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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014310
Receipt No. R000016662
Scientific Title Prevalence of uterine sarcoma during myomectomy
Date of disclosure of the study information 2014/06/30
Last modified on 2014/06/18

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Basic information
Public title Prevalence of uterine sarcoma during myomectomy
Acronym Prevalence of uterine sarcoma during myomectomy
Scientific Title Prevalence of uterine sarcoma during myomectomy
Scientific Title:Acronym Prevalence of uterine sarcoma during myomectomy
Region
Europe

Condition
Condition Uterine leiomyomas are extremely common and frequently require surgery. A rare but potentially devastating consequence of myomectomy is inadvertent incomplete resection of a uterine sarcoma, resulting in tumor dissemination and a worse prognosis.
Classification by specialty
Surgery in general Obsterics and gynecology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study was to evaluate the incidence of uterine sarcomas during myomectomy
Basic objectives2 Others
Basic objectives -Others Prevalence of disease
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Prevalence of sarcomas in myomectomy and hysterectomy
Key secondary outcomes Prevalence of sarcomas among removed fibroids

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <
Age-upper limit
80 years-old >
Gender Female
Key inclusion criteria All consecutive cases of myomectomy and hysterectomy performed over 10 years
Key exclusion criteria Known malignanciy before surgery
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Marco Scioscia
Organization Sacro Cuore General Hospital
Division name Obstetrics and Gynecology
Zip code
Address Via Sempreboni 5, Negrar, Verona, Italy
TEL +81-0393498724206
Email marcoscioscia@gmai.com

Public contact
Name of contact person
1st name
Middle name
Last name Marco Scioscia
Organization Sacro Cuore Don Calabria
Division name Obstetrics and Gynecology
Zip code
Address Via Sempreboni 5, Negrar, Verona, Italy
TEL +81-0393498724206
Homepage URL
Email marco.scioscia@sacrocuore.it

Sponsor
Institute Sacroc Cuore General Hospital
Institute
Department

Funding Source
Organization Self Funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions Sacro Cuore General Hospital, Via Sempreboni 5, Negrar, Verona, Italy

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The main aim of this study was to evaluate the prevalence of sarcomas among all myomectomies and hysterectomies carried out in our hospital over 10 years. Our hospital is a referral center for gynecological surgery.

Management information
Registered date
2014 Year 06 Month 18 Day
Last modified on
2014 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016662

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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