Intrauterine Adhesion Rate After Hysteroscopic Myomectomy and Application of HYALOBARRIER Gel

Myoma Clinical Trial

— HYGEM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412489
• Other study ID #: K 100801
• Status: Completed
• Phase: N/A
• First received: May 16, 2011
• Last updated: March 24, 2017
• Start date: August 2011
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 ßHCG 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

Related Conditions & MeSH terms

• Myoma

Intervention

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

Locations

Country	Name	City	State
France	Service de Gynecologie-Obstetrique, Hopital Lariboisière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The formation of postsurgical uterine synechiae rate with HyalobarrierR Gel Endo in hysteroscopic myomectomy		between 4 and 8 weeks after initial hysteroscopic myomectomy
Secondary	the number of participants with adverse events as a measure of safety and tolerability during the time of the study		2 years
Secondary	Postsurgical fertility with evaluation of number of participants who became pregnant after surgery, spontaneously and/or after assisted reproductive technologies		2 years