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

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)

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

Study Overview

• Status: Completed
• Conditions: Fistula in Ano
• Intervention / Treatment: Procedure: Laser; Procedure: LIFT

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Federal Territory
    • Kuala Lumpur, Federal Territory, Malaysia, 59100
      • University Malaya Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser; Patients treated using fistula laser closure.	Procedure: Laser; Diode laser used to effect closure of the anal fistula tract; Other Names: FiLAC
Active Comparator: LIFT; Patients treated using ligation of intersphincteric fistula tract.	Procedure: LIFT; The intersphincteric portion of the fistula is excised and ligated.; Other Names: Ligation of the Intersphincteric Fistula Tract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain score	Post-operative pain will be assessed by a blinded assessor using the Visual Analogue Scale (VAS), a validated pain score.	6 hours, 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Median operative time was to compare the two arms	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.	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.	At baseline, and at 1 week, 1 month and 6 months post-operatively
Return to work	Days until return to work	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	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	6 months

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Principal Investigator: April C Roslani, MS, FACS, Universiti Malaya

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): August 2, 2021

Study Registration Dates

• First Submitted: December 25, 2023
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Estimated): January 19, 2024

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Rectal Fistula
• Other Study ID Numbers: MREC 201892-6637

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No