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Video-assisted Anal Fistula Treatment Versus Seton in the Management of High Peri Anal Fistula
NA trial testing SETON in Post Operative Pain in 80 participants. Completed in 31 July 2020.
| Lead sponsor | Dr. SamiUllah |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 August 2014 |
| Primary completion | 31 July 2020 |
| Estimated completion | 31 July 2020 |
| Sites | 1 location across Pakistan |
Dr. SamiUllah
Adults 15 to 60, any sex, with Post Operative Pain or Recurrence. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants with Recurrence of Disease or Fistula 3 Years After Treatment
| Group | Value | 95% CI |
|---|---|---|
| SETON | 5 | |
| VAAFT | 10 |
Duration of surgery measured upto 180 minutes
| Group | Value | 95% CI |
|---|---|---|
| SETON | 36.97 | ± 12.98 |
| VAAFT | 78.60 | ± 26.24 |
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.
| Group | Value | 95% CI |
|---|---|---|
| SETON | 2.82 | ± 1.58 |
| VAAFT | 4.22 | ± 1.83 |
| Group | Value | 95% CI |
|---|---|---|
| SETON | 9.27 | ± 2.06 |
| VAAFT | 7.42 | ± 1.78 |
| Group | Value | 95% CI |
|---|---|---|
| SETON | 9.7 | ± 1.87 |
| VAAFT | 5.75 | ± 1.17 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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