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Therapeutic Management of Complex Anal Fistulas by Installing a Closure Clip: Multicentre Randomized Controlled Trial (FISCLOSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02336867
Recruitment Status : Unknown
Verified September 2015 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : January 13, 2015
Last Update Posted : September 22, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

Anal fistulas are the main etiology of perianal abscesses and suppurations. They are common and generally associated with pain, anal incontinence, impaired quality of life and work incapacity. The therapeutic management of this disease has a double objective: heal the suppuration and preserve the sphincter function. Each year, anal fistulas affect 1 in 10 000 in the normal population, with a difference in prevalence between men and women (1.23 per 10 000 men and 0.56 per 10 000 women). The average age of the patients was 40 years (Simpson et al., 2012).

In about 80% of cases, anal fistulas are secondary to an infection of Hermann and Desfosses' anal glands (cryptogenic or cryptoglandular). Infection of the anal gland can result in an abscess between the internal and external sphincters, which in turn can spread to other parts of the perianal region. The infection can follow many directions from this point in the intersphincteric plan. When the pus reaches the skin, the fistula is formed. Anal fistula therefore has always an intraductal origin, cryptic, with a primary port at this level, and the disregard of which causes the recurrence of the fistula; and usually a secondary port in the skin.

Fistulas are usually divided into two groups. The first group contains fistulas called "simple", which are intersphincteric fistulas or trans-sphincteric involving only the lower third of the sphincter complex. Fistulas usually didn't affect any muscle. The second group contains fistulas called "complex". These are intersphincteric, trans-sphincteric, or even suprasphincteric, extrasphincteric fistulas.

For many years, the treatment of choice was to open the fistula (fistulotomy), but this procedure was associated with a risk of incontinence, the consequences could be potentially devastating. Other surgical treatments include setons, fibrin glue, collagen plugs and advancement flap technique to cover internal opening of the fistula. The success of these therapies remains variable.

The advancement flap technique remains a strategy of choice in the treatment of anal fistulas and particularly in the case of complex fistulas. The success rate of the advancement flap technique remains variable across studies but a recent meta-analysis finds a success rate of around 60%.

A new technique for closing anal fistula is currently in development with the use of a closure clip nitinol (OTSC® Proctology Laboratory: OVESCO and French Distributor: Life Partners). This new technique has been validated in a porcine model of anal fistula, ensuring the safety of the device. A first case was published in a patient with complex anal fistula (high trans-sphincteric). After erosion fistula tract with a special brush, a nitinol clip (OTSC® Proctology) was deposited on the internal opening of the fistula. Eight months after surgery, the fistula was healed and the clip was removed by cutting with special pliers. This technique is currently being broadcast and dozens of patients were treated with this clip without any further scientific validation of the process.

To date, this innovative technique of the closure clip has not yet been assessed in a randomized controlled trial. It is therefore essential to carry out a prospective evaluation in order to determine the effectiveness and safety of this new device in the case of complex anal fistulas.


Condition or disease Intervention/treatment Phase
Complex Anal Fistula Device: Closure clip (OTSC® Proctology) Phase 2 Phase 3

Detailed Description:

After validation of the inclusion and exclusion criteria, the patients included in this clinical trial will be randomized between the two arms of the study for the closure of the anal fistula:

  • Control group: advancement flap technique Experimental group: closure clip (OTSC® Proctology Laboratory: OVESCO and French Distributor: Life Partners)

Follow up of the patients will be performed until 1 year after the intervention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Therapeutic Management of Complex Anal Fistulas by Installing a Closure Clip: Multicentre Randomized Controlled Trial
Study Start Date : January 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: Experimental group
closure clip (OTSC® Proctology Laboratory: OVESCO and French Distributor: Life Partners)
Device: Closure clip (OTSC® Proctology)
Control group
advancement flap technique
Device: Closure clip (OTSC® Proctology)



Primary Outcome Measures :
  1. Proportion of patients with healed anal fistula [ Time Frame: at 3 months after surgery ]
    The diagnosis will be made by the lack of leakage alleged by the patient for at least one month and found on clinical examination


Secondary Outcome Measures :
  1. Anal fistula healing [ Time Frame: at 6 months and 1 year ]
  2. VAS proctologic pain [ Time Frame: days 0, 1, 2, 3, 15, 30, 60, 90, 180 and 365 ]
  3. Anal incontinence score (questionnaire Jorge and Wexner) [ Time Frame: days 0, 15, 30, 60, 90, 180 and 365 ]
  4. Digestive disorders and quality of life (GIQLI questionnaire) [ Time Frame: days 0, 15, 30, 60, 90, 180 and 365 ]
  5. Quality of life (EQ5D Questionnaire) [ Time Frame: days 0, 30, 90, 365 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Complex anal fistula (intersphincteric, trans-sphincteric, or even suprasphincteric, extrasphincteric) drained and requiring closing intervention of fistula.
  • Obtaining the patient's written consent
  • Naive patient to any surgical treatment for fistula closure
  • Patient receiving a social security scheme

Exclusion Criteria:

  • <18 years and> 80 years
  • BMI> 35 kg / m²
  • Rectovaginal or rectourethral fistulas
  • Infections : sepsis, tuberculosis or HIV
  • History of allergy to nickel
  • Cognitive disorders or major disability making it impossible to understand the study and signed an informed consent
  • Already included in another clinical trial patients
  • breastfeeding or pregnancy
  • Legal incapacity (person deprived of liberty or guardianship)
  • Patients not compliant with the criteria of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336867


Contacts
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Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
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France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Anne DUBOIS University Hospital, Clermont-Ferrand
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02336867    
Other Study ID Numbers: CHU-2018
2014-A00441-46 ( Registry Identifier: 2014-A00441-46 )
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: September 22, 2015
Last Verified: September 2015
Keywords provided by University Hospital, Clermont-Ferrand:
Complex anal fistula, clip,
Additional relevant MeSH terms:
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Rectal Fistula
Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases