LASER FiLaC™ (FISTULA LASER CLOSURE) : First-line Treatment of Complex Anal Fistulas

Complex Anal Fistula Clinical Trial

Official title:

LASER FiLaC™ (FISTULA LASER CLOSURE) : First-line Treatment of Complex Anal Fistulas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05201209
• Other study ID #: LASER FILAC 2
• Status: Completed
• Start date: February 7, 2019
• Est. completion date: June 2, 2019

Study information

• Verified date: August 2019
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 2, 2019
• Est. primary completion date: June 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with complex anal fistula treated by the FiLaC™ between 05/01/17 and 05/01/18

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Complex Anal Fistula
• Fistula
• Rectal Fistula

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (17)

Bodzin 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. — View Citation

Dudukgian 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. — View Citation

Ellison 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. — View 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. — 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

Herreros MD, Garcia-Arranz M, Guadalajara H, De-La-Quintana P, Garcia-Olmo D; FATT Collaborative Group. Autologous expanded adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistulas: a phase III randomized clinical trial (FATT 1: fistula Advanced Therapy Trial 1) and long-term evaluation. Dis Colon Rectum. 2012 Jul;55(7):762-72. doi: 10.1097/DCR.0b013e318255364a. — View Citation

Johnson 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. — View Citation

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. Review. — View Citation

Lindsey 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. — View Citation

Liu 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. — View Citation

Ortiz H, Marzo J, Ciga MA, Oteiza F, Armendáriz 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. — View Citation

Oztürk E, Gülcü 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

Rojanasakul 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. — View Citation

Slutzki S, Abramsohn R, Bogokowsky H. Carbon dioxide laser in the treatment of high anal fistula. Am J Surg. 1981 Mar;141(3):395-6. — View Citation

Soltani 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. Review. — View Citation

Swinscoe MT, Ventakasubramaniam AK, Jayne DG. Fibrin glue for fistula-in-ano: the evidence reviewed. Tech Coloproctol. 2005 Jul;9(2):89-94. Epub 2005 Jul 8. Review. — 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

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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.	6 months
Secondary	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.	1 year
Secondary	Description of possible complications	This outcome corresponds to the number of events per person of other complications after surgery	1 year