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Treatment of Anal Fistula With Lasercoagulation

Primary Purpose

Fistula-In-Ano, Anal Fistula

Status

Suspended

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Laser Coagulation

About this trial

This is an interventional treatment trial for Fistula-In-Ano focused on measuring FiLaC, Fistula Laser Closure, Laser Coagulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
Subject must be at least 18 years of age
Subject must have a verified anal fistula (by transanal ultrasound performed by treating surgeon)
Subject must have a clean and infection-free fistula tract (no cavities seen on transanal ultrasound)
Subject must be able to comply with study and study follow-up requirements.

Exclusion Criteria:

Subject with anorectal fistula due to Crohn's disease
Subject has an undrained abscess in fistula tract (cavities as seen on transanal ultrasound)
Subject has fistula with side tracts (as seen on transanal ultrasound)
Subject is unable or unwilling to provide informed consent.

Sites / Locations

Skåne University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laser coagulation

Arm Description

Treatment of anal fistulae meeting the inclusion criteria

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Infection

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

Incontinence

Presence of fecal incontinence as described by the patient

Full Information

NCT ID

NCT03017898

First Posted

January 9, 2017

Last Updated

January 17, 2022

Sponsor

Region Skane

1. Study Identification

Unique Protocol Identification Number

NCT03017898

Brief Title

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

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Suspended

Why Stopped

Study halted due to lower success rates than expected, under evaluation, will potentially resume at a later date.

Study Start Date

March 3, 2017 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Region Skane

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fistula-In-Ano, Anal Fistula

Keywords

FiLaC, Fistula Laser Closure, Laser Coagulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Laser coagulation

Arm Type

Experimental

Arm Description

Treatment of anal fistulae meeting the inclusion criteria

Intervention Type

Procedure

Intervention Name(s)

Laser Coagulation

Other Intervention Name(s)

Fistula Laser Closure (FiLaC)

Intervention Description

Laser coagulation of anal fistula

Primary Outcome Measure Information:

Title

Healing

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Infection

Description

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

Title

Incontinence

Description

Presence of fecal incontinence as described by the patient

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Skåne University Hospital

City

Malmo

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21845480

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.

Results Reference

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PubMed Identifier

25724967

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.

Results Reference

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PubMed Identifier

24119103

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.

Results Reference

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PubMed Identifier

24509460

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.

Results Reference

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Treatment of Anal Fistula With Lasercoagulation

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