UMIN-CTR Clinical Trial

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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