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

Fistula in Ano Clinical Trial

— LASERLIFT  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06212739
• Other study ID #: MREC 201892-6637
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: August 2, 2021

Study information

• Verified date: December 2023
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 2, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Fistula in Ano
• Rectal Fistula

Intervention

Procedure:
• Laser
Diode laser used to effect closure of the anal fistula tract
• LIFT
The intersphincteric portion of the fistula is excised and ligated.

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Centre	Kuala Lumpur	Federal Territory

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Operative time	Median operative time was to compare the two arms	Intraoperative
Secondary	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
Secondary	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
Secondary	Return to work	Days until return to work	Number of days taken to return to work, assessed at 6 months post-operatively
Secondary	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
Secondary	Failure rate	Failure to heal was defined as failure of fistula closure (persistent discharge) beyond 6 months' post-operatively	6 months