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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01412489
First received: May 16, 2011
Last updated: March 4, 2014
Last verified: February 2014
  Purpose

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 Intervention
Myoma
Device: HYALOBARRIER Gel

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Postsurgical Uterine Synechia With HyalobarrierR Gel Endo in Hysteroscopic Myomectomy : a Prospective Multicenter Study

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • The formation of postsurgical uterine synechiae rate with HyalobarrierR Gel Endo in hysteroscopic myomectomy [ Time Frame: between 4 and 8 weeks after initial hysteroscopic myomectomy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the number of participants with adverse events as a measure of safety and tolerability during the time of the study [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Postsurgical fertility with evaluation of number of participants who became pregnant after surgery, spontaneously and/or after assisted reproductive technologies [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: August 2011
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: HYALOBARRIER Gel

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412489

Contacts
Contact: Jean-Louis Benifla, MD, PhD + 33 (0)1 44 73 51 18 jl.benifla@trs.aphp.fr

Locations
France
Service de Gynecologie-Obstetrique, Hopital Armand Trousseau Recruiting
Paris, France, 75012
Contact: Jean-Louis Benifla, MD, PhD    + 33 (0)1 44 73 51 18    jl.benifla@trs.aphp.fr   
Principal Investigator: Jean-Louis Benifla, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jean-Louis Benifla, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01412489     History of Changes
Other Study ID Numbers: K 100801
Study First Received: May 16, 2011
Last Updated: March 4, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Uterine synechiae
HyalobarrierR Gel Endo
Operative hysteroscopy
submucous myoma

Additional relevant MeSH terms:
Myoma
Gynatresia
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 24, 2014