Complex Anal FistulaNCT05201209
LASER FiLaC™ (FISTULA LASER CLOSURE) : First-line Treatment of Complex Anal Fistulas
An observational study of Complex Anal Fistula, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Complex anal fistula is a fistula whose treatment with fistulotomy would expose the patient to an excessive risk of post-operative continence disorders. It is a challenge in proctological surgery because of the complexity of its therapeutic management in relation to the recurrences' frequency and the need to preserve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Anal Fistula
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2019to 2 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with complex anal fistula treated by the FiLaC™ between 05/01/17 and 05/01/18
Who may be able to join
- Patient with complex anal fistula treated by the FiLaC™ between 05/01/17 and 05/01/18
Who cannot join
- Patient scheduled for treatment by FiLaC™ and collected as such but finally treated by fistulotomy given a fistula pathway considered intraoperatively less complex than expected
- Patient with recto vaginal or vaginal skin fistula
- Patient under guardianship or curators
- Patient deprived of liberty
- Patient objecting to the use of their data for this research
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Complex anal fistula is a fistula whose treatment with fistulotomy would expose the patient to an excessive risk of post-operative continence disorders. It is a challenge in proctological surgery because of the complexity of its therapeutic management in relation to the recurrences' frequency and the need to preserve sphincter function. Indeed, management is mainly based on fistulotomy techniques, but the latter expose patients to a significant alteration of their continence (less than 10% incontinence for simple fistulas but 30-50% for complex fistulas). In addition, these fistulas' management is constraining for patients due to the need for multiple interventions, long-term post-operative care and repeated discontinuation of activity.
Sphincteral saving techniques have therefore developed over the last three decades and have enriched the therapeutic panel of complex fistulas. They aim to block fistula pathways without risking altering sphincter function. In addition, their surgical consequences are often simple. However, they are associated with a greater risk of failure than after fistulotomy and sometimes disappointing to the point that some of these techniques have been gradually abandoned (biological glue and plug for example).
Read more
Among these sphincteral saving techniques, the investigators know the advancement flap, the injection of biological glue, plug's installation, the LIFT (Ligation of Inter sphincteric Fistula Tract), the clip's use but also, more recently a laser treatment, FiLaC™ (for Fistula Laser Closure), knowing that the idea was not new since the ND-YAG3 and CO24.5 lasers were already used in the treatment of anal fistulas, about twenty years ago, in experimental studies.
This technique consists of radiating 360° laser energy radially into the fistula path to "burn" it and causing thermal destruction by coagulation of the fistula wall ans granulation tissue2. It can bo offered to any type of fistula at risk on continence, including horseshoe extensions that can be treated at the same time. It is well suited for outpatient management because the postoperative period is simple and painless.
The literature is still poor on the subject with some studies published openly but the preliminary results are encouraging with a success rate of about 70%. No continence disorders reported.
Read the detailed description
A first retrospective study was conducted in the medical and surgical proctology department of the Hospital Group Paris Saint-Joseph on a cohort on 69 consecutive patients seen between May 2016 ans April 2017 and treated by FiLaC™ for a complex anal fistula. This technique has thus cured 60% of patients with superior trans-sphincter fistula. No incontinence-type complications were observed. These results, all the interesting as it was a learning phase, led the investigators to continue to use FiLaC™, which is currently practiced by all the team's practitioners as a first-line sphincter savings technique. The idea of this new work is to conduct an evaluation on a larger cohort of patients now that the investigators have more experience and it is being used routinely in the department at Groupe Hospitalier Paris Saint-Joseph.
- Conditions
- Complex Anal Fistula
- Keywords
- Fistula, Laser, Sphincter
- Medical subject headings
- Fistula
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess on a larger scale the cure rate of patients treated by the proctology department between May 2017 and May 2018 for complex anal fistula.
Clinical cure rate (in percentage) of complex anal fistula treated with FiLaC at the last medical contact in Groupe Hospitalier Paris Saint-Joseph.
