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INVESTIGATION OF THE EFFICACY OF FISTULA OBLITERATION BY STEAM ABLATION IN PERİANAL FISTULAS (STEAM)

Primary Purpose

Anal Fistula

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
steam ablation
Sponsored by
Fatih Sultan Mehmet Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Fistula focused on measuring anal fistula, steam ablation, rat

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • All rats which have iatrogenic perianal fistula tract.

Exclusion Criteria:

  • Death of rat

Sites / Locations

  • Yeditepe University Medical School Experimental Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

steam ablation

control group

Arm Description

The fistula tract which treated with steam ablation

The fistula tract which do not take any treatment

Outcomes

Primary Outcome Measures

Effect of steam ablation treatment in perianal fistula in rats.
In the present study, we evaluated the effectiveness of steam ablation , associated or not to seton in the treatment of anal fistula surgically produced in rats. Although still very limited number of publications, the use of steam ablation in the treatment of anal fistula has shown promise, which was also observed in this study. There was a statistically significant difference when comparing the group treated with steam ablation and the control group. The previous seton placement not shown in this research any advantage, perhaps by allowing in some.

Secondary Outcome Measures

Full Information

First Posted
November 27, 2018
Last Updated
March 19, 2021
Sponsor
Fatih Sultan Mehmet Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04811105
Brief Title
INVESTIGATION OF THE EFFICACY OF FISTULA OBLITERATION BY STEAM ABLATION IN PERİANAL FISTULAS
Acronym
STEAM
Official Title
OBLITERATION OF THE PERIANAL FISTULA TRACT BY STEAM ABLATION DEVICE IN THE TREATMENT OF PERIANAL FISTULA CAN BE USED AS A TREATMENT OPTION , A RAT STUDY
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 10, 2018 (Actual)
Primary Completion Date
January 10, 2019 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fatih Sultan Mehmet Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Perianal fistula(PF) is one of the most frequent disease in anorectal disease.The incidence of PF is 8,6 -10 / 100 000 . The first surgical treatment is defined by Hippocrates in PF .This surgical treatment which found by Hippocrates , involves seton insertion into the tract of fistula . Today most of surgeon still use the same technic but PF is really hard disease to treat. Recurrence rate of PF is really high and there are lots of complication about this disease. The most scary complication during the surgery or postoperatively is anal disfunction. ın PF surgical technics involves ;fistulectomy (coring out), lay open (fistulotomy), Ligation of Intersphincteric Fistula Tract, advancement flap and laser ablation of the fistula tract . The popularity of laser ablation of the fistula tract is increasing day by day.This surgical procedure is applied with the laser device which use in varicose vain ablation in vascular surgery.In this study the investigator are trying to find out the effect of steam ablation in PF on rats.
Detailed Description
Perianal fistula(PF) is one of the most frequent disease in anorectal disease..This surgical treatment which found by Hippocrates , involves seton insertion into the tract of fistula . Todaymost of surgeon still use the same technic but PF is really hard disease to treat. Recurrence rate of PF is really high and there are lots of complication about this disease. The most scary complication during the surgery or postoperatively is anal disfunction. ın PF surgical technics involves ;fistulectomy (coring out), lay open (fistulotomy), Ligation of Intersphincteric Fistula Tract), advancement flap and laser ablation of the fistula tract . The popularity of laser ablation of the fistula tract is increasing day by day.This surgical procedure is applied with the laser device which use in varicose vain ablation in vascular surgery.In this study the investigator are trying to find out the effect of steam ablation in PF on rats.This new procedure has to be tried on rat firstly and the studies is very important which tried on rats. Our research includes 32 rats and Firstly the investigator created perianal fistula tract with 2.0 silk suture material on 3 o'clock in perianal region.1 month will wait for the maturation of fistula tract. After that the suture materials removed from the fistula tract and one fistula tract will treat with steam ablation device (3 o'clock )in 16 rats and the other 16 rats will be the control group .1 month will be wait for the examination of treatment of fistula tract in steam ablation group.Evaluation of fistula tract will define with microscopic examination after the excision.End of the study the investigator will be find out the effect of steam ablation on perianal fistula .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistula
Keywords
anal fistula, steam ablation, rat

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
32 rats have 1 fistula tract 16 rats will treat with steam ablation 16 rats will be control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
steam ablation
Arm Type
Active Comparator
Arm Description
The fistula tract which treated with steam ablation
Arm Title
control group
Arm Type
Active Comparator
Arm Description
The fistula tract which do not take any treatment
Intervention Type
Procedure
Intervention Name(s)
steam ablation
Other Intervention Name(s)
perianal fistül treatment with steam ablation device
Intervention Description
32 rats have 1 fistula tract .For 16 rats the investigator will use steam ablation to obliterate and 16 rats will be control group
Primary Outcome Measure Information:
Title
Effect of steam ablation treatment in perianal fistula in rats.
Description
In the present study, we evaluated the effectiveness of steam ablation , associated or not to seton in the treatment of anal fistula surgically produced in rats. Although still very limited number of publications, the use of steam ablation in the treatment of anal fistula has shown promise, which was also observed in this study. There was a statistically significant difference when comparing the group treated with steam ablation and the control group. The previous seton placement not shown in this research any advantage, perhaps by allowing in some.
Time Frame
7 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Perianal fistula is more frequent in male than woman nearly 8:1. So we have chosen the male rats
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All rats which have iatrogenic perianal fistula tract. Exclusion Criteria: Death of rat
Facility Information:
Facility Name
Yeditepe University Medical School Experimental Research Center
City
Istanbul
ZIP/Postal Code
34734
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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INVESTIGATION OF THE EFFICACY OF FISTULA OBLITERATION BY STEAM ABLATION IN PERİANAL FISTULAS

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