Efficacy of In-bag Morcellation

Hospices Civils de Lyon48 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Uterine Myomatosis Laparoscopy Hysterectomy, Vaginal

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Smooth muscular cells in the peritoneal fluid after morcellation

After morcellation, there will be cytology and immunohistochemistry of peritoneal washing with 500cc of saline serum

Time frame: Day 0 - just after surgery