UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031530 |
|---|---|
| Receipt number | R000035842 |
| Scientific Title | A clinical study for robotic-assisted hysterectomy with da Vinci Surgical System |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2023/03/05 20:57:06 |
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Basic information
Public title
A clinical study for robotic-assisted hysterectomy with da Vinci Surgical System
Acronym
A clinical study for robotic-assisted hysterectomy with da Vinci Surgical System
Scientific Title
A clinical study for robotic-assisted hysterectomy with da Vinci Surgical System
Scientific Title:Acronym
A clinical study for robotic-assisted hysterectomy with da Vinci Surgical System
Region
| Japan |
Condition
Condition
Uterine fibroids
Uterine adenomyosis
Uterine prolapse
Otherwise benign uterine disease
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of robotic assisted hysterecomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total operating time
Key secondary outcomes
Console time
Amount of bleeding during the operation
Intraoperative complications
Postoperative complications
Hospital days
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
Robotic assisted hysterectomy performed with da Vinci surgical system
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 who have benign uterine disease for which hysterectomy is indicated.
2) Patient's BMI is lower than 35.
3) Patient's function of major organs (bone marrow, heart, lung, liver and kidneys) is good and suitable for the operation.
4) Patients who have received full explanations about the contents of the study and agreed to participate in the study, and who have submitted a written consent agreement.
Key exclusion criteria
1) Patients who have experienced more than three times of laparotomy.
2) Patients who have severe endometriosis.
3) Patients who have the uterus more than 15cm in diameter.
4) Patients who have mental disease or mental symptoms, difficult to participate to the study.
5) Patients who have brain aneurysm or glaucoma.
6) Patients who are judged ineligible by the principal investigator or sub-investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Nishii |
Organization
University Hospital, Mizonokuchi, Teikyo University School of Medicine
Division name
Obstetrics and Gynecology
Zip code
213-0002
Address
5-1-1, Futago, Takatsu-ku, Kawasaki City, Kanagawa
TEL
044-844-3333
nishii@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Tsuchiya |
Organization
University Hospital, Mizonokuchi, Teikyo University School of Medicine
Division name
Obstetrics and Gynecology
Zip code
213-0002
Address
5-1-1, Futago, Takatsu-ku, Kawasaki City, Kanagawa
TEL
044-844-3333
Homepage URL
tsuchiya@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
Teikyo University
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
Ethics Committee, Teikyo University
Address
2-11-1 Kaga Itabashi-ku Tokyo Japan
Tel
03-3964-7256
turb-office@teikyo-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
| 2018 | Year | 03 | 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
10
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
| 2018 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 01 | Day |
Last modified on
| 2023 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035842
