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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
SygeLIX-F (plug) is inserted through the internal orifice while cryptoglandular space is filled by SygeLIX-G (gel).
Clinique Blomet
Paris, France
Maison de Santé Protestante de Bordeaux-Bagatelle
Talence, France
Evaluation of intensity of perineal inflammation following treatment
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).
Time frame: Through study completion (45 days)
Rate of plug expulsion and surgical revision due to complications
Time frame: Through study completion (45 days)
Type and incidence of adverse events (AE) and serious adverse events (SAE)
Time frame: Through study completion (45 days)
Evaluation of surgical technique
Questionnaire on surgical technique including ease of plug suture to the mucosa and of gel use.
Time frame: Time of investigational products surgical implantation (Day 0)
Plug integration
Assessment of anal continence by the Vaizey score (0 = perfect continence, 24 = totally incontinent).
Time frame: 30 days, 45 days
Cessation of fistula flow
Healing of the fistula orifices assessed by palpation and pinching.
Time frame: 45 days
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