NCT06212739

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2021

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 25, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 19, 2024

Completed
Last Updated

January 19, 2024

Status Verified

December 1, 2023

Enrollment Period

3 years

First QC Date

December 25, 2023

Last Update Submit

January 8, 2024

Conditions

Fistula in Ano

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Operative time

    Intraoperative

  • Continence

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

  • SF36

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

  • Return to work

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

  • Duration of analgesia use

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

  • +1 more secondary outcomes

Study Arms (2)

Laser

EXPERIMENTAL

Patients treated using fistula laser closure.

Procedure: Laser

LIFT

ACTIVE COMPARATOR

Patients treated using ligation of intersphincteric fistula tract.

Procedure: LIFT

Interventions

LaserPROCEDURE

Diode laser used to effect closure of the anal fistula tract

Also known as: FiLAC
Laser
LIFTPROCEDURE

The intersphincteric portion of the fistula is excised and ligated.

Also known as: Ligation of the Intersphincteric Fistula Tract
LIFT

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Complex transphincteric fistulas:
  • high transphincteric fistula, involving more than 30% of the external anal sphincter
  • Multiple fistulas
  • Anterior fistulas
  • years old
  • Able to give consent
  • New or recurrent fistulas
  • Fistulas with or without setons

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Related Publications (1)

  • Low JQL, Rajandram R, Aziz MRA, Roslani AC. Postoperative pain following laser fistula closure versus ligation of the intersphincteric fistula tract: A prospective double-blinded randomized controlled trial. World J Surg. 2024 Aug;48(8):1990-1999. doi: 10.1002/wjs.12242. Epub 2024 Jun 6.

    PMID: 38844401DERIVED

MeSH Terms

Conditions

Rectal Fistula

Interventions

Lasers

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • April C Roslani, MS, FACS

    Universiti Malaya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessor was blinded to the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2023

First Posted

January 19, 2024

Study Start

January 1, 2018

Primary Completion

December 31, 2020

Study Completion

August 2, 2021

Last Updated

January 19, 2024

Record last verified: 2023-12

Locations

MY(1)