Status:
COMPLETED
Post-op Pain After Fistula Laser Closure or Ligation of the Intersphincteric Tract for Anal Fistula
Lead Sponsor:
University of Malaya
Conditions:
Fistula in Ano
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This is a prospective, double-blinded randomised controlled trial conducted at two tertiary hospitals by a credentialed colorectal surgeon.
Detailed Description
Patients with high transphincteric fistulas were blinded and randomized to either laser or ligation of the fistula tract (LIFT). Pain scores at rest and movement, at 6 and 24 hours post operatively we...
Eligibility Criteria
Inclusion
- Complex transphincteric fistulas:
- high transphincteric fistula, involving more than 30% of the external anal sphincter
- Multiple fistulas
- Anterior fistulas
- 18-75 years old
- Able to give consent
- New or recurrent fistulas
- Fistulas with or without setons
Exclusion
- Active perianal sepsis requiring drainage
- Fistulas of non-cryptogladular origin- Crohn's, TB, malignancy
- Expected lifespan less than 6 months
- Pregnant women
- Patients with more than 1 definitive surgery done for the fistula before
- Patients with human immunodeficiency virus infection
- Patients with pre-existing chronic pain disorders
- Patients with Non-steroidal Anti-inflammatory Drug (NSAIDS) / Paracetamol allergies
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2021
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06212739
Start Date
January 1 2018
End Date
August 2 2021
Last Update
January 19 2024
Active Locations (1)
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1
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia, 59100