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

NCT ID: NCT06380036

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-10-31

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

Detailed Description

Patients were equally allocated into two groups i.e. Group A & Group B by lottery method. In both groups, the lower bowel was emptied by an enema about an hour before the operation. 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.

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. The patients were discharged the day following the procedure. 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. The information (age, gender, duration of disease, BMI, diabetes mellitus, hypertension, place of living, and recurrence) was collected through pre-designed Performa (Annexure I).

Conditions

Fistula in Ano

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

seton

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.

Group Type: EXPERIMENTAL

video assisted fistula tract surgery

Intervention Type: PROCEDURE

in one group pt recieved VAAFTS

VAAFTS

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

Group Type: EXPERIMENTAL

video assisted fistula tract surgery

Intervention Type: PROCEDURE

in one group pt recieved VAAFTS

Interventions

video assisted fistula tract surgery

in one group pt recieved VAAFTS

Intervention Type: PROCEDURE

Other Intervention Names

Loose setone

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sairah Sadaf

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sairah Sadaf

Classified Consultant

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

sairah sadaf, fcps

Role: PRINCIPAL_INVESTIGATOR

sheikh zayed medical college rhaim yar khan

Locations

Sheikh Zayed Medical College

Rahim Yar Khan, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

003AEstb/EC/01/2022

Identifier Type: -

Identifier Source: org_study_id