NCT03281460

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 25, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2019

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

12 months

First QC Date

September 11, 2017

Last Update Submit

August 28, 2025

Conditions

Uterine MyomatosisLaparoscopyHysterectomy, Vaginal

Keywords

Hysterectomy, VaginalUterine MyomatosisMorcellationLaparoscopyin-bag morcellation

Outcome Measures

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

    Day 0 - just after surgery

Secondary Outcomes (6)

  • duration of surgery

    Day 0

  • morcellation time

    Day 0 - during surgery

  • peritoneal washing time

    Day 0 - during surgery

  • residual morcellated tissues weight

    Day 0 - during surgery

  • bag associated time

    Day 0 - during surgery

  • +1 more secondary outcomes

Study Arms (2)

with in-bag morcellation

EXPERIMENTAL

with More-cell-Safe AMI bag morcellation

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

without any morcellation bag

ACTIVE COMPARATOR

without any morcellation bag

Procedure: laparoscopic myomectomy or hysterectomy without any morcellation bag

Interventions

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

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

with in-bag morcellation
laparoscopic myomectomy or hysterectomy without any morcellation bagPROCEDURE

laparoscopic myomectomy or hysterectomy without any morcellation bag

without any morcellation bag

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynaecology Department, Hôpital Femme Mère Enfant

Bron, 69500, France

Location

Related Publications (1)

  • 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.

    PMID: 34136570BACKGROUND

MeSH Terms

Interventions

Hysterectomy

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Gautier CHENE, MD

    Gynaecology Department, Hôpital Femme Mère Enfant, HCL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 13, 2017

Study Start

January 25, 2018

Primary Completion

January 21, 2019

Study Completion

January 21, 2019

Last Updated

September 2, 2025

Record last verified: 2025-08

Locations

FR(1)