WithdrawnNot Applicable

Comparing Intra Uterine Synechiae Occurence Using Bipolar Energy Compared With Monopolar Energy in Myoma Resection on Women Having Menorraghia and/or Infertility

Stopped: Principal investigator departure

Belgium, France0Started 2017-03-14

Plain-language summary

Since the development in the last few years of the bipolar energy in the surgery by hysteroscopy, the hysteroscopic treatment of the submucosal uterine myoma can be performed by use of either monopolar or bipolar current. It seems that the use of the bipolar energy decreases the rate of adhesions but prospective data on the adhesion rate and fertility after the use of bipolar energy during the surgery are poor, and there is currently no recommendation as to the choice of technique to use. The main purpose of this study is to compare the rate of uterine adhesions six weeks after the surgical hysteroscopic treatment of uterine submucosal myoma, by using monopolar or bipolar energy. The pregnancy and spontaneous miscarriage rate will also be evaluated.

Who can participate

Age range18 Years – 42 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: * Symptomatic (menorrhagia or primary/secondary infertility) with pregnancy wishes * One submucosal myoma, type 0 to Type II, accessible to a hysteroscopic surgery Exclusion Criteria: * Several submucosal myomas * Pregnant woman * Patient under anticoagulating treatment (anti-vitamin K-type) * Patient with a malignant endometrial pathology * Patient having one or more endo-uterine synechiae * Myoma larger than 5 cm * Uterine malformation * Active infection, not healed * Refusal to participate in the Protocol

What they're measuring

uterine adhesions rate

Timeframe: 6 weeks after surgery

Trial details

NCT IDNCT02661087

SponsorBrugmann University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-03