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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040068
Receipt No. 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 2020/04/06

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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
Obsterics 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
Email 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
Email kohnishi@med.kitasato-u.ac.jp

Sponsor
Institute Kitasato University Hospital
Institute
Department

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
Email 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
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
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
2020 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045690

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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