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VAAFT Vs SETON in the Management of High Peri Anal Fistula

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02313597
Recruitment Status : Completed
First Posted : December 10, 2014
Last Update Posted : September 16, 2020
Information provided by (Responsible Party):
Dr. SamiUllah, Services Hospital, Lahore

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.

Condition or disease Intervention/treatment Phase
Post Operative Pain Recurrence Procedure: VAAFT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Post Operative Outcome of VAAFT vs SETON Tightening in the Management of High Perianal Fistula
Actual Study Start Date : August 2014
Actual Primary Completion Date : July 2020
Actual Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Placebo Comparator: SETON
Seton placement is a method of treatment for complex fistulas in which seton placement method is used.
Procedure: VAAFT
Video assisted Anal fistula Treatment is minimal invasive method of treatment of complex and high anal fistulas.

Experimental: VAAFT
Video assisted anal fistula treatment
Procedure: VAAFT
Video assisted Anal fistula Treatment is minimal invasive method of treatment of complex and high anal fistulas.

Primary Outcome Measures :
  1. recurrence of disease or fistula [ Time Frame: 3 years postoperatively ]
    recurrence of fistula will be noted 3 years after the treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 age less than 15 years and greater than 60
  2. Patients having co-morbid factors such as diabetes and ischemic heart disease
  3. patients having known malignant cause of fistula

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02313597

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Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
Dr. SamiUllah
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Study Director: Mahmood Ayyaz, FCPS FACS Professor of Surgery
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Responsible Party: Dr. SamiUllah, Medical Officer, Services Hospital, Lahore Identifier: NCT02313597    
Other Study ID Numbers: V1
First Posted: December 10, 2014    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Pain, Postoperative
Disease Attributes
Pathologic Processes
Pathological Conditions, Anatomical
Postoperative Complications
Neurologic Manifestations