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Clinical Trials/CTRI/2024/04/065703
CTRI/2024/04/065703Not yet recruitingPhase 3 4

A Comparative Study Between Partial Fistulectomy with Ksharasutra Application and Interception of Fistula Track with Application of Ksharasutra (IFTAK) to Evaluate their Effect in the Management of Bhagandara w.s.r. to Complex Fistula-In-Ano

Principal R.G.G.P.G. Ayurvedic college and hospital Paprola1 site in 1 country30 target enrollmentStarted: April 25, 2024Last updated:
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Trial Snapshot

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
The present study aims to evaluate the outcome of both techniques Partial fistulectomy with K
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

In this study efficacy of an advanced, innovative & emerging, minimal invasive Ksharasutra technique named IFTAK (Interception of Fistula Tract with application of Ksharasutra) will be compared & evaluated with most commonly used  “Partial fistulectomy with Ksharasutra application” for knowing that which technique having more potency in better management of complex fistula in ano along with needful issues eg. post operative pain, anal function, duration of treatment and  scar mark*.*

Study Design

Study Type
Interventional
Allocation
Other
Masking
None

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •All type of complex fistula may be fresh/recurrent, had multiple tracks as well as horseshoe fistula.
  • •Patients who have given informed & written consent to participate in the trial.
  • •Patients between age group 20-60 years of age of either gender.

Exclusion Criteria

  • •a)Non cryptoglandular origin fistula-in-ano.
  • •b)Extrasphincteric, supralevator and translevator fistula.
  • •c)Patients below age of 20 yrs and above 60 yrs of age.
  • •d)Bleeding disorders.
  • •e)Existing continence disturbance.
  • •f)Uncontrolled diabetes mellitus & hypertension.
  • •g)Patient with malignancy, tuberculosis, COPD .
  • •h)ICTC, HBsAg positive case.

Outcomes

Primary Outcomes

The present study aims to evaluate the outcome of both techniques Partial fistulectomy with K

Time Frame: 6 Months

ksharasutra application and interception of fistula track with application of ksharasutra (IFTAK) in the management of bhagandara w.s.r. to complex fistula-in-ano”

Time Frame: 6 Months

Secondary Outcomes

  • To find out the best surgical technique for management of bhagandara among two techniques.(6 Months)

Investigators

Sponsor
Principal R.G.G.P.G. Ayurvedic college and hospital Paprola
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Prof Kulwant Singh Himaliyan

R.G.G.P.G. Ayurvedic College and Hospital Paprola, Kangra

Study Sites (1)

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