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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-08-02

Brief Summary

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

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Detailed Description

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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

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Fistula in Ano

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Outcomes assessor was blinded to the intervention.

Study Groups

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Laser

Patients treated using fistula laser closure.

Group Type EXPERIMENTAL

Laser

Intervention Type PROCEDURE

Diode laser used to effect closure of the anal fistula tract

LIFT

Patients treated using ligation of intersphincteric fistula tract.

Group Type ACTIVE_COMPARATOR

LIFT

Intervention Type PROCEDURE

The intersphincteric portion of the fistula is excised and ligated.

Interventions

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Laser

Diode laser used to effect closure of the anal fistula tract

Intervention Type PROCEDURE

LIFT

The intersphincteric portion of the fistula is excised and ligated.

Intervention Type PROCEDURE

Other Intervention Names

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FiLAC Ligation of the Intersphincteric Fistula Tract

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No