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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040625
Receipt No. R000046364
Scientific Title Clinical and surgical outcomes of deep infiltrating endometriosis
Date of disclosure of the study information 2020/06/02
Last modified on 2020/06/02

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Basic information
Public title Clinical and surgical outcomes of deep infiltrating endometriosis
Acronym CASODIE
Scientific Title Clinical and surgical outcomes of deep infiltrating endometriosis
Scientific Title:Acronym CASODIE
Region
Europe

Condition
Condition Pelvic endometriosis
Classification by specialty
Medicine in general Gastroenterology Surgery in general
Gastrointestinal surgery Obsterics and gynecology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clinical and surgical outcomes of laparoscopic surgery for endometriosis
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety and incidence of complications of surgery for deep infiltrating endometriosis
Key secondary outcomes Surgical details assessment

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
90 years-old >=
Gender Female
Key inclusion criteria Histological evidence of endometriosis
Key exclusion criteria Absence of endometriosis
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Marco
Middle name
Last name Scioscia
Organization Policlinico Hospital of Abano Terme
Division name Dpt Obstetrics and Gynecology
Zip code 35031
Address Piazza Cristoforo Colombo 1
TEL 00393498724206
Email marcoscioscia@gmail.com

Public contact
Name of contact person
1st name Marco
Middle name
Last name Scioscia
Organization Policlinico Hospital of Abano Terme, Padua, Italy
Division name Dpt Obstetrics and Gynecology
Zip code 35031
Address Piazza Cristoforo Colombo 1
TEL 00393498724206
Homepage URL
Email marcoscioscia@gmail.com

Sponsor
Institute Policlinico of Abano Terme
Institute
Department

Funding Source
Organization Policlinico Hospital of Abano Terme
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Policlinico Hospital
Address P.zza C. Colombo 1 Abano Terme PD
Tel 00390498221211
Email mscioscia@casacura.it

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

Other administrative information
Date of disclosure of the study information
2020 Year 06 Month 02 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 Preinitiation
Date of protocol fixation
2020 Year 04 Month 06 Day
Date of IRB
Anticipated trial start date
2020 Year 06 Month 01 Day
Last follow-up date
2020 Year 06 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Data of surgical details and clinical outcomes are retrieved from the internal database.

Management information
Registered date
2020 Year 06 Month 02 Day
Last modified on
2020 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046364

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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