Efficacy of In-bag Morcellation

Not Applicable

Completed

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

• Registration Number: NCT03281460
• Lead Sponsor: Hospices Civils de Lyon

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-11
• Study First Submitted QC: 2017-09-11
• Study First Posted: 2017-09-13
• Study Start: 2018-01-25
• Status Verified: 2019-01
• Primary Completion: 2019-01-21
• Study Completion: 2019-01-21
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
with in-bag morcellation	laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation	with More-cell-Safe AMI bag morcellation
without any morcellation bag	laparoscopic myomectomy or hysterectomy without any morcellation bag	without any morcellation bag

Primary Outcome Measures

Name	Time	Method
Smooth muscular cells in the peritoneal fluid after morcellation	Day 0 - just after surgery	After morcellation, there will be cytology and immunohistochemistry of peritoneal washing with 500cc of saline serum

Secondary Outcome Measures

Name	Time	Method
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	Day 0 - during surgery	assessment by a visual analogical scale

Trial Locations

Locations (1)

Gynaecology Department, Hôpital Femme Mère Enfant; 🇫🇷 Bron, France