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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030371
Receipt No. R000034674
Scientific Title An evaluation study of efficacy and safety of Robotic low anterior resection with da Vinci Surgical System for rectal cancer
Date of disclosure of the study information 2017/12/15
Last modified on 2018/04/10

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Basic information
Public title An evaluation study of efficacy and safety of Robotic low anterior resection with da Vinci Surgical System for rectal cancer
Acronym An evaluation of Robotic low anterior resection with da Vinci
Scientific Title An evaluation study of efficacy and safety of Robotic low anterior resection with da Vinci Surgical System for rectal cancer
Scientific Title:Acronym An evaluation of Robotic low anterior resection with da Vinci
Region
Japan

Condition
Condition rectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of Robotic low anterior resection using da Vinci Surgical System for rectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Perioperative Morbidity and Mortality (Clavien-Dindo classification over Grade II)
Key secondary outcomes Surgical outcomes (operation time, volume of blood loss, and conversion rate to open surgery)

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 Robotic low anterior resection 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 Male and Female
Key inclusion criteria 1) histrogically and radiologically judged rectal cancer
2) applicable to laparoscopic low anterior resection
3) age 20 to 80 years
4) ECOG-Performance status of 0 to 1
5) written informed consent
Key exclusion criteria 1) severe cardiac or cerebral vascular disease
2) aspirin, warfarin or other medications induce bleeding tendency prohibited to discontinue
3) sever renal disfunction
4) severe hepatic disfunction
5) patients whose enrollement in this trial is judged to be inappropriate by the attending doctor.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihisa Sakaguchi
Organization National Hospital Organization Kyushu Medical Center
Division name Department of Gastroenterological Surgery
Zip code
Address 1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan
TEL 092-852-0700
Email ysakaguchi@kyumed.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihisa Sakaguchi
Organization National Hospital Organization Kyushu Medical Center
Division name Department of Gastroenterological Surgery
Zip code
Address 1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan
TEL 092-852-0700
Homepage URL
Email ysakaguchi@kyumed.jp

Sponsor
Institute National Hospital Organization Kyushu Medical Center
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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
2017 Year 12 Month 15 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 Completed
Date of protocol fixation
2013 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 12 Day
Last modified on
2018 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034674

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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