Intrauterine Adhesion Rate After Hysteroscopic Myomectomy and Application of HYALOBARRIER Gel

Not Applicable

Completed

• Conditions: Myoma
• Interventions: Device: HYALOBARRIER Gel

• Registration Number: NCT01412489
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2011-05-16
• Study Start: 2011-08
• Study First Submitted QC: 2011-08-08
• Study First Posted: 2011-08-09
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 189

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The formation of postsurgical uterine synechiae rate with HyalobarrierR Gel Endo in hysteroscopic myomectomy	between 4 and 8 weeks after initial hysteroscopic myomectomy

Secondary Outcome Measures

Name	Time	Method
the number of participants with adverse events as a measure of safety and tolerability during the time of the study	2 years
Postsurgical fertility with evaluation of number of participants who became pregnant after surgery, spontaneously and/or after assisted reproductive technologies	2 years

Trial Locations

Locations (1)

Service de Gynecologie-Obstetrique, Hopital Lariboisière; 🇫🇷 Paris, France