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

S

Sairah Sadaf

Status

Completed

Conditions

Fistula in Ano

Treatments

Procedure: video assisted fistula tract surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT06380036
003AEstb/EC/01/2022

Details and patient eligibility

About

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

Full 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).

Enrollment

80 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

seton
Experimental group
Description:
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.
Treatment:
Procedure: video assisted fistula tract surgery
VAAFTS
Experimental group
Description:
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
Treatment:
Procedure: video assisted fistula tract surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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