Complex Anal Fistula Clinical Trial
— FISCLOSEOfficial title:
Therapeutic Management of Complex Anal Fistulas by Installing a Closure Clip: Multicentre Randomized Controlled Trial
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.
| Status | Recruiting |
| Enrollment | 92 |
| Est. completion date | February 2017 |
| Est. primary completion date | January 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de Clermont-Ferrand | Clermont-Ferrand |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Anal fistula healing | at 6 months and 1 year | No | |
| Secondary | VAS proctologic pain | days 0, 1, 2, 3, 15, 30, 60, 90, 180 and 365 | No | |
| Secondary | Anal incontinence score (questionnaire Jorge and Wexner) | days 0, 15, 30, 60, 90, 180 and 365 | No | |
| Secondary | Digestive disorders and quality of life (GIQLI questionnaire) | days 0, 15, 30, 60, 90, 180 and 365 | No | |
| Secondary | Quality of life (EQ5D Questionnaire) | days 0, 30, 90, 365 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01612195 -
Success Rate, Continence, and Quality of Life With a Bioprosthetic Plug for Treating Complex Anal Fistula
|
Phase 2 | |
| Completed |
NCT05201209 -
LASER FiLaC™ (FISTULA LASER CLOSURE) : First-line Treatment of Complex Anal Fistulas
|