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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT01412489

Collaborator

(none)

189

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myoma	Device: HYALOBARRIER Gel	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

189 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 For each patient, the HYALOBARRIER Gel was introduced into the uterine cavity with the canula after hysteroscopic myomectomy procedure	Device: HYALOBARRIER Gel For each patient, the HYALOBARRIER Gel was introduced into the uterine cavity with the canula after hysteroscopic myomectomy procedure

Arm

Intervention/Treatment

Experimental: 1

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

Device: HYALOBARRIER Gel

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service de Gynecologie-Obstetrique, Hopital Lariboisière	Paris		France	75010

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Jean-Louis Benifla, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT01412489

Other Study ID Numbers:

K 100801

First Posted:

Aug 9, 2011

Last Update Posted:

Mar 28, 2017

Last Verified:

Mar 1, 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris

Uterine synechiae

HyalobarrierR Gel Endo

Operative hysteroscopy

submucous myoma

Additional relevant MeSH terms:

Myoma

Study Results

No Results Posted as of Mar 28, 2017