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Efficacy of In-bag Morcellation (FIBROSAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03281460
Recruitment Status : Completed
First Posted : September 13, 2017
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
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)


Condition or disease Intervention/treatment Phase
Uterine Myomatosis Laparoscopy Hysterectomy, Vaginal Device: laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation Procedure: laparoscopic myomectomy or hysterectomy without any morcellation bag Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of In-bag Morcellation
Actual Study Start Date : January 25, 2018
Actual Primary Completion Date : January 21, 2019
Actual Study Completion Date : January 21, 2019

Resource links provided by the National Library of Medicine


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
without any morcellation bag
Procedure: laparoscopic myomectomy or hysterectomy without any morcellation bag
laparoscopic myomectomy or hysterectomy without any morcellation bag




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281460


Locations
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France
Gynaecology Department, Hôpital Femme Mère Enfant
Bron, France, 69500
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Gautier CHENE, MD Gynaecology Department, Hôpital Femme Mère Enfant, HCL
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03281460    
Other Study ID Numbers: 69HCL16_0714
2017-A01773-50 ( Other Identifier: ID-RCB )
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Hysterectomy, Vaginal
Uterine Myomatosis
Morcellation
Laparoscopy
in-bag morcellation