NCT03281460

Efficacy of In-bag Morcellation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Uterine Myomatosis
• Laparoscopy
• Hysterectomy, Vaginal

Interventions

Type	Name	Description
DEVICE	laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation	laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation
PROCEDURE	laparoscopic myomectomy or hysterectomy without any morcellation bag	laparoscopic myomectomy or hysterectomy without any morcellation bag

Timeline

• Start date: 2018-01-25
• Primary completion: 2019-01-21
• Completion: 2019-01-21
• First posted: 2017-09-13
• Last updated: 2025-09-02

Locations

1 site across 1 country: France