Treatment of Anal Fistula With Lasercoagulation

Region Skane52 enrolled

Overview

The purpose of this study is to determine whether treatment with laser coagulation is an effective and safe treatment option for patients with anal fistula

Treatment of anal fistula remains a challenge - the only truly effective treatment available (fistulotomy) involves very high rates of anal incontinence if performed on the majority of patients, and a vast number of alternative, sphincter-preserving treatments have been developed and evaluated in the past decades. The treatment of anal fistula with laser coagulation causes the fistula to collapse and subsequently heal, without having to add any external materials. The available published studies show that the treatment is safe regarding infection and incontinence, and that a majority of the patients treated show complete healing. There is however a need for more prospective studies to ascertain these preliminary facts.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fistula-In-Ano Anal Fistula

Interventions

Laser CoagulationPROCEDURE

Laser coagulation of anal fistula

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent. 2. Subject must be at least 18 years of age 3. Subject must have a verified anal fistula (by transanal ultrasound performed by treating surgeon) 4. Subject must have a clean and infection-free fistula tract (no cavities seen on transanal ultrasound) 5. Subject must be able to comply with study and study follow-up requirements. Exclusion Criteria: 1. Subject with anorectal fistula due to Crohn's disease 2. Subject has an undrained abscess in fistula tract (cavities as seen on transanal ultrasound) 3. Subject has fistula with side tracts (as seen on transanal ultrasound) 4. Subject is unable or unwilling to provide informed consent.

Locations (1)

Skåne University Hospital

Malmo, Sweden

Outcomes

Primary Outcomes

Healing

Fistula closure success at 12 months is defined as complete healing of the fistula tract and external opening at clinical examination and on a transanal ultrasound performed by the examining surgeon (yes/no).

Time frame: 12 months

Secondary Outcomes

Infection

Rate of infection i.e. formation of abcess during the time of healing or thereafter within the first year of treatment.

Time frame: 12 months

Incontinence

Presence of fecal incontinence as described by the patient

Time frame: 12 months

Data from ClinicalTrials.gov

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