Intrauterine Adhesion Rate After Hysteroscopic Myomectomy and Application of HYALOBARRIER Gel (HYGEM)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Myoma

Treatments: Device: HYALOBARRIER Gel

Study type: Interventional

Funder types: Other

Identifiers

NCT01412489

K 100801

Details and patient eligibility

About

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 effect and subsequent fertility.

Full 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 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.

Enrollment: 189 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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189 participants in 1 patient group

1

Experimental group

Description:

For each patient, the HYALOBARRIER Gel was introduced into the uterine cavity with the canula after hysteroscopic myomectomy procedure

Treatment:

Device: HYALOBARRIER Gel