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

Not Applicable
Completed
Conditions
Fistula in Ano
Interventions
Procedure: video assisted fistula tract surgery
Registration Number
NCT06380036
Lead Sponsor
Sairah Sadaf
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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
VAAFTSvideo assisted fistula tract surgeryIn 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
setonvideo assisted fistula tract surgeryloose 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.
Primary Outcome Measures
NameTimeMethod
recurrenceone year

to see whether recurrence occur or not

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Sheikh Zayed Medical College

🇵🇰

Rahim yar khan, Punjab, Pakistan

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