Patients with anal fistula
Conditions
Interventions
Product Name: PLATELET RICH FACTORS
Product Code: other plasma protein fractions
Pharmaceutical Form: Injection
INN or Proposed INN: PRGF
Other descriptive name: PLATELETS
Concentration unit: % percen
Sponsors
FISEVI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signature of consent, age greater than 18 years and complex fistulas of cryptoglandular origin with a single path, and equal number of internal and external holes. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Non-resolved interposed or coexisting collections, non-localization of the internal orifice, simple fistula (submucosal / subcutaneous / low-interphosphorylated), pregnant, active or past cancer in less than 5 years, HIH, anal stricture to prevent anal fistula exploration, allergy To the sealing product used, rectovaginal fistulas, active or non-rectal inflammatory disease, inability to follow up, platelet antiplatelet therapy that can not be discontinued at least one week before surgery and one week later patients receiving Currently any investigational drug, or have received it within 3 months prior to enrollment in this clinical trial.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The safety assessment will be part of the secondary endpoints and include possible adverse events PRGF measured by recording adverse events reported during the study and clinical findings of the physical examination. The evaluation will also consider the evaluation of fecal incontinence.;Timepoint(s) of evaluation of this end point: At three, six, and twelve months after treatment | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study was to evaluate the efficacy and safety of plasma rich in growth factors as adjuvant to curettage and simple closure of the internal orifice compared to a control group (serum) in patients with complex cryptoglandular anal fistulas. Efficacy and safety will be monitored for a total of 12 months after completion of treatment. Primary objective To assess efficacy by the proportion of responders after 12 months of treatment, compared with responders to placebo.;Secondary Objective: Secondary Objectives The secondary efficacy endpoints (comparing both groups) are as follows: - Evaluate the clinical response - total or partial - at each visit and at the end of the trial, with respect to the baseline data. - Evaluate the time to clinical remission - total or partial - defined at each visit and at the end of the trial, compared to the baseline data. - Evaluate the response by endoanal ultrasound / MRI at the end of the trial with respect to baseline ultrasound data. - Evaluate the variations in the quality of life assessed by the Quality of Life Questionnaire SF36 at each visit and at the end of the trial, compared to the baseline data. The safety assessment will be part of the secondary endpoints and will include potential PRFG adverse events measured by recording adverse events reported during the study and the clinical findings of physical examination. The evaluation will also consider the assessment of fecal incontinence.;Primary end point(s): The fistula is considered cured when the external fistula orifice, are closed and / or does not drain after compression finger. Persistence of symptoms after three months of surgery: recurrence and / or failure of treatment is considered.;Timepoint(s) of evaluation of this end point: At three, six, and twelve months after treatment | — |
Countries
Spain
Contacts
Public ContactFISEVI
FISEVI
Outcome results
None listed