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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

Tracking Information
First Submitted Date  ICMJE September 11, 2017
First Posted Date  ICMJE September 13, 2017
Last Update Posted Date February 1, 2019
Actual Study Start Date  ICMJE January 25, 2018
Actual Primary Completion Date January 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2017)
  • duration of surgery [ Time Frame: Day 0 ]
  • morcellation time [ Time Frame: Day 0 - during surgery ]
  • peritoneal washing time [ Time Frame: Day 0 - during surgery ]
  • residual morcellated tissues weight [ Time Frame: Day 0 - during surgery ]
  • bag associated time [ Time Frame: Day 0 - during surgery ]
  • ease of use [ Time Frame: Day 0 - during surgery ]
    assessment by a visual analogical scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of In-bag Morcellation
Official Title  ICMJE Efficacy of In-bag Morcellation
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Uterine Myomatosis
  • Laparoscopy
  • Hysterectomy, Vaginal
Intervention  ICMJE
  • Device: laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation
    laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation
  • Procedure: laparoscopic myomectomy or hysterectomy without any morcellation bag
    laparoscopic myomectomy or hysterectomy without any morcellation bag
Study Arms  ICMJE
  • Experimental: with in-bag morcellation
    with More-cell-Safe AMI bag morcellation
    Intervention: Device: laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation
  • Active Comparator: without any morcellation bag
    without any morcellation bag
    Intervention: Procedure: laparoscopic myomectomy or hysterectomy without any morcellation bag
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2017)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 21, 2019
Actual Primary Completion Date January 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03281460
Other Study ID Numbers  ICMJE 69HCL16_0714
2017-A01773-50 ( Other Identifier: ID-RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gautier CHENE, MD Gynaecology Department, Hôpital Femme Mère Enfant, HCL
PRS Account Hospices Civils de Lyon
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP