Efficacy of In-bag Morcellation (FIBROSAC)

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)

Study Overview

• Status: Completed
• Conditions: Laparoscopy; Uterine Myomatosis; Hysterectomy, Vaginal
• Intervention / Treatment: Device: laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation; Procedure: laparoscopic myomectomy or hysterectomy without any morcellation bag

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Gynaecology Department, Hôpital Femme Mère Enfant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: with in-bag morcellation; with More-cell-Safe AMI bag morcellation	Device: laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation; laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation
ACTIVE_COMPARATOR: without any morcellation bag	Procedure: laparoscopic myomectomy or hysterectomy without any morcellation bag; laparoscopic myomectomy or hysterectomy without any morcellation bag

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
ease of use	assessment by a visual analogical scale	Day 0 - during surgery

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Gautier CHENE, MD, Gynaecology Department, Hôpital Femme Mère Enfant, HCL

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2018
• Primary Completion (ACTUAL): January 21, 2019
• Study Completion (ACTUAL): January 21, 2019

Study Registration Dates

• First Submitted: September 11, 2017
• First Submitted That Met QC Criteria: September 11, 2017
• First Posted (ACTUAL): September 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Laparoscopy; Morcellation; Hysterectomy, Vaginal; Uterine Myomatosis; in-bag morcellation
• Other Study ID Numbers: 69HCL16_0714; 2017-A01773-50 (OTHER: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No