Comparison of Post-operative Pain Between Fistula Laser Closure and Ligation of the Intersphincteric Tract in the Treatment of Anal Fistula - a Randomized Controlled Trial. (LASERLIFT)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Fistula in Ano
- Sponsor
- University of Malaya
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Post-operative pain score
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Post-operative pain score
Time Frame: 6 hours, 24 hours
Post-operative pain will be assessed by a blinded assessor using the Visual Analogue Scale (VAS), a validated pain score.
Secondary Outcomes
- Continence(At baseline, and at 1 week, 1 month and 6 months post-operatively)
- Failure rate(6 months)
- Operative time(Intraoperative)
- Return to work(Number of days taken to return to work, assessed at 6 months post-operatively)
- SF36(At baseline, and at 1 week, 1 month and 6 months post-operatively)
- Duration of analgesia use(Number of days until cessation of analgesia use, assessed at 1 week or 1 month, whichever is shorter)