Measured: 6 months
Secondary outcomes (3)
Identify predictive factors for clinical fistula healing to determine the best indications.
This outcome corresponds to evaluate the correlations between patients' clinical characteristics and cure rates.
Measured: 6 months
Confirm on a larger scale the absence of anal incontinence after treatment with FiLaC™ .
Comparison of Wexner's scores before and after the intervention. This score evaluates the importance of anal incontinence, it varies from 0 to 20, 20 corresponding to total incontinence.
It is criticized for varying too much according to the transit.
Measured: 1 year
Description of possible complications
This outcome corresponds to the number of events per person of other complications after surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start7 Feb 2019
- Primary completion2 Jun 2019
- Study completion2 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Complex Anal FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent De PARADES, M.D, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201209
- Sponsor's protocol ID
- LASER FILAC 2
- Status last verified
- Aug 2019
- First submitted
- 1 Aug 2019
- Last updated
- 21 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Limura E, Giordano P. Modern management of anal fistula. World J Gastroenterol. 2015 Jan 7;21(1):12-20. doi: 10.3748/wjg.v21.i1.12.
PubMed 25574077Wilhelm 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.
PubMed 21845480Ellison GW, Bellah JR, Stubbs WP, Van Gilder J. Treatment of perianal fistulas with ND:YAG laser--results in twenty cases. Vet Surg. 1995 Mar-Apr;24(2):140-7. doi: 10.1111/j.1532-950x.1995.tb01308.x.
PubMed 7778253Bodzin JH. Laser ablation of complex perianal fistulas preserves continence and is a rectum-sparing alternative in Crohn's disease patients. Am Surg. 1998 Jul;64(7):627-31; discussion 632.
PubMed 9655272Slutzki S, Abramsohn R, Bogokowsky H. Carbon dioxide laser in the treatment of high anal fistula. Am J Surg. 1981 Mar;141(3):395-6. doi: 10.1016/0002-9610(81)90207-5.
PubMed 6782904Giamundo 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.
PubMed 24119103Dudukgian H, Abcarian H. Why do we have so much trouble treating anal fistula? World J Gastroenterol. 2011 Jul 28;17(28):3292-6. doi: 10.3748/wjg.v17.i28.3292.
PubMed 21876616Soltani A, Kaiser AM. Endorectal advancement flap for cryptoglandular or Crohn's fistula-in-ano. Dis Colon Rectum. 2010 Apr;53(4):486-95. doi: 10.1007/DCR.0b013e3181ce8b01.
PubMed 20305451Lindsey I, Smilgin-Humphreys MM, Cunningham C, Mortensen NJ, George BD. A randomized, controlled trial of fibrin glue vs. conventional treatment for anal fistula. Dis Colon Rectum. 2002 Dec;45(12):1608-15. doi: 10.1007/s10350-004-7247-0.
PubMed 12473883Swinscoe MT, Ventakasubramaniam AK, Jayne DG. Fibrin glue for fistula-in-ano: the evidence reviewed. Tech Coloproctol. 2005 Jul;9(2):89-94. doi: 10.1007/s10151-005-0204-7. Epub 2005 Jul 8.
PubMed 16007368Johnson EK, Gaw JU, Armstrong DN. Efficacy of anal fistula plug vs. fibrin glue in closure of anorectal fistulas. Dis Colon Rectum. 2006 Mar;49(3):371-6. doi: 10.1007/s10350-005-0288-1.
PubMed 16421664Ortiz H, Marzo J, Ciga MA, Oteiza F, Armendariz P, de Miguel M. Randomized clinical trial of anal fistula plug versus endorectal advancement flap for the treatment of high cryptoglandular fistula in ano. Br J Surg. 2009 Jun;96(6):608-12. doi: 10.1002/bjs.6613.
PubMed 19402190Ozturk 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.
PubMed 24509460Rojanasakul A, Pattanaarun J, Sahakitrungruang C, Tantiphlachiva K. Total anal sphincter saving technique for fistula-in-ano; the ligation of intersphincteric fistula tract. J Med Assoc Thai. 2007 Mar;90(3):581-6.
PubMed 17427539Liu WY, Aboulian A, Kaji AH, Kumar RR. Long-term results of ligation of intersphincteric fistula tract (LIFT) for fistula-in-ano. Dis Colon Rectum. 2013 Mar;56(3):343-7. doi: 10.1097/DCR.0b013e318278164c.
PubMed 23392149
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LASER FiLaC™ (FISTULA LASER CLOSURE) : First-line Treatment of Complex Anal Fistulas
- ClinicalTrials.gov ID
- NCT05201209
- Acronym / sponsor ID
- LASER FILAC 2
- Conditions
- Complex Anal Fistula
- Keywords
- Fistula, Laser, Sphincter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 2 Jun 2019 (actual)
- Study completion
- 2 Jun 2019 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Complex anal fistula is a fistula whose treatment with fistulotomy would expose the patient to an excessive risk of post-operative continence disorders. It is a challenge in proctological surgery because of the complexity of its therapeutic management in relation to the recurrences' frequency and the need to preserve sphincter function. Indeed, management is mainly based on fistulotomy techniques, but the latter expose patients to a significant alteration of their continence (less than 10% incontinence for simple fistulas but 30-50% for complex fistulas). In addition, these fistulas' management is constraining for patients due to the need for multiple interventions, long-term post-operative care and repeated discontinuation of activity.
Sphincteral saving techniques have therefore developed over the last three decades and have enriched the therapeutic panel of complex fistulas. They aim to block fistula pathways without risking altering sphincter function. In addition, their surgical consequences are often simple. However, they are associated with a greater risk of failure than after fistulotomy and sometimes disappointing to the point that some of these techniques have been gradually abandoned (biological glue and plug for example).
Among these sphincteral saving techniques, the investigators know the advancement flap, the injection of biological glue, plug's installation, the LIFT (Ligation of Inter sphincteric Fistula Tract), the clip's use but also, more recently a laser treatment, FiLaC™ (for Fistula Laser Closure), knowing that the idea was not new since the ND-YAG3 and CO24.5 lasers were already used in the treatment of anal fistulas, about twenty years ago, in experimental studies.
This technique consists of radiating 360° laser energy radially into the fistula path to "burn" it and causing thermal destruction by coagulation of the fistula wall ans granulation tissue2. It can bo offered to any type of fistula at risk on continence, including horseshoe extensions that can be treated at the same time. It is well suited for outpatient management because the postoperative period is simple and painless.
The literature is still poor on the subject with some studies published openly but the preliminary results are encouraging with a success rate of about 70%. No continence disorders reported.
Detailed description
A first retrospective study was conducted in the medical and surgical proctology department of the Hospital Group Paris Saint-Joseph on a cohort on 69 consecutive patients seen between May 2016 ans April 2017 and treated by FiLaC™ for a complex anal fistula. This technique has thus cured 60% of patients with superior trans-sphincter fistula. No incontinence-type complications were observed. These results, all the interesting as it was a learning phase, led the investigators to continue to use FiLaC™, which is currently practiced by all the team's practitioners as a first-line sphincter savings technique. The idea of this new work is to conduct an evaluation on a larger cohort of patients now that the investigators have more experience and it is being used routinely in the department at Groupe Hospitalier Paris Saint-Joseph.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with complex anal fistula treated by the FiLaC™ between 05/01/17 and 05/01/18
Key inclusion criteria (1 listed)
- Patient with complex anal fistula treated by the FiLaC™ between 05/01/17 and 05/01/18
Key exclusion criteria (5 listed)
- Patient scheduled for treatment by FiLaC™ and collected as such but finally treated by fistulotomy given a fistula pathway considered intraoperatively less complex than expected
- Patient with recto vaginal or vaginal skin fistula
- Patient under guardianship or curators
- Patient deprived of liberty
- Patient objecting to the use of their data for this research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess on a larger scale the cure rate of patients treated by the proctology department between May 2017 and May 2018 for complex anal fistula.
Time frame: 6 months
Clinical cure rate (in percentage) of complex anal fistula treated with FiLaC at the last medical contact in Groupe Hospitalier Paris Saint-Joseph.
3 secondary outcomes
Identify predictive factors for clinical fistula healing to determine the best indications.
Time frame: 6 months
Confirm on a larger scale the absence of anal incontinence after treatment with FiLaC™ .
Time frame: 1 year
Description of possible complications
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Background: PubMed 25574077Limura E, Giordano P. Modern management of anal fistula. World J Gastroenterol. 2015 Jan 7;21(1):12-20. doi: 10.3748/wjg.v21.i1.12.
- Background: PubMed 21845480Wilhelm 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.
- Background: PubMed 7778253Ellison GW, Bellah JR, Stubbs WP, Van Gilder J. Treatment of perianal fistulas with ND:YAG laser--results in twenty cases. Vet Surg. 1995 Mar-Apr;24(2):140-7. doi: 10.1111/j.1532-950x.1995.tb01308.x.
- Background: PubMed 9655272Bodzin JH. Laser ablation of complex perianal fistulas preserves continence and is a rectum-sparing alternative in Crohn's disease patients. Am Surg. 1998 Jul;64(7):627-31; discussion 632.
- Background: PubMed 6782904Slutzki S, Abramsohn R, Bogokowsky H. Carbon dioxide laser in the treatment of high anal fistula. Am J Surg. 1981 Mar;141(3):395-6. doi: 10.1016/0002-9610(81)90207-5.
- Background: PubMed 24119103Giamundo 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.
- Background: PubMed 21876616Dudukgian H, Abcarian H. Why do we have so much trouble treating anal fistula? World J Gastroenterol. 2011 Jul 28;17(28):3292-6. doi: 10.3748/wjg.v17.i28.3292.
- Background: PubMed 20305451Soltani A, Kaiser AM. Endorectal advancement flap for cryptoglandular or Crohn's fistula-in-ano. Dis Colon Rectum. 2010 Apr;53(4):486-95. doi: 10.1007/DCR.0b013e3181ce8b01.
- Background: PubMed 12473883Lindsey I, Smilgin-Humphreys MM, Cunningham C, Mortensen NJ, George BD. A randomized, controlled trial of fibrin glue vs. conventional treatment for anal fistula. Dis Colon Rectum. 2002 Dec;45(12):1608-15. doi: 10.1007/s10350-004-7247-0.
- Background: PubMed 16007368Swinscoe MT, Ventakasubramaniam AK, Jayne DG. Fibrin glue for fistula-in-ano: the evidence reviewed. Tech Coloproctol. 2005 Jul;9(2):89-94. doi: 10.1007/s10151-005-0204-7. Epub 2005 Jul 8.
- Background: PubMed 16421664Johnson EK, Gaw JU, Armstrong DN. Efficacy of anal fistula plug vs. fibrin glue in closure of anorectal fistulas. Dis Colon Rectum. 2006 Mar;49(3):371-6. doi: 10.1007/s10350-005-0288-1.
- Background: PubMed 19402190Ortiz H, Marzo J, Ciga MA, Oteiza F, Armendariz P, de Miguel M. Randomized clinical trial of anal fistula plug versus endorectal advancement flap for the treatment of high cryptoglandular fistula in ano. Br J Surg. 2009 Jun;96(6):608-12. doi: 10.1002/bjs.6613.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent De PARADES, M.D principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Anal Fistula, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess on a larger scale the cure rate of patients treated by the proctology department between May 2017 and May 2018 for complex anal fistula. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05201209, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.