UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040068 |
|---|---|
| Receipt number | R000045690 |
| Scientific Title | Clinical evaluation of the efficacy and safety of robot-assisted hysterectomy using da Vinci surgical system for benign gynecologic disease |
| Date of disclosure of the study information | 2020/04/06 |
| Last modified on | 2021/04/15 09:09:56 |
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Basic information
Public title
Clinical evaluation of the efficacy and safety of robot-assisted hysterectomy using da Vinci surgical system for benign gynecologic disease
Acronym
Clinical evaluation of the efficacy and safety of robot-assisted hysterectomy for benign gynecologic disease
Scientific Title
Clinical evaluation of the efficacy and safety of robot-assisted hysterectomy using da Vinci surgical system for benign gynecologic disease
Scientific Title:Acronym
Clinical evaluation of the efficacy and safety of robot-assisted hysterectomy for benign gynecologic disease
Region
| Japan |
Condition
Condition
Benign gynecologic disease such as uterine myomas, adenomyosis, etc.
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of robot-assisted hysterectomy using da Vinci surgical system for benign gynecologic disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of intra- and post-operative complications
Key secondary outcomes
Anesthesia time, operative time, estimated blood loss, postoperative analgesic requirements, length of hospital stay.
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 | Maneuver |
Interventions/Control_1
We perform robot-assisted hysterectomy using da Vinci surgical system for patients with benign gynecologic disease.
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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Patients with benign gynecologic disease such as uterine myomas, adenomyosis, etc.
2. Uterus is resectable with conventional laparoscopic surgery in size.
3. ECOG Performance Status 0 or 1.
4. Patients desire hysterectomy for treatment of disease.
5. Informed written consent is obtained.
Key exclusion criteria
1. BMI is over 30.
2. Patients with severe complications.
3. History of multiple pelvic surgeries or severe pelvic endometriosis.
4. History of glaucoma.
5. History of cerebrovascular disease.
6. Patients who are judged to be inappropriate as subject to this study by the investigators.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Haruko |
| Middle name | |
| Last name | Iwase |
Organization
Kitasato University Hospital
Division name
Gynecology
Zip code
252-0375
Address
1-15-1, Kitasato, Minami-ku, Sagamihara city, Kanagawa
TEL
0427788414
haiwase@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Kento |
| Middle name | |
| Last name | Ohnishi |
Organization
Kitasato University Hospital
Division name
Gynecology
Zip code
252-0375
Address
1-15-1, Kitasato, Minami-ku, Sagamihara city, Kanagawa
TEL
0427788414
Homepage URL
kohnishi@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kitasato University 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
The Kitasato Institute Clinical Research Review Board
Address
1-15-1, Kitasato, Minami-ku, Sagamihara city, Kanagawa
Tel
0427788273
rinrib@med.kitasato-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
北里大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 06 | 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
5
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | 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
| 2020 | Year | 04 | Month | 06 | Day |
Last modified on
| 2021 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045690
