Video-assisted Anal Fistula Treatment Versus Seton in the Management of High Peri Anal Fistula

February 18, 2021 updated by: Dr. SamiUllah

Outcomes in High Perianal Fistula Repair Using Video-assisted Anal Fistula Treatment Compared With Seton Use: a Randomized Controlled Trial

Anal fistula is the most common Peri anal disease. It's a disease with an incidence of 9 in 100,000. Anal fistula is classified on the basis of its location into high and low anal fistula, above or below dentate line respectively.

Multiple series have shown that the formation of a fistula tract following anorectal abscess occurs in 7-40% of cases. There are typically 8-10 anal crypt glands at the level of the dentate line in the anal canal arranged circumstantially. These glands afford a path for infecting organisms to reach the intramuscular spaces. The cryptoglandular hypothesis states that an infection begins in the anal canal glands and progresses into the muscular wall of the anal sphincters to cause an anorectal abscess.

According to internal opening many author proposed certain classification but the standardized in all of them is Park's classification, so this study categorized the patient through this classification. There are four types of fistula-in-ano in Park's Classification intersphincteric (between internal and external sphincters is 70%), transsphincteric (across external sphincters is 25%), suprasphincteric (over sphincters), and extrasphincteric(above and through levator ani).High anal fistula is considered to be difficult to treat because of its location.This study diagnosed the internal opening of high perianal with the help of endoluminal ultrasound and MRI.

Classic method of its treatment are fistulotomy, fistulectomy and Setone placement but these are associated with lots of complication like fecal incontinence,recurrence,pain.Therefore many method have been recently devised including Ligation of intersphincteric fistula tract (Lift), glue repair and flap advancement.Another recently introduced method for its treatment is Video-assisted anal fistula treatment (VAAFT) proposed by P. Meinero which has been associated with less complications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 56 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients of either gender with age ranging from 15 to 60 years.
  2. All patients with high anal fistula

Exclusion Criteria:

  1. Patients with suspected malignancy determined by the presence of a mass on digital rectal examination,
  2. History of previous perianal surgery,
  3. History of irritable bowel disease determined by medical record
  4. Uncontrolled diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: SETON
Silk suture will be used as SETON
Procedure: SETON
In seton treatment, initially Hydrogen peroxide will be applied to the external opening with a 10-cc syringe, and the internal opening will be located by direct visualization of the anal canal via proctoscope. A probe will be inserted into the external opening and carefully maneuvered through the internal opening. Silk 1/0 suture will be then tied to the tip of the probe, which will be then squeezed out of the external opening. The suture will be then tied around the sphincter and through fistula tract. Later, the seton will be tightened at four-week intervals under local anesthesia until the suture cut through the sphincter.
Experimental: VAAFT
Video assisted anal fistula treatment
Procedure: VAAFT
Patients assigned to the VAAFT group will receive the following procedure. The external opening will be widened with a probe, and a fistulascope will be inserted to delineate the primary and secondary tracts and locate the internal opening. The internal opening will be then stitched with Vicryl™ (Polyglactin 910) 2-0 suture through the anal route with the help of a proctoscope. The tract of the fistula will be washed and debrided through the scope and cauterized. Finally, the external opening will be excised and will be sent for biopsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Recurrence of Disease or Fistula
Time Frame: 3 years postoperatively
Number of Participants with Recurrence of Disease or Fistula 3 Years After Treatment
3 years postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Surgery
Time Frame: Time from beginning of surgery to end of surgery,assessed up to 180 minutes
Duration of surgery measured upto 180 minutes
Time from beginning of surgery to end of surgery,assessed up to 180 minutes
Pain Score
Time Frame: 12 hours after surgery
Pain score measured through visual analog score with 1 being minimum and 10 being maximum. Lesser value represents better outcome and greater value shows worse outcome.
12 hours after surgery
Time to Return to Work
Time Frame: up to 4 weeks
up to 4 weeks
Time to Healing of Fistula
Time Frame: up to 12 weeks
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. SamiUllah

Investigators

  • Study Director: Mahmood Ayyaz, FCPS FACS, Professor of Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

August 28, 2014

First Submitted That Met QC Criteria

December 7, 2014

First Posted (Estimate)

December 10, 2014

Study Record Updates

Last Update Posted (Actual)

March 11, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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