NCT02336867

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

2 years

First QC Date

January 8, 2015

Last Update Submit

September 18, 2015

Conditions

Complex Anal Fistula

Keywords

Complex anal fistula, clip,

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with healed anal fistula

    The diagnosis will be made by the lack of leakage alleged by the patient for at least one month and found on clinical examination

    at 3 months after surgery

Secondary Outcomes (5)

  • Anal fistula healing

    at 6 months and 1 year

  • VAS proctologic pain

    days 0, 1, 2, 3, 15, 30, 60, 90, 180 and 365

  • Anal incontinence score (questionnaire Jorge and Wexner)

    days 0, 15, 30, 60, 90, 180 and 365

  • Digestive disorders and quality of life (GIQLI questionnaire)

    days 0, 15, 30, 60, 90, 180 and 365

  • Quality of life (EQ5D Questionnaire)

    days 0, 30, 90, 365

Study Arms (2)

Experimental group

EXPERIMENTAL

closure clip (OTSC® Proctology Laboratory: OVESCO and French Distributor: Life Partners)

Device: Closure clip (OTSC® Proctology)

Control group

OTHER

advancement flap technique

Device: Closure clip (OTSC® Proctology)

Interventions

Closure clip (OTSC® Proctology)DEVICE
Control groupExperimental group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (1)

  • Dubois A, Carrier G, Pereira B, Gillet B, Faucheron JL, Pezet D, Balayssac D. Therapeutic management of complex anal fistulas by installing a nitinol closure clip: study protocol of a multicentric randomised controlled trial--FISCLOSE. BMJ Open. 2015 Dec 16;5(12):e009884. doi: 10.1136/bmjopen-2015-009884.

    PMID: 26674505DERIVED

Study Officials

  • Anne DUBOIS

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2015

First Posted

January 13, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

September 22, 2015

Record last verified: 2015-09

Locations

FR(1)