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Efficacy of In-bag Morcellation

NCT03281460 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-09-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Gautier CHENE, MD · Gynaecology Department, Hôpital Femme Mère Enfant, HCL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-25
Primary Completion
2019-01-21
Completion
2019-01-21

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03281460 on ClinicalTrials.gov