NCT03017898

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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 3, 2017

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

8.3 years

First QC Date

January 9, 2017

Last Update Submit

February 29, 2024

Conditions

Fistula-In-AnoAnal Fistula

Keywords

FiLaCFistula Laser ClosureLaser Coagulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Infection

    12 months

  • Incontinence

    12 months

Study Arms (1)

Laser coagulation

EXPERIMENTAL

Treatment of anal fistulae meeting the inclusion criteria

Procedure: Laser Coagulation

Interventions

Laser CoagulationPROCEDURE

Laser coagulation of anal fistula

Also known as: Fistula Laser Closure (FiLaC)
Laser coagulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skåne University Hospital

Malmo, Sweden

Location

Related Publications (4)

  • 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.

    PMID: 21845480BACKGROUND

  • 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.

    PMID: 25724967BACKGROUND

  • 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.

    PMID: 24119103BACKGROUND

  • 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.

    PMID: 24509460BACKGROUND

MeSH Terms

Conditions

Rectal Fistula

Interventions

Laser Coagulation

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Light CoagulationHemostatic TechniquesTherapeuticsLaser TherapyAblation TechniquesSurgical Procedures, OperativeHemostasis, SurgicalOphthalmologic Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2017

First Posted

January 11, 2017

Study Start

March 3, 2017

Primary Completion

June 1, 2025

Study Completion

December 1, 2025

Last Updated

March 1, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)