Clinical trial NCT02313597: 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
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Recurrence
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
First posted: 2014-12-10
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Recurrence of Disease or Fistula
timeFrame: 3 years postoperatively
Secondary outcomes:
measure: Duration of Surgery
timeFrame: Time from beginning of surgery to end of surgery,assessed up to 180 minutes
measure: Pain Score
timeFrame: 12 hours after surgery
measure: Time to Return to Work
timeFrame: up to 4 weeks
measure: Time to Healing of Fistula
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Hospitals
state: Punjab
Study officials:
affiliation: Professor of Surgery
name: Mahmood Ayyaz, FCPS FACS
role: STUDY_DIRECTOR
References: