Treatment of Anal Fistula With Lasercoagulation

Anal Fistula Clinical Trial

Official title:

Treatment of Anal Fistula With Laser Mediated Heat Coagulation Using Fistula Laser Closure (FiLaC)

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03017898
• Other study ID #: FiLaC-2016
• Status: Suspended
• Phase: N/A
• Start date: March 3, 2017
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 52
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Fistula-In-Ano
• Rectal Fistula

Intervention

Procedure:
• Laser Coagulation
Laser coagulation of anal fistula

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Malmo

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 months
Secondary	Infection	Rate of infection i.e. formation of abcess during the time of healing or thereafter within the first year of treatment.	12 months
Secondary	Incontinence	Presence of fecal incontinence as described by the patient	12 months