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

NCT02313597 | Completed Results

• 1 other identifier: V1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain; Recurrence

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Recurrence of Disease or Fistula

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

  3 years postoperatively

Secondary Outcomes (4)

• Duration of Surgery

  Time from beginning of surgery to end of surgery,assessed up to 180 minutes

• Pain Score

  12 hours after surgery

• Time to Return to Work

  up to 4 weeks

• Time to Healing of Fistula

  up to 12 weeks

Study Arms (2)

SETON

PLACEBO COMPARATOR

Silk suture will be used as SETON

Procedure: SETON

VAAFT

EXPERIMENTAL

Video assisted anal fistula treatment

Procedure: VAAFT

Interventions

SETON PROCEDURE

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.

SETON

VAAFT PROCEDURE

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.

VAAFT

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. SamiUllah: lead

Study Sites (1)

Hospitals

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative; Recurrence

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Disease Attributes

Limitations and Caveats

One of the limitations of our study is that it is single center study and results cannot be generalized, another thing is that we did not inject glue after doing VAAFT into remaining tract (as advised by Monre who is the inventor of this procedure) and we do not know whether this injection of glue can affect recurrence of fistula or not.

Results Point of Contact

• Title: Dr, Shabbar Hussain Changazi
• Organization: Services Institute of Medical Sciences

shabbarchangazi246@gmail.com

923059700111

Study Officials

• Mahmood Ayyaz, FCPS FACS

  Professor of Surgery

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Officer

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: December 10, 2014
• Study Start: August 1, 2014
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: March 11, 2021
• Results First Posted: January 27, 2021

Record last verified: 2021-02

Locations

PA (1)