Trial Outcomes & Findings for Video-assisted Anal Fistula Treatment Versus Seton in the Management of High Peri Anal Fistula (NCT NCT02313597)
NCT ID: NCT02313597
Last Updated: 2021-03-11
Results Overview
Number of Participants with Recurrence of Disease or Fistula 3 Years After Treatment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
3 years postoperatively
Results posted on
2021-03-11
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
SETON
n=40 Participants
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.
|
VAAFT
n=40 Participants
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
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.4 Years
STANDARD_DEVIATION 10.1 • n=40 Participants
|
39.9 Years
STANDARD_DEVIATION 12.4 • n=40 Participants
|
39.1 Years
STANDARD_DEVIATION 11.2 • n=80 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=40 Participants
|
33 Participants
n=40 Participants
|
64 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=40 Participants
|
7 Participants
n=40 Participants
|
16 Participants
n=80 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Pakistan
|
40 participants
n=40 Participants
|
40 participants
n=40 Participants
|
80 participants
n=80 Participants
|
PRIMARY outcome
Timeframe: 3 years postoperativelyNumber of Participants with Recurrence of Disease or Fistula 3 Years After Treatment
Outcome measures
| Measure |
SETON
n=40 Participants
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.
|
VAAFT
n=40 Participants
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.
|
|---|---|---|
|
Number of Participants With Recurrence of Disease or Fistula
|
5 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Time from beginning of surgery to end of surgery,assessed up to 180 minutesDuration of surgery measured upto 180 minutes
Outcome measures
| Measure |
SETON
n=40 Participants
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.
|
VAAFT
n=40 Participants
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.
|
|---|---|---|
|
Duration of Surgery
|
36.97 Minutes
Standard Deviation 12.98
|
78.60 Minutes
Standard Deviation 26.24
|
SECONDARY outcome
Timeframe: 12 hours after surgeryPain 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.
Outcome measures
| Measure |
SETON
n=40 Participants
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.
|
VAAFT
n=40 Participants
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.
|
|---|---|---|
|
Pain Score
|
2.82 score on a scale
Standard Deviation 1.58
|
4.22 score on a scale
Standard Deviation 1.83
|
SECONDARY outcome
Timeframe: up to 4 weeksOutcome measures
| Measure |
SETON
n=40 Participants
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.
|
VAAFT
n=40 Participants
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.
|
|---|---|---|
|
Time to Return to Work
|
9.27 Days
Standard Deviation 2.06
|
7.42 Days
Standard Deviation 1.78
|
SECONDARY outcome
Timeframe: up to 12 weeksOutcome measures
| Measure |
SETON
n=40 Participants
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.
|
VAAFT
n=40 Participants
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.
|
|---|---|---|
|
Time to Healing of Fistula
|
9.7 weeks
Standard Deviation 1.87
|
5.75 weeks
Standard Deviation 1.17
|
Adverse Events
SETON
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VAAFT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr, Shabbar Hussain Changazi
Services Institute of Medical Sciences
Phone: 923059700111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place