Post Operative Pain, Recurrence
Conditions
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.
Interventions
PROCEDURESETON
In seton treatment, initially Hydrogen peroxide will be applied to the external opening with a 10-cc syringe, and the internal opening will be located by direct visualization of the anal canal via proctoscope. A probe will be inserted into the external opening and carefully maneuvered through the internal opening. Silk 1/0 suture will be then tied to the tip of the probe, which will be then squeezed out of the external opening. The suture will be then tied around the sphincter and through fistula tract. Later, the seton will be tightened at four-week intervals under local anesthesia until the suture cut through the sphincter.
PROCEDUREVAAFT
Patients assigned to the VAAFT group will receive the following procedure. The external opening will be widened with a probe, and a fistulascope will be inserted to delineate the primary and secondary tracts and locate the internal opening. The internal opening will be then stitched with Vicryl™ (Polyglactin 910) 2-0 suture through the anal route with the help of a proctoscope. The tract of the fistula will be washed and debrided through the scope and cauterized. Finally, the external opening will be excised and will be sent for biopsy.
Sponsors
Dr. SamiUllah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 60 Years
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Time to Return to Work | up to 4 weeks | — |
| Time to Healing of Fistula | up to 12 weeks | — |
Countries
Pakistan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SETON Hydrogen peroxide was injected to the external opening with a 10-cc syringe, and the internal opening was located by direct visualization of the anal canal via proctoscope. A cannulating probe was inserted into the external opening and carefully maneuvered through the internal opening. Silk 1/0 suture was then tied to the tip of the probe, which was then squeezed out of the external opening. The suture was then tied around the sphincter and through fistula tract, Later, the seton was tightened at four week interval under spinal anesthesia until the suture cut through the sphincter. | 40 |
| VAAFT The external opening was widened with a probe, and a fistulascope was inserted to delineate the primary and secondary tracts and locate the internal opening. The internal opening was then stitched with Vicryl™(Polyglactin 910) 2-0 suture through the anal route with the help of a proctoscope. And the tract of the fistula was washed and debrided through scope and it was coagulated with cautry so that tract be closed. | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | VAAFT | Total | SETON |
|---|---|---|---|
| Age, Continuous | 39.9 Years STANDARD_DEVIATION 12.4 | 39.1 Years STANDARD_DEVIATION 11.2 | 38.4 Years STANDARD_DEVIATION 10.1 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Pakistan | 40 participants | 80 participants | 40 participants |
| Sex: Female, Male Female | 33 Participants | 64 Participants | 31 Participants |
| Sex: Female, Male Male | 7 Participants | 16 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Number of Participants With Recurrence of Disease or Fistula
Number of Participants with Recurrence of Disease or Fistula 3 Years After Treatment
Time frame: 3 years postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SETON | Number of Participants With Recurrence of Disease or Fistula | 5 Participants |
| VAAFT | Number of Participants With Recurrence of Disease or Fistula | 10 Participants |
Secondary
Duration of Surgery
Duration of surgery measured upto 180 minutes
Time frame: Time from beginning of surgery to end of surgery,assessed up to 180 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SETON | Duration of Surgery | 36.97 Minutes | Standard Deviation 12.98 |
| VAAFT | Duration of Surgery | 78.60 Minutes | Standard Deviation 26.24 |
Secondary
Pain Score
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.
Time frame: 12 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SETON | Pain Score | 2.82 score on a scale | Standard Deviation 1.58 |
| VAAFT | Pain Score | 4.22 score on a scale | Standard Deviation 1.83 |
Secondary
Time to Healing of Fistula
Time frame: up to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SETON | Time to Healing of Fistula | 9.7 weeks | Standard Deviation 1.87 |
| VAAFT | Time to Healing of Fistula | 5.75 weeks | Standard Deviation 1.17 |
Secondary
Time to Return to Work
Time frame: up to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SETON | Time to Return to Work | 9.27 Days | Standard Deviation 2.06 |
| VAAFT | Time to Return to Work | 7.42 Days | Standard Deviation 1.78 |