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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032950
Receipt No. R000037562
Official scientific title of the study Laparoscopic approach in high-risk patients
Date of disclosure of the study information 2018/06/11
Last modified on 2018/06/11

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Basic information
Official scientific title of the study Laparoscopic approach in high-risk patients
Title of the study (Brief title) Laparoscopy in high-risk patients
Region
Europe

Condition
Condition Women who require gynecological surgery that are classified as at high risk at the pre-surgical evaluation have significant morbidity.
Classification by specialty
Surgery in general Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Women who require gynecological surgery that are classified as at high risk at the pre-surgical evaluation have significant morbidity. The exact impact of presurgical conditions on the outcome is poorly investigated. The knowledges of the impact of each condition on the intrasurgical risk and postsurgical outcome is of great help in the preoperative assessment of the patient.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intraoperative data (operation time, blood loss, intraoperative complications, need for laparotomic conversion), postoperative data (fever, need for re-intervention, hospital stay) and readmission.
Key secondary outcomes

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
16 years-old <=
Age-upper limit
100 years-old >
Gender Female
Key inclusion criteria Indication to laparoscopic surgery
Key exclusion criteria Primary indication to vaginal, laparotomic, and hysteroscopic surgery
Target sample size 10000

Research contact person
Name of lead principal investigator Marco Scioscia
Organization Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy
Division name Obstetrics and Gynecology
Address Via Sempreboni 5 - 37024 Negrar (VR), Italy
TEL +393498724206
Email marcoscioscia@gmail.com

Public contact
Name of contact person Marco Scioscia
Organization Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy
Division name Obstetrics and Gynecology
Address Via Sempreboni 5 - 37024 Negrar (VR), Italy
TEL +393498724206
Homepage URL
Email marcoscioscia@gmail.com

Sponsor
Institute Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy
Institute
Department

Funding Source
Organization Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 Don Calabria Hospital, Negrar, Verona, Italy

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 11 Day

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 01 Month 04 Day
Anticipated trial start date
2015 Year 03 Month 03 Day
Last follow-up date
2015 Year 04 Month 18 Day
Date of closure to data entry
2015 Year 05 Month 02 Day
Date trial data considered complete
2015 Year 07 Month 15 Day
Date analysis concluded
2018 Year 04 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information This retrospective observational study evaluated all details of surgical complications according to pre-surgical conditions.

Management information
Registered date
2018 Year 06 Month 11 Day
Last modified on
2018 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037562

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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