Clinical trial NCT01412489: Intrauterine Adhesion Rate After Hysteroscopic Myomectomy and Application of HYALOBARRIER Gel
Official title: Prevention of Postsurgical Uterine Synechia With HyalobarrierR Gel Endo in Hysteroscopic Myomectomy : a Prospective Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myoma
Keywords: Uterine synechiae
HyalobarrierR Gel Endo
Operative hysteroscopy
submucous myoma
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2011-08-09
Enrollment: 189
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 effect and subsequent fertility.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: The formation of postsurgical uterine synechiae rate with HyalobarrierR Gel Endo in hysteroscopic myomectomy
timeFrame: between 4 and 8 weeks after initial hysteroscopic myomectomy
Secondary outcomes:
measure: the number of participants with adverse events as a measure of safety and tolerability during the time of the study
timeFrame: 2 years
measure: Postsurgical fertility with evaluation of number of participants who became pregnant after surgery, spontaneously and/or after assisted reproductive technologies
timeFrame: 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Gynecologie-Obstetrique, Hopital Lariboisière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Louis Benifla, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: