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

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02313597
• Other study ID #: V1
• Status: Completed
• Phase: N/A
• Start date: August 1, 2014
• Est. completion date: July 31, 2020

Study information

• Verified date: February 2021
• Source: Services Hospital, Lahore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Pain, Postoperative
• Post Operative Pain
• Rectal Fistula
• Recurrence

Intervention

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.
• 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.

Locations

Country	Name	City	State
Pakistan	Hospitals	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Dr. SamiUllah

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of Surgery	Duration of surgery measured upto 180 minutes	Time from beginning of surgery to end of surgery,assessed up to 180 minutes
Secondary	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.	12 hours after surgery
Secondary	Time to Return to Work		up to 4 weeks
Secondary	Time to Healing of Fistula		up to 12 weeks