbable suture was left loosely and kept in situ for three months.

Procedure: video assisted fistula tract surgery

VAAFTS

EXPERIMENTAL

In group B, video-assisted fistula tract surgery (VAAFTS) was performed. The patients were positioned in the lithotomy position. The fistuloscope was then introduced into the external opening and the procedure was performed, except for the closure of the internal opening, which was performed with either a "figure of eight" suture or an advancement flap, rather than using a stapler. The tracts were destroyed using electrocautery, the necrotic tissues were removed, and the external openings were cored out and left open for drainage

Procedure: video assisted fistula tract surgery

Interventions

video assisted fistula tract surgery PROCEDURE

in one group pt recieved VAAFTS

Also known as: Loose setone

VAAFTS; seton

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• complex fistula in ano (as per operational definition)
• with a duration of disease \>1 month,
• either gender
• history of previous surgery for fistula in ano

You may not qualify if:

• Pregnant females
• bleeding disorder
• history of pulmonary or systemic tuberculosis

Sponsors & Collaborators

• Sairah Sadaf: lead

Study Sites (1)

Sheikh Zayed Medical College

Rahim Yar Khan, Punjab Province, 64200, Pakistan

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 Officials

• sairah sadaf, fcps

  sheikh zayed medical college rhaim yar khan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Classified Consultant

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 23, 2024
• Study Start: November 1, 2022
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)