Hyaluronic Acid for the Prevention of Endocavitary Synechiae After Myomectomy
NCT ID: NCT04702399
Last Updated: 2021-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
76 participants
INTERVENTIONAL
2021-02-01
2022-05-01
Brief Summary
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Detailed Description
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Interstitial or subserous myomas are accessible through the abdominal route (laparotomy or minimally invasive surgery).
The impact of this surgery on the endometrial cavity and the risk of post-surgery synechiae is poorly understood, although it is essential, especially in a population of women wishing to preserve their fertility. In order to reduce and prevent endometrial synechia formation, we suggest PREVENDO study which consist in the systematic intracavitary placement of an anti-adhesion gel (HYALOBARRIER® GEL ENDO) immediately after surgery in patients undergoing abdominal myomectomy or polymyomectomy (laparotomy, laparoscopy, robot-assisted laparoscopy) and the evaluation of the proportion of endometrial synechiae 6 weeks after surgery in patients during diagnostic hysteroscopy performed 6 weeks after surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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GEL GROUP
Intracavitary application of an anti-adhesion hyaluronic acid gel (HYALOBARRIER® GEL ENDO)
GEL GROUP
Application of an anti-adhesion gel (HYALOBARRIER® GEL ENDO) in the uterine cavity
CONTROL GROUP
No Intervention
No interventions assigned to this group
Interventions
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GEL GROUP
Application of an anti-adhesion gel (HYALOBARRIER® GEL ENDO) in the uterine cavity
Eligibility Criteria
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Inclusion Criteria
2. Of childbearing age
3. Indication of myomectomy / polymyomectomy by laparotomy / laparoscopy / robot-assisted laparoscopy
4. FIGO 2 to 6 classification myomas
Exclusion Criteria
2. Uterine malformation
3. Patients under legal protection measure (guardianship or curatorship) or under security measure
4. Pregnant or breastfeeding women
5. Absence of health insurance; or patient with AME
6. Absence of free, informed and written consent
7. Endometrial synechia before operation (grade 1-3) (assessed by systematic diagnostic hysteroscopy)
8. Patient with upper genital infection
9. Hypersensibility to hyaluronic acid
18 Years
FEMALE
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Geoffroy Doctor CANLORBE
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Central Contacts
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Other Identifiers
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APHP200247
Identifier Type: -
Identifier Source: org_study_id
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