NCT04811105

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2018

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2019

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

November 27, 2018

Last Update Submit

March 19, 2021

Conditions

Anal Fistula

Keywords

anal fistulasteam ablationrat

Outcome Measures

Primary Outcomes (1)

  • 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.

    7 weeks

Study Arms (2)

steam ablation

ACTIVE COMPARATOR

The fistula tract which treated with steam ablation

Procedure: steam ablation

control group

ACTIVE COMPARATOR

The fistula tract which do not take any treatment

Procedure: steam ablation

Interventions

steam ablationPROCEDURE

32 rats have 1 fistula tract .For 16 rats the investigator will use steam ablation to obliterate and 16 rats will be control group

Also known as: perianal fistül treatment with steam ablation device
control groupsteam ablation

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility DetailsPerianal fistula is more frequent in male than woman nearly 8:1. So we have chosen the male rats
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All rats which have iatrogenic perianal fistula tract.

You may not qualify if:

  • Death of rat

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University Medical School Experimental Research Center

Istanbul, 34734, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 32 rats have 1 fistula tract 16 rats will treat with steam ablation 16 rats will be control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Dr , General Surgery , Principal Investigator,

Study Record Dates

First Submitted

November 27, 2018

First Posted

March 23, 2021

Study Start

November 10, 2018

Primary Completion

January 10, 2019

Study Completion

March 1, 2021

Last Updated

March 23, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)