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

Not Applicable

Completed

• Conditions: Fistula in Ano
• Interventions: Procedure: Laser; Procedure: LIFT

• Registration Number: NCT06212739
• Lead Sponsor: University of Malaya

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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-08-02
• Status Verified: 2023-12
• Study First Submitted: 2023-12-25
• Study First Submitted QC: 2024-01-08
• Last Update Submitted: 2024-01-08
• Study First Posted: 2024-01-19
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser	Laser	Patients treated using fistula laser closure.
LIFT	LIFT	Patients treated using ligation of intersphincteric fistula tract.

Primary Outcome Measures

Name	Time	Method
Post-operative pain score	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 Outcome Measures

Name	Time	Method
Continence	At baseline, and at 1 week, 1 month and 6 months post-operatively	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.
Failure rate	6 months	Failure to heal was defined as failure of fistula closure (persistent discharge) beyond 6 months' post-operatively
Operative time	Intraoperative	Median operative time was to compare the two arms
Return to work	Number of days taken to return to work, assessed at 6 months post-operatively	Days until return to work
SF36	At baseline, and at 1 week, 1 month and 6 months post-operatively	The SF36 was used to assess pre- and post-operative quality of life.
Duration of analgesia use	Number of days until cessation of analgesia use, assessed at 1 week or 1 month, whichever is shorter	The duration in days that the patient needed to use analgesia post-operative

Trial Locations

Locations (1)

University Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Federal Territory, Malaysia