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Prevention of Postsurgical Uterine Synechia With HyalobarrierR Gel Endo in Hysteroscopic Myomectomy : a Prospective Multicenter Study

18 Years
45 Years
Open (Enrolling)

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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:


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:


Principal Investigator

Jean-Louis Benifla, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

K 100801



Start Date:

August 2011

Completion Date:

December 2014

Related Keywords:

  • Myoma
  • Uterine synechiae
  • HyalobarrierR Gel Endo
  • Operative hysteroscopy
  • submucous myoma
  • Myoma
  • Gynatresia