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N/A N=80 Randomized Single-blind Treatment

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

Post Operative Pain · Recurrence

Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Number of Participants With Recurrence of Disease or Fistula — 5; 10 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
SETON (Procedure); VAAFT (Procedure)
Age
Pediatric, Adult · 15+ yrs
Sex
All
Sponsor
Dr. SamiUllah
Primary completion
Jul 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Recurrence of Disease or Fistula
5; 10
SECONDARY
Duration of Surgery
36.97; 78.60
SECONDARY
Pain Score
2.82; 4.22
SECONDARY
Time to Return to Work
9.27; 7.42
SECONDARY
Time to Healing of Fistula
9.7; 5.75

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

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02313597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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