Intrauterine Adhesion Rate After Hysteroscopic Myomectomy and Application of HYALOBARRIER Gel
HYGEM
Prevention of Postsurgical Uterine Synechia With HyalobarrierR Gel Endo in Hysteroscopic Myomectomy : a Prospective Multicenter Study
1 other identifier
interventional
189
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedFirst Posted
Study publicly available on registry
August 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 28, 2017
March 1, 2017
5.3 years
May 16, 2011
March 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The formation of postsurgical uterine synechiae rate with HyalobarrierR Gel Endo in hysteroscopic myomectomy
between 4 and 8 weeks after initial hysteroscopic myomectomy
Secondary Outcomes (2)
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
Study Arms (1)
1
EXPERIMENTALFor each patient, the HYALOBARRIER Gel was introduced into the uterine cavity with the canula after hysteroscopic myomectomy procedure
Interventions
For each patient, the HYALOBARRIER Gel was introduced into the uterine cavity with the canula after hysteroscopic myomectomy procedure
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de Gynecologie-Obstetrique, Hopital Lariboisière
Paris, 75010, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Louis Benifla, MD, PhD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2011
First Posted
August 9, 2011
Study Start
August 1, 2011
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
March 28, 2017
Record last verified: 2017-03