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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019857
Receipt No. R000022940
Scientific Title The safety and feasibility of robotically-assisted laparoscopic rectal cancer surgery using da Vinci Surgical System
Date of disclosure of the study information 2015/11/20
Last modified on 2015/11/19

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Basic information
Public title The safety and feasibility of robotically-assisted laparoscopic rectal cancer surgery using da Vinci Surgical System
Acronym The safety and feasibility of robotically-assisted laparoscopic rectal cancer surgery
Scientific Title The safety and feasibility of robotically-assisted laparoscopic rectal cancer surgery using da Vinci Surgical System
Scientific Title:Acronym The safety and feasibility of robotically-assisted laparoscopic rectal cancer surgery
Region
Japan

Condition
Condition Rectal cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of safety and feasibility of robotically-assisted laparoscopic rectal cancer surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes Rate of conversion from laparoscopic surgery to open surgery
Key secondary outcomes Rate of the incidence of postoperative complications further than Grade2 of Clavien-Dindo classification
incidence of intra-operative complications
QOL, sexual and urinary function
Postoperative morbidity and short terms outcomes
Local recurrence rates at three years
Disease free survival
Overall survