Efficacy of In-bag Morcellation (FIBROSAC)

Civil Hospices of Lyon

Status

Completed

Conditions

Hysterectomy, Vaginal

Uterine Myomatosis

Laparoscopy

Treatments

Device: laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation

Procedure: laparoscopic myomectomy or hysterectomy without any morcellation bag

Study type

Interventional

Funder types

Other

Identifiers

NCT03281460

2017-A01773-50 (Other Identifier)

69HCL16_0714

Details and patient eligibility

About

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)

Enrollment

48 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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