Skip to main content
OpenTrials
Completed

NCT Number: NCT03281460

Efficacy of In-bag Morcellation

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Uterine Myomatosis Hysterectomy, Vaginal Laparoscopy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gynaecology Department, Hôpital Femme Mère Enfant

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

laparoscopic myomectomy or hysterectomy without any morcellation bag

Procedure

laparoscopic myomectomy or hysterectomy without any morcellation bag

Primary outcomes

  1. Smooth muscular cells in the peritoneal fluid after morcellation

    Time frame: Day 0 - just after surgery

    After morcellation, there will be cytology and immunohistochemistry of peritoneal washing with 500cc of saline serum

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

    Time frame: Day 0 - during surgery

    assessment by a visual analogical scale

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: FIBROSAC

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 13, 2017
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.