Post-op Pain After Fistula Laser Closure or Ligation of the Intersphincteric Tract for Anal Fistula (LASERLIFT)

University of Malaya

Status

Completed

Conditions

Fistula in Ano

Treatments

Procedure: Laser

Procedure: LIFT

Study type

Interventional

Funder types

Other

Identifiers

NCT06212739

MREC 201892-6637

Details and patient eligibility

About

This is a prospective, double-blinded randomised controlled trial conducted at two tertiary hospitals by a credentialed colorectal surgeon.

Full 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 were measured using the visual analogue scale (VAS). Operative time was measured in minutes Continence and quality of life was assessed via the Wexner incontinence scale and SF-36 questionnaire respectively at 0, 3 and 6 months post-operatively.

Enrollment

56 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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