CompletedNot Applicable

Intrauterine Adhesion Rate After Hysteroscopic Myomectomy and Application of HYALOBARRIER Gel

France189 participantsStarted 2011-08

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

The formation of postsurgical uterine synechiae rate with HyalobarrierR Gel Endo in hysteroscopic myomectomy

Timeframe: between 4 and 8 weeks after initial hysteroscopic myomectomy

Trial details

NCT IDNCT01412489

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12

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