Anal Fistula
Conditions
Brief summary
The purpose of this open, multicenter pilot trial is to evaluate the tolerance of the combination of a gel and a plug made of Wharton's jelly in the treatment of ano-perineal fistulas resistant to surgical treatment.
Interventions
BIOLOGICALSygeLIX-F + SygeLIX-G
SygeLIX-F (plug) is inserted through the internal orifice while cryptoglandular space is filled by SygeLIX-G (gel).
Sponsors
TBF Genie Tissulaire
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, aged 18 to 65 years. * Patient with a single anal fistula resistant after at least one surgical treatment. Fistula may be related to Crohn's disease. * Patient with an upper transsphincteric or lower transsphincteric fistula. * Patient presenting fistula with or without intersphincteric diverticula. * Fistula effectively drained with a seton. * Informed and consenting patient. * Patient who is a member or a beneficiary of a national health insurance plan.
Exclusion criteria
* Pregnant or breastfeeding woman or woman of childbearing age without effective contraception. * Patients who have had more than one failed obstruction technique. * Patient with more than one internal orifice. * Patient with an MRI proven abscess. * Patient with an uncontrolled infection. * Patient with a contraindication to anesthesia. * Person deprived of liberty by a judicial or administrative decision. * Adult subjected to a legal protection measure or unable to express his / her consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of intensity of perineal inflammation following treatment | Through study completion (45 days) | Scoring of pain (0 = no pain, 10 = worst pain possible), redness (0 = no redness, 4 = redness covering an area \> 5 cm), edema (0 = no edema, 4 = area completely swollen), ulceration (0 = no ulceration, 4 = ulcer larger than 1 cm). |
| Rate of plug expulsion and surgical revision due to complications | Through study completion (45 days) | — |
| Type and incidence of adverse events (AE) and serious adverse events (SAE) | Through study completion (45 days) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of surgical technique | Time of investigational products surgical implantation (Day 0) | Questionnaire on surgical technique including ease of plug suture to the mucosa and of gel use. |
| Plug integration | 30 days, 45 days | Assessment of anal continence by the Vaizey score (0 = perfect continence, 24 = totally incontinent). |
| Cessation of fistula flow | 45 days | Healing of the fistula orifices assessed by palpation and pinching. |
Countries
France
Outcome results
None listed