Trials / Completed
CompletedNCT06212739
Post-op Pain After Fistula Laser Closure or Ligation of the Intersphincteric Tract for Anal Fistula
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)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- University of Malaya · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Laser | Diode laser used to effect closure of the anal fistula tract |
| PROCEDURE | LIFT | The intersphincteric portion of the fistula is excised and ligated. |
Timeline
- Start date
- 2018-01-01
- Primary completion
- 2020-12-31
- Completion
- 2021-08-02
- First posted
- 2024-01-19
- Last updated
- 2024-01-19
Locations
1 site across 1 country: Malaysia
Source: ClinicalTrials.gov record NCT06212739. Inclusion in this directory is not an endorsement.