Intracorporeal Versus Extracorporeal Morcellation: Clinical Efficacy and Safety Outcomes
NCT ID: NCT02086435
Last Updated: 2015-04-21
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
93 participants
INTERVENTIONAL
2014-03-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Extracorporeal morcellation
Extracorporeal morcellation in which patients are treated with "protected" removal by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself
Extracorporeal morcellation
patients treated with "protected" removal by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself
Intracorporeal morcellation
Intracorporeal morcellation patients treated with standard intracorporeal morcellation, using reusable electronic device
Intracorporeal morcellation
patients treated with standard intracorporeal morcellation, using reusable electronic device
Interventions
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Extracorporeal morcellation
patients treated with "protected" removal by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself
Intracorporeal morcellation
patients treated with standard intracorporeal morcellation, using reusable electronic device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of at least one uterine myoma larger than 4 cm
* Aged between 18 and 40 years
Exclusion Criteria
* Medical major disorders associated
* Acute or chronic psychiatric disorders
* Ascertained Premenstrual syndrome
* Use of drugs that can affect cognitive ability or state of consciousness and alertness during the last six months prior to enrollment
* Presence of calcified fibroids ultrasound examination
* Presence of adnexal lesions
* Detection of a pattern of endometrial hyperplasia with atypia determined in the course endometrial biopsy performed for abnormal uterine bleeding
* Abnormal PAP test
* Positive Pregnancy Test
* Previous use of laparoscopic surgery increased
18 Years
40 Years
FEMALE
Yes
Sponsors
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University Magna Graecia
OTHER
Responsible Party
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Fulvio Zullo
Full Professor Obstetric Gynecology
Principal Investigators
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Fulvio Zullo
Role: PRINCIPAL_INVESTIGATOR
Magna Graecia University of Catanzaro
Locations
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Chair of Obstetrics and Gynecology - University division - UMG
Catanzaro, CZ, Italy
Countries
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References
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Venturella R, Rocca ML, Lico D, La Ferrera N, Cirillo R, Gizzo S, Morelli M, Zupi E, Zullo F. In-bag manual versus uncontained power morcellation for laparoscopic myomectomy: randomized controlled trial. Fertil Steril. 2016 May;105(5):1369-1376. doi: 10.1016/j.fertnstert.2015.12.133. Epub 2016 Jan 19.
Other Identifiers
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SafeMorcellation
Identifier Type: -
Identifier Source: org_study_id
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