UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053851 |
|---|---|
| Receipt number | R000061462 |
| Scientific Title | Introduction of robot-assisted hysterectomy for uterine cancer |
| Date of disclosure of the study information | 2024/03/13 |
| Last modified on | 2024/03/13 16:26:57 |
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Basic information
Public title
Introduction of robot-assisted hysterectomy for uterine cancer
Acronym
robot-assisted hysterectomy for uterine cancer
Scientific Title
Introduction of robot-assisted hysterectomy for uterine cancer
Scientific Title:Acronym
robot-assisted hysterectomy for uterine cancer
Region
| Japan |
Condition
Condition
uterine cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of Robot-assisted hysterectomy for uterine cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the safety and efficacy of robot-assisted hysterectomy for uterine cancer
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Robotic-Assisted Hysterectomy for uterine cancer
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Patients with a clinical diagnosis of uterine cancer and all of the following
-The lesion must be confined to the uterine body and within 1/2 of myometrial invasion (FIGO stage IA).
-Patients with endometrial carcinoma of the endometrial histology.
-Patients with endometrial carcinoma of differentiated or moderately differentiated type by endometrial histology
(2) Patients who have been fully informed of the treatment (surgery) and have given their consent (including consent for annual reporting to the Japan Society of Obstetrics and Gynecology, which is mandatory for the facility performing the surgery).
(3) Patients with ECOG Performance Status 0-1
(4) Patients who can undergo general anesthesia
(5) Patients who can undergo laparoscopic surgery
Key exclusion criteria
(1) Patients under 20 years of age and over 80 years of age
(2) Patients whose judgment ability seems to be inadequate.
(3) Patients for whom vaginal retrieval of the uterus is considered difficult by internal examination and diagnostic imaging.
(4) Patients with severe adhesions
(5) Patients with severe obesity
(6) Patients with a history of abdominal surgery that is considered difficult to perform laparoscopically
(7) Patients with abdominal aortic aneurysm
(8) Patients with cerebrovascular disorder (subarachnoid hemorrhage, cerebral infarction, transient ischemic attack, etc.)
(9) Patients with severe glaucoma
(10) Women who are pregnant or may become pregnant
(11) Patients who wish to preserve their fertility.
(12) Patients with other serious complications that make this study (this procedure) difficult in the surgeon's judgment.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Nagayoshi |
Organization
International University of Health and Welfare, Mita Hospital
Division name
Gynecologic Oncology Center / Gynecology
Zip code
1088329
Address
1-4-3 Mita, Minatoku, Tokyo 108-8329, Japan
TEL
0334518121
y-nagayoshi@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Nagayoshi |
Organization
International University of Health and Welfare, Mita Hospital
Division name
Gynecologic Oncology Center / Gynecology
Zip code
108-8329
Address
1-4-3 Mita, Minatoku, Tokyo 108-8329, Japan
TEL
0334518121
Homepage URL
y-nagayoshi@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
no cost
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
International University of Health and Welfare, Mita Hospital
Address
1-4-3 Mita, Minato-ku Tokyo, 108-8329 JAPAN
Tel
0334518121
y-nagayoshi@iuhw.ac.jp
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
| 2024 | Year | 03 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 13 | Day |
Last modified on
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061462
| Research Plan | |
|---|---|
| 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 |
