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Completed

NCT Number: NCT06212739

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

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

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Key information

Conditions

Fistula in Ano Digestive System Diseases Digestive System Fistula Fistula Gastrointestinal Diseases Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LASER

Procedure

Diode laser used to effect closure of the anal fistula tract

Other names: FiLAC

LIFT

Procedure

The intersphincteric portion of the fistula is excised and ligated.

Other names: Ligation of the Intersphincteric Fistula Tract

Primary outcomes

  1. 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

  1. Operative time

    Time frame: Intraoperative

    Median operative time was to compare the two arms

  2. Continence

    Time frame: 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.

  3. SF36

    Time frame: 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.

  4. Return to work

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

    Days until return to work

  5. Duration of analgesia use

    Time frame: 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

  6. Failure rate

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study 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)

Acronym: LASERLIFT

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jan 19, 2024
Registry last updated
Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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