Prevention of Postsurgical Uterine Synechia With HyalobarrierR Gel Endo in Hysteroscopic Myomectomy : a Prospective Multicenter Study
18 Years
45 Years
Female
Myoma
Trial Information
Prevention of Postsurgical Uterine Synechia With HyalobarrierR Gel Endo in Hysteroscopic Myomectomy : a Prospective Multicenter Study
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 believe that application of HYALOBARRIER Gel at the end of the
procedure, could be reduce the mean intrauterine rate to 50%. Thus, the investigators
performed a multicenter (n = 20) prospective study non randomized in 220 patients with
submucous myoma < 3 cm of diameter, evaluated by preoperative ultrasound. The investigators
prefer this study design, because the principal reason is the number of enrolled patient
were more 200 patients in each group with a double blind randomized study. Now, in all
patients, after hysteroscopic myomectomy which performed with a same technique in each
center (bipolar coagulation and physiologic serum), a diagnostic hysteroscopy was performed
at 2 month to determinate the existence of intrauterine adhesion. Secondary end points were
in this study the tolerance and side effects of HYALOBARRIER Gel and the subsequent
fertility at 2 years.
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
The formation of postsurgical uterine synechiae rate with HyalobarrierR Gel Endo in hysteroscopic myomectomy
Outcome Time Frame:
between 4 and 8 weeks after initial hysteroscopic myomectomy
Safety Issue:
No
Principal Investigator
Jean-Louis Benifla, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Assistance Publique - Hôpitaux de Paris
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
K 100801
NCT ID:
NCT01412489
Start Date:
August 2011
Completion Date:
December 2014
Related Keywords:
- Myoma
- Uterine synechiae
- HyalobarrierR Gel Endo
- Operative hysteroscopy
- submucous myoma
- Myoma
- Gynatresia
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