UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049435 |
|---|---|
| Receipt number | R000056141 |
| Scientific Title | Establishment of robot-assisted surgery for locally advanced uterine cancer. |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2022/11/05 06:27:54 |
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Basic information
Public title
Establishment of robot-assisted surgery for locally advanced uterine cancer.
Acronym
Establishment of robot-assisted surgery for locally advanced uterine cancer.
Scientific Title
Establishment of robot-assisted surgery for locally advanced uterine cancer.
Scientific Title:Acronym
Establishment of robot-assisted surgery for locally advanced uterine cancer.
Region
| Japan |
Condition
Condition
Uterus corpus cancer patient
(clinically FIGO stage IB and II of uterus corpus cancer).
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of a surgical technique suitable for Japanese women: feasibility of upper and lower abdominal operations with five ports placed in a straight line.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
feasibility of upper and lower abdominal operations with five ports placed in a straight line.
Key secondary outcomes
Intraoperative blood loss, operation time, percentage of patients who completed the planned surgery requiring an additional port, percentage of patients who are converted to laparotomy, postoperative pain, length of hospital stay, postoperative quality of life assessment, 5-year recurrence rate.
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
| Device,equipment |
Interventions/Control_1
Robot assisted laparoscopic surgery.
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
| 90 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Pathologically confirmed as primary uterus corpus cancer.
2. Clinically FIGO stage IB and II.
3. Age over 20 years.
4. Written informed consent was obtained.
Key exclusion criteria
1. Patients with other malignant diseases.
2. Patients who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding.
3. Patients with serous complications.
4. Patients who are judged to have difficulty participating in the study due to psychosis or psychiatric symptoms.
5. Patients with overt glaucoma.
6. Patients with untreated cerebral aneurysm.
7. Patients deemed inappropriate by the physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Mandai |
Organization
Graduate School of Medicine, Kyoto University
Division name
Gynecology and Obstetrics
Zip code
606-8507
Address
Shogoinkawahara-cho 54, Sakyo-ku, Kyoto city
TEL
+81-75-751-3269
mandai@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Yamanoi |
Organization
Graduate School of Medicine, Kyoto University
Division name
Gynecology and Obstetrics
Zip code
606-8507
Address
Shogoinkawahara-cho 54, Sakyo-ku, Kyoto city
TEL
+81-75-751-3269
Homepage URL
kojiymni@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
+81-75-753-4680
ethcom@kuhp.kyoto-u.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
| 2023 | Year | 04 | Month | 01 | 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
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | 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
| 2022 | Year | 11 | Month | 05 | Day |
Last modified on
| 2022 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056141
| 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 |
