CompletedNot Applicable

Efficacy of In-bag Morcellation

France48 participantsStarted 2018-01-25

Plain-language summary

Laparoscopic mini-invasive surgery supplanted laparotomy for many years, including hysterectomy or myomectomy (less postoperative complications compared to laparotomy) However the US Federal Drug Administration (FDA) strongly warned against the use of power morcellation in 2014 because of the risk of iatrogenic spread of malignant cells. The hypothesis is that in-bag morcellation may prevent cells dissemination. The investigator compare in this prospective randomized study two groups of patients: group A (in bag-morcellation during laparoscopic myomectomy or hysterectomy) versus group B (morcellation without any bag during laparoscopic myomectomy or hysterectomy)

Who can participate

Age range18 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: * Women aged 18 years or more * Laparoscopic myomectomy or laparoscopic subtotal hysterectomy * Informed and signed consent Exclusion Criteria: * Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc. * Preoperative risk of leiomyosarcoma or pelvic carcinoma * Pregnancy or desire of pregnancy during the study period * Uterus or myomas weight above 1.000 g * Inability to understand information provided * Not covered by a national health insurance scheme, prisoner or under administrative supervision

What they're measuring

Smooth muscular cells in the peritoneal fluid after morcellation

Timeframe: Day 0 - just after surgery

Trial details

NCT IDNCT03281460

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-21

View on ClinicalTrials.gov More Uterine Myomatosis trials