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

Primary Purpose

Post Operative Pain, Recurrence

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
SETON
VAAFT
Sponsored by
Dr. SamiUllah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

SETON

VAAFT

Arm Description

Silk suture will be used as SETON

Video assisted anal fistula treatment

Outcomes

Primary Outcome Measures

Number of Participants With Recurrence of Disease or Fistula
Number of Participants with Recurrence of Disease or Fistula 3 Years After Treatment

Secondary Outcome Measures

Duration of Surgery
Duration of surgery measured upto 180 minutes
Pain Score
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.
Time to Return to Work
Time to Healing of Fistula

Full Information

First Posted
August 28, 2014
Last Updated
February 18, 2021
Sponsor
Dr. SamiUllah
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1. Study Identification

Unique Protocol Identification Number
NCT02313597
Brief Title
Video-assisted Anal Fistula Treatment Versus Seton in the Management of High Peri Anal Fistula
Official Title
Outcomes in High Perianal Fistula Repair Using Video-assisted Anal Fistula Treatment Compared With Seton Use: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2014 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. SamiUllah

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SETON
Arm Type
Placebo Comparator
Arm Description
Silk suture will be used as SETON
Arm Title
VAAFT
Arm Type
Experimental
Arm Description
Video assisted anal fistula treatment
Intervention Type
Procedure
Intervention Name(s)
SETON
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
VAAFT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Recurrence of Disease or Fistula
Description
Number of Participants with Recurrence of Disease or Fistula 3 Years After Treatment
Time Frame
3 years postoperatively
Secondary Outcome Measure Information:
Title
Duration of Surgery
Description
Duration of surgery measured upto 180 minutes
Time Frame
Time from beginning of surgery to end of surgery,assessed up to 180 minutes
Title
Pain Score
Description
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.
Time Frame
12 hours after surgery
Title
Time to Return to Work
Time Frame
up to 4 weeks
Title
Time to Healing of Fistula
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients of either gender with age ranging from 15 to 60 years. All patients with high anal fistula Exclusion Criteria: Patients with suspected malignancy determined by the presence of a mass on digital rectal examination, History of previous perianal surgery, History of irritable bowel disease determined by medical record Uncontrolled diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmood Ayyaz, FCPS FACS
Organizational Affiliation
Professor of Surgery
Official's Role
Study Director
Facility Information:
Facility Name
Hospitals
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

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

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