UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040625 |
|---|---|
| Receipt number | 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 12:27:41 |
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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 | Obstetrics 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
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
marcoscioscia@gmail.com
Sponsor or person
Institute
Policlinico of Abano Terme
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046364
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
