Clinical trial NCT06380036: Two Approaches to Lower the Chances of Recurrence of Anal Fistula After Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fistula in Ano
Lead sponsor: Sheikh Zayed Medical College
Sponsor class: OTHER_GOV
First posted: 2024-04-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: recurrence
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Rahim yar khan
country: Pakistan
facility: Sheikh Zayed Medical College
state: Punjab
Study officials:
affiliation: sheikh zayed medical college rhaim yar khan
name: sairah sadaf, fcps
role: PRINCIPAL_INVESTIGATOR
References: