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

University of Malaya56 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Fistula in Ano

Interventions

LaserPROCEDURE

Diode laser used to effect closure of the anal fistula tract

LIFTPROCEDURE

The intersphincteric portion of the fistula is excised and ligated.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Outcomes

Primary Outcomes

Post-operative pain score

Post-operative pain will be assessed by a blinded assessor using the Visual Analogue Scale (VAS), a validated pain score.

Time frame: 6 hours, 24 hours

Secondary Outcomes

Operative time

Median operative time was to compare the two arms

Time frame: Intraoperative

Continence

The Wexner score was used to assess pre- and post-operative continence. Minimum score is 3, maximum score is 12. The lower the score, the worse the incontinence.

Time frame: At baseline, and at 1 week, 1 month and 6 months post-operatively

SF36

The SF36 was used to assess pre- and post-operative quality of life.

Time frame: At baseline, and at 1 week, 1 month and 6 months post-operatively

Return to work

Days until return to work

Time frame: Number of days taken to return to work, assessed at 6 months post-operatively

Duration of analgesia use

The duration in days that the patient needed to use analgesia post-operative

Time frame: Number of days until cessation of analgesia use, assessed at 1 week or 1 month, whichever is shorter

Failure rate

Failure to heal was defined as failure of fistula closure (persistent discharge) beyond 6 months' post-operatively

Time frame: 6 months

Data from ClinicalTrials.gov

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