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

• Sponsor: Dr. SamiUllah (Other)
• Overall Status: Completed
• CT.gov ID: NCT02313597
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 72
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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: SETON; Procedure: VAAFT	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Outcomes in High Perianal Fistula Repair Using Video-assisted Anal Fistula Treatment Compared With Seton Use: a Randomized Controlled Trial
• Actual Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Jul 31, 2020
• Actual Study Completion Date: Jul 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: SETON Silk suture will be used as SETON	Procedure: SETON; 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.
Experimental: VAAFT Video assisted anal fistula treatment	Procedure: VAAFT; 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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Duration of Surgery [Time from beginning of surgery to end of surgery,assessed up to 180 minutes]

   Duration of surgery measured upto 180 minutes

2. 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.

3. Time to Return to Work [up to 4 weeks]

4. Time to Healing of Fistula [up to 12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 60 Years
• 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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospitals	Lahore	Punjab	Pakistan	54000

Sponsors and Collaborators

• Dr. SamiUllah

Investigators

• Study Director: Mahmood Ayyaz, FCPS FACS, Professor of Surgery

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 30, 2014

More Information

Publications

None provided.

• Responsible Party: Dr. SamiUllah, Medical Officer, Services Hospital, Lahore
• ClinicalTrials.gov Identifier: NCT02313597
• Other Study ID Numbers: V1
• First Posted: Dec 10, 2014
• Last Update Posted: Mar 11, 2021
• Last Verified: Feb 1, 2021

• Additional relevant MeSH terms: Rectal Fistula; Recurrence; Fistula; Pain, Postoperative

Study Results

Participant Flow

Arm/Group Title	SETON	VAAFT
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	40	40
COMPLETED	40	40
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	SETON	VAAFT	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	40	40	80
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	38.4 (10.1)	39.9 (12.4)	39.1 (11.2)
Sex: Female, Male (Count of Participants)
Female	31 77.5%	33 82.5%	64 80%
Male	9 22.5%	7 17.5%	16 20%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Pakistan	40 100%	40 100%	80 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Recurrence of Disease or Fistula
Description	Number of Participants with Recurrence of Disease or Fistula 3 Years After Treatment
Time Frame	3 years postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SETON	VAAFT
Arm/Group Description	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.	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.
Measure Participants	40	40
Count of Participants [Participants]	5 12.5%	10 25%

2. Secondary Outcome

Title	Duration of Surgery
Description	Duration of surgery measured upto 180 minutes
Time Frame	Time from beginning of surgery to end of surgery,assessed up to 180 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SETON	VAAFT
Arm/Group Description	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.	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.
Measure Participants	40	40
Mean (Standard Deviation) [Minutes]	36.97 (12.98)	78.60 (26.24)

3. Secondary Outcome

Title	Pain Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SETON	VAAFT
Arm/Group Description	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.	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.
Measure Participants	40	40
Mean (Standard Deviation) [score on a scale]	2.82 (1.58)	4.22 (1.83)

4. Secondary Outcome

Title	Time to Return to Work
Time Frame	up to 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SETON	VAAFT
Arm/Group Description	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.	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.
Measure Participants	40	40
Mean (Standard Deviation) [Days]	9.27 (2.06)	7.42 (1.78)

5. Secondary Outcome

Title	Time to Healing of Fistula
Time Frame	up to 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SETON	VAAFT
Arm/Group Description	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.	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.
Measure Participants	40	40
Mean (Standard Deviation) [weeks]	9.7 (1.87)	5.75 (1.17)

Adverse Events

Time Frame	up to 12 weeks
Arm/Group Title	SETON		VAAFT
Arm/Group Description	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.		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.
All Cause Mortality
	SETON		VAAFT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Serious Adverse Events
	SETON		VAAFT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	SETON		VAAFT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.