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

March 19, 2021 updated by: ANIL ERGIN, Fatih Sultan Mehmet Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34734
        • Yeditepe University Medical School Experimental Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • All rats which have iatrogenic perianal fistula tract.

Exclusion Criteria:

  • Death of rat

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: steam ablation
The fistula tract which treated with steam ablation
Procedure: steam ablation
32 rats have 1 fistula tract .For 16 rats the investigator will use steam ablation to obliterate and 16 rats will be control group
Other Names:
  • perianal fistül treatment with steam ablation device
Active Comparator: control group
The fistula tract which do not take any treatment
Procedure: steam ablation
32 rats have 1 fistula tract .For 16 rats the investigator will use steam ablation to obliterate and 16 rats will be control group
Other Names:
  • perianal fistül treatment with steam ablation device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of steam ablation treatment in perianal fistula in rats.
Time Frame: 7 weeks
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.
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatih Sultan Mehmet Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2018

Primary Completion (Actual)

January 10, 2019

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

November 27, 2018

First Submitted That Met QC Criteria

March 19, 2021

First Posted (Actual)

March 23, 2021

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 19, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANIL ERGIN...

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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