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

F

Fatih Sultan Mehmet Training and Research Hospital

Status

Completed

Conditions

Anal Fistula

Treatments

Procedure: steam ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT04811105
ANIL ERGIN...

Details and patient eligibility

About

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.

Full 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 .

Enrollment

16 patients

Sex

Male

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • All rats which have iatrogenic perianal fistula tract.

Exclusion criteria

  • Death of rat

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

16 participants in 2 patient groups

steam ablation
Active Comparator group
Description:
The fistula tract which treated with steam ablation
Treatment:
Procedure: steam ablation
control group
Active Comparator group
Description:
The fistula tract which do not take any treatment
Treatment:
Procedure: steam ablation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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