UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049504 |
|---|---|
| Receipt number | R000056373 |
| Scientific Title | Clinical study to investigate the usefulness and safety of robot-assisted laparoscopic surgery for malignant uterine tumors using the da Vinci Si Surgical System |
| Date of disclosure of the study information | 2022/11/15 |
| Last modified on | 2024/12/25 16:39:35 |
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Basic information
Public title
Clinical study to investigate the usefulness and safety of robot-assisted laparoscopic surgery for malignant uterine tumors using the da Vinci Si Surgical System
Acronym
Clinical study to investigate the usefulness and safety of robot-assisted laparoscopic uterine malignancy surgery
Scientific Title
Clinical study to investigate the usefulness and safety of robot-assisted laparoscopic surgery for malignant uterine tumors using the da Vinci Si Surgical System
Scientific Title:Acronym
Clinical study to investigate the usefulness and safety of robot-assisted laparoscopic uterine malignancy surgery
Region
| Japan |
Condition
Condition
Cervical cancer, uterine cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The usefulness and safety of robot-assisted laparoscopic surgery for uterine malignancies and safety of robot-assisted laparoscopic surgery for uterine malignancies
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
complication rate
Key secondary outcomes
Postoperative hospital mortality, incidence of intraoperative complications, intraoperative blood loss, operative time, incidence of all postoperative complications, histopathological evaluation of resected margins
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
Through March 31, 2028
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) Cases of uterine malignancy requiring radical surgery
(2) Cases in which radical resection is expected
(3) Patients who are between 20 and 80 years old at the time of surgery
(4) Patients with PS (ECOG): 0 or 1
(5) Patients who have given written consent for the surgery
Key exclusion criteria
(1) Patients with distant metastasis to other organs or peritoneal dissemination
(2) Patients who have previously undergone intraperitoneal surgery for other diseases and are expected to have severe adhesions
(3) Other cases deemed inappropriate by the physician in charge
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kota |
| Middle name | |
| Last name | Umemura |
Organization
Toyohashi Municipal Hospital
Division name
Gynecology
Zip code
441
Address
50 Aza Hachiken-nishi, Aotake-cho, Toyohashi, Aichi, Japan
TEL
09013832448
umemura-kota@toyohashi-mh.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Umemura |
Organization
Toyohashi Municipal Hospital
Division name
Gynecology
Zip code
441-8570
Address
50 Aza Hachiken-nishi, Aotake-cho, Toyohashi, Aichi, Japan
TEL
0532336111
Homepage URL
umemura-kota@toyohashi-mh.jp
Sponsor or person
Institute
Toyohashi Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Toyohashi Municipal Hospital
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
Toyohashi Municipal Hospital
Address
50 Aza Hachiken-nishi, Aotake-cho, Toyohashi, Aichi, Japan
Tel
0532336111
umemura-kota@toyohashi-mh.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
| 2022 | Year | 11 | Month | 15 | Day |
Related information
URL releasing protocol
https://www.municipal-hospital.toyohashi.aichi.jp/department/naishikyo_geka/
Publication of results
Unpublished
Result
URL related to results and publications
https://www.municipal-hospital.toyohashi.aichi.jp/department/naishikyo_geka/
Number of participants that the trial has enrolled
30
Results
Compared to laparotomy, the amount of bleeding is reduced and the length of hospital stay is shortened.
Results date posted
| 2024 | Year | 12 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with cervical cancer or endometrial cancer aged 20 to 75
Participant flow
This is performed on patients who wish to have robotic surgery for the target diseases
Adverse events
None in particular
Outcome measures
Operating time, amount of bleeding, complications, length of hospital stay
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2023 | 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 | 15 | Day |
Last modified on
| 2024 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056373
