Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06380036
Other study ID # 003AEstb/EC/01/2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Terminated NCT02423330 - A Prospective Evaluation of the Strattice-LIFT to Treat Anal Fistula Early Phase 1
Terminated NCT03381365 - Efficacy of an Anorectal Fistula Plug With Sealing of the Internal Opening as a Treatment for Perianal Fistula N/A
Suspended NCT04660903 - Treatment of Fistula in Ano With Autologous Fatty Tissue Cells Transplantation N/A
Recruiting NCT04187651 - PRP Use in Treatment of Fistula Ano N/A
Completed NCT04069728 - The Impact of 3D Anal Fistula Models on Patient Understanding and Decision Making N/A
Recruiting NCT05390151 - Laser Assisted Treatment of Fistula In Ano N/A
Recruiting NCT05039411 - Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas Patients With Crohn's Disease Phase 1
Completed NCT01880398 - Management of Fistula in Ano by Kshar Sutra, Para Surgical Procedure. N/A
Completed NCT03449069 - Pediatric MSC-AFP Sub-study for Crohn's Fistula Phase 1
Completed NCT04588701 - Long Term Outcomes After Surgery for Anal Fistula
Recruiting NCT05666609 - Fistula-in-ano in Infants and Children N/A
Completed NCT06212739 - Post-op Pain After Fistula Laser Closure or Ligation of the Intersphincteric Tract for Anal Fistula N/A
Completed NCT01954225 - Role of Udumbara Sutra in the Management of Fistula in Ano a Rare Case Study N/A
Completed NCT05223309 - High Type Fistula in Ano, Use Staged Seton, Loose Thick Sutures
Terminated NCT02686580 - Feasibility Study to Assess the Early Use of Porcine Cross-linked Collagen Paste in Cryptoglandular Anorectal Fistulas Phase 3
Completed NCT05660876 - Fistulotomy Versus Fistulotomy With Marsupialization N/A
Recruiting NCT04161469 - Laser Closure of Anal Fistula (FiLaC) N/A
Completed NCT04215718 - Fistulotomy With Marsupialization Versus Fistulectomy With Wound Sutures in Simple Anal Fistula N/A