Informations générales (source: ClinicalTrials.gov)
Therapeutic Management of Complex Anal Fistulas by Installing a Closure Clip: Multicentre Randomized Controlled Trial (FISCLOSE)
Interventional
Phase 2/Phase 3
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
janvier 2015
février 2017
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU de Clermont-Ferrand - 63003 - Clermont-Ferrand - France | Patrick LACARIN | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- <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