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Completed

NCT Number: NCT06380036

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

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheikh Zayed Medical College

Rahim Yar Khan, Punjab Province, 64200, Pakistan

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

video assisted fistula tract surgery

Procedure

in one group pt recieved VAAFTS

Other names: Loose setone

Primary outcomes

  1. recurrence

    Time frame: one year

    to see whether recurrence occur or not

Sponsors and collaborators

Lead sponsor

Sairah Sadaf

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 23, 2024
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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