Clinical trial NCT03017898: Treatment of Anal Fistula With Lasercoagulation
Official title: Treatment of Anal Fistula With Laser Mediated Heat Coagulation Using Fistula Laser Closure (FiLaC)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Fistula-In-Ano
Anal Fistula
Keywords: FiLaC
Fistula Laser Closure
Laser Coagulation
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Healing
timeFrame: 12 months
Secondary outcomes:
measure: Infection
timeFrame: 12 months
measure: Incontinence
timeFrame: 12 months
Other outcomes:
Locations:
city: Malmo
country: Sweden
facility: Skåne University Hospital
Study officials:
References:
citation: Wilhelm A. A new technique for sphincter-preserving anal fistula repair using a novel radial emitting laser probe. Tech Coloproctol. 2011 Dec;15(4):445-9. doi: 10.1007/s10151-011-0726-0. Epub 2011 Aug 16.
citation: Giamundo P, Esercizio L, Geraci M, Tibaldi L, Valente M. Fistula-tract Laser Closure (FiLaC): long-term results and new operative strategies. Tech Coloproctol. 2015 Aug;19(8):449-53. doi: 10.1007/s10151-015-1282-9. Epub 2015 Feb 28.
citation: Giamundo P, Geraci M, Tibaldi L, Valente M. Closure of fistula-in-ano with laser--FiLaC: an effective novel sphincter-saving procedure for complex disease. Colorectal Dis. 2014 Feb;16(2):110-5. doi: 10.1111/codi.12440.
citation: Ozturk E, Gulcu B. Laser ablation of fistula tract: a sphincter-preserving method for treating fistula-in-ano. Dis Colon Rectum. 2014 Mar;57(3):360-4. doi: 10.1097/DCR.0000000000000067.