UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032950 |
|---|---|
| Receipt number | R000037562 |
| Scientific Title | Laparoscopic approach in high-risk patients |
| Date of disclosure of the study information | 2018/06/11 |
| Last modified on | 2018/06/11 17:36:15 |
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Basic information
Public title
Laparoscopic approach in high-risk patients
Acronym
Laparoscopy in high-risk patients
Scientific Title
Laparoscopic approach in high-risk patients
Scientific Title:Acronym
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 | Obstetrics 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
| 1st name | |
| Middle name | |
| Last name | Marco Scioscia |
Organization
Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy
Division name
Obstetrics and Gynecology
Zip code
Address
Via Sempreboni 5 - 37024 Negrar (VR), Italy
TEL
+393498724206
marcoscioscia@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Marco Scioscia |
Organization
Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy
Division name
Obstetrics and Gynecology
Zip code
Address
Via Sempreboni 5 - 37024 Negrar (VR), Italy
TEL
+393498724206
Homepage URL
marcoscioscia@gmail.com
Sponsor or person
Institute
Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2015 | Year | 01 | Month | 04 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037562
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
