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

Fistula in Ano Clinical Trial

Official title:

a Comparison of the Recurrence of Fistula in Ano After Video Assisted Fistulectomy VS. Loose Seton in Surgical Patients Having Fistula in Ano

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06380036
• Other study ID #: 003AEstb/EC/01/2022
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: April 2024
• Source: Sheikh Zayed Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

1. 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

2. Exclusion Criteria:

• Pregnant females

• bleeding disorder

• history of pulmonary or systemic tuberculosis

Related Conditions & MeSH terms

• Fistula
• Fistula in Ano
• Rectal Fistula
• Recurrence

Intervention

Procedure:
• video assisted fistula tract surgery
in one group pt recieved VAAFTS

Locations

Country	Name	City	State
Pakistan	Sheikh Zayed Medical College	Rahim yar khan	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Sairah Sadaf

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence	to see whether recurrence occur or not	one year