Status:
COMPLETED
Intrauterine Adhesion Rate After Hysteroscopic Myomectomy and Application of HYALOBARRIER Gel
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Myoma
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the intrauterine adhesion rate after the application of HYALOBARRIER Gel at the end of hysteroscopic myomectomy. Secondary endpoints were tolerance and side ef...
Detailed Description
Hysteroscopic myomectomy is the referent surgical treatment for submucous myoma. But intrauterine adhesion rate was evaluated about 7 to 15% after this procedure. The investigators hypothetically beli...
Eligibility Criteria
Inclusion
- 18 to 45 aged-patients
- hysteroscopic diagnosis of one submucous myoma with less than 3cm diameter requiring operative hysteroscopy with saline type 0, 1 or 2
- negative plasmatic βHCG test
- non opposition
- patients with social security
Exclusion
- multiple submucous myomas type 0, 1 or 2
- presurgical embolization
- presurgical impregnation with GnRH agonist
- coagulative disorders
- malignancies
- uncontrolled diabetes
- operative hysteroscopy with glycine
- known hypersensitivity to HyalobarrierR Gel Endo
- infection of the surgical area concerned
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT01412489
Start Date
August 1 2011
End Date
December 1 2016
Last Update
March 28 2017
Active Locations (1)
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1
Service de Gynecologie-Obstetrique, Hopital Lariboisière
Paris, France, 75010