Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2018-01-25
2019-01-21
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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with in-bag morcellation
with More-cell-Safe AMI bag morcellation
laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation
laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation
without any morcellation bag
without any morcellation bag
laparoscopic myomectomy or hysterectomy without any morcellation bag
laparoscopic myomectomy or hysterectomy without any morcellation bag
Interventions
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laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation
laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation
laparoscopic myomectomy or hysterectomy without any morcellation bag
laparoscopic myomectomy or hysterectomy without any morcellation bag
Eligibility Criteria
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Inclusion Criteria
* Laparoscopic myomectomy or laparoscopic subtotal hysterectomy
* Informed and signed consent
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Gautier CHENE, MD
Role: PRINCIPAL_INVESTIGATOR
Gynaecology Department, Hôpital Femme Mère Enfant, HCL
Locations
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Gynaecology Department, Hôpital Femme Mère Enfant
Bron, , France
Countries
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References
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Bensouda-Miguet C, Nohuz E, Cerruto E, Buenerd A, Nadaud B, Moret S, Chene G. Inbag Morcellation Applied to the Laparoscopic Surgery of Leiomyoma: A Randomized Controlled Trial. Biomed Res Int. 2021 May 26;2021:6611448. doi: 10.1155/2021/6611448. eCollection 2021.
Other Identifiers
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2017-A01773-50
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL16_0714
Identifier Type: -
Identifier Source: org_study_id
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