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

Not Applicable

Completed

Conditions: Recurrence
Post Operative Pain

Interventions: Procedure: VAAFT
Procedure: SETON

Registration Number: NCT02313597

Lead Sponsor: Dr. SamiUllah

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 80

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VAAFT	VAAFT	Video assisted anal fistula treatment
SETON	SETON	Silk suture will be used as SETON

Primary Outcome Measures

Name	Time	Method
Number of Participants With Recurrence of Disease or Fistula	3 years postoperatively	Number of Participants with Recurrence of Disease or Fistula 3 Years After Treatment

Secondary Outcome Measures

Name	Time	Method
Time to Healing of Fistula	up to 12 weeks
Time to Return to Work	up to 4 weeks
Duration of Surgery	Time from beginning of surgery to end of surgery,assessed up to 180 minutes	Duration of surgery measured upto 180 minutes
Pain Score	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.