Efficacy of In-bag Morcellation

Laparoscopy Clinical Trial

— FIBROSAC  

Official title:

Efficacy of In-bag Morcellation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03281460
• Other study ID #: 69HCL16_0714
• Secondary ID: 2017-A01773-50
• Status: Completed
• Phase: N/A
• Start date: January 25, 2018
• Est. completion date: January 21, 2019

Study information

• Verified date: January 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 21, 2019
• Est. primary completion date: January 21, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hysterectomy, Vaginal
• Laparoscopy
• Uterine Myomatosis

Intervention

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

Locations

Country	Name	City	State
France	Gynaecology Department, Hôpital Femme Mère Enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	duration of surgery		Day 0
Secondary	morcellation time		Day 0 - during surgery
Secondary	peritoneal washing time		Day 0 - during surgery
Secondary	residual morcellated tissues weight		Day 0 - during surgery
Secondary	bag associated time		Day 0 - during surgery
Secondary	ease of use	assessment by a visual analogical scale	Day 0 - during surgery