Status:
UNKNOWN
Hyaluronic Acid for the Prevention of Endocavitary Synechiae After Myomectomy
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Patients With an Indication for Myomectomy or Polymyomectomy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
PREVENDO is a prospective, multicenter, pilot, and randomized study in 2 parallel arms and single blind, evaluating the proportion of endometrial synechiae 6 weeks after surgery in patients undergoing...
Detailed Description
Myomas are a common pathology affecting a large population of women of reproductive age. Depending on their location and the patient's symptoms, surgical removal of fibroids may be indicated. Interst...
Eligibility Criteria
Inclusion
- Age ≥ 18
- Of childbearing age
- Indication of myomectomy / polymyomectomy by laparotomy / laparoscopy / robot-assisted laparoscopy
- FIGO 2 to 6 classification myomas
Exclusion
- History of intra uterine synechia treatment
- Uterine malformation
- Patients under legal protection measure (guardianship or curatorship) or under security measure
- Pregnant or breastfeeding women
- Absence of health insurance; or patient with AME
- Absence of free, informed and written consent
- Endometrial synechia before operation (grade 1-3) (assessed by systematic diagnostic hysteroscopy)
- Patient with upper genital infection
- Hypersensibility to hyaluronic acid
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2022
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT04702399
Start Date
February 1 2021
End Date
May 1 2022
Last Update
January 8 2021
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