Status:
COMPLETED
Efficacy of In-bag Morcellation
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Uterine Myomatosis
Laparoscopy
Eligibility:
FEMALE
18+ years
Phase:
NA
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 Admi...
Eligibility Criteria
Inclusion
- Women aged 18 years or more
- Laparoscopic myomectomy or laparoscopic subtotal hysterectomy
- Informed and signed consent
Exclusion
- 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
Key Trial Info
Start Date :
January 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2019
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03281460
Start Date
January 25 2018
End Date
January 21 2019
Last Update
September 2 2025
Active Locations (1)
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1
Gynaecology Department, Hôpital Femme Mère Enfant
Bron, France, 69500