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CompletedNCT03281460FIBROSACUpdated Sep 2, 2025

Efficacy of In-bag Morcellation

An interventional study of laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation and laparoscopic myomectomy or hysterectomy without any morcellation bag in Uterine Myomatosis, Laparoscopy and Hysterectomy, Vaginal, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-02.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

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)

02

Conditions studied

  • Uterine Myomatosis
  • Laparoscopy
  • Hysterectomy, Vaginal

Keywords

  • Hysterectomy, Vaginal
  • Uterine Myomatosis
  • Morcellation
  • Laparoscopy
  • in-bag morcellation
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Women aged 18 years or more
  • Laparoscopic myomectomy or laparoscopic subtotal hysterectomy
  • Informed and signed consent

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    with in-bag morcellation

    with More-cell-Safe AMI bag morcellation

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

  • Active comparator
    without any morcellation bag

    without any morcellation bag

    Procedure: laparoscopic myomectomy or hysterectomy without any morcellation bag

Interventions

  • Devicelaparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation

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

  • Procedurelaparoscopic myomectomy or hysterectomy without any morcellation bag

    laparoscopic myomectomy or hysterectomy without any morcellation bag

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. duration of surgery

    Time frame: Day 0

  2. morcellation time

    Time frame: Day 0 - during surgery

  3. peritoneal washing time

    Time frame: Day 0 - during surgery

  4. residual morcellated tissues weight

    Time frame: Day 0 - during surgery

  5. bag associated time

    Time frame: Day 0 - during surgery

  6. ease of use

    assessment by a visual analogical scale

    Time frame: Day 0 - during surgery

06

Study locations

1 site
  • Gynaecology Department, Hôpital Femme Mère Enfant
    Bron, 69500, France
07

References and documents

Publications

  • Bensouda-Miguet C, Nohuz E, Cerruto E, Buenerd A, Nadaud B, Moret S, Chene G. Inbag Morcellation Applied to the Laparoscopic Surgery of Leiomyoma: A Randomized Controlled Trial. Biomed Res Int. 2021 May 26;2021:6611448. doi: 10.1155/2021/6611448. eCollection 2021. PubMed 34136570 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03281460
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Sep 13, 2017
Start date
Jan 25, 2018
Primary completion
Jan 21, 2019
Completion
Jan 21, 2019
Last update
Sep 2, 2025

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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