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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SETON | Placebo Comparator | Silk suture will be used as SETON |
|
| VAAFT | Experimental | Video assisted anal fistula treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SETON | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Recurrence of Disease or Fistula | Number of Participants with Recurrence of Disease or Fistula 3 Years After Treatment | 3 years postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Surgery | Duration of surgery measured upto 180 minutes | Time from beginning of surgery to end of surgery,assessed up to 180 minutes |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mahmood Ayyaz, FCPS FACS | Professor of Surgery | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospitals | Lahore | Punjab Province | 54000 | Pakistan |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Recurrence of Disease or Fistula | Number of Participants with Recurrence of Disease or Fistula 3 Years After Treatment | Posted | Count of Participants | Participants | 3 years postoperatively |
|
up to 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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One of the limitations of our study is that it is single center study and results cannot be generalized, another thing is that we did not inject glue after doing VAAFT into remaining tract (as advised by Monre who is the inventor of this procedure) and we do not know whether this injection of glue can affect recurrence of fistula or not.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr, Shabbar Hussain Changazi | Services Institute of Medical Sciences | 923059700111 | shabbarchangazi246@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2014 | Nov 28, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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|
| VAAFT | Procedure | 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. |
|
| 12 hours after surgery |
| Time to Return to Work | up to 4 weeks |
| Time to Healing of Fistula | up to 12 weeks |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. |
|
|
| Secondary | Duration of Surgery | Duration of surgery measured upto 180 minutes | Posted | Mean | Standard Deviation | Minutes | Time from beginning of surgery to end of surgery,assessed up to 180 minutes |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 12 hours after surgery |
|
|
|
| Secondary | Time to Return to Work | Posted | Mean | Standard Deviation | Days | up to 4 weeks |
|
|
|
| Secondary | Time to Healing of Fistula | Posted | Mean | Standard Deviation | weeks | up to 12 weeks |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | 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. | 0 | 40 | 0 | 40 | 0 | 40 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D020969 | Disease Attributes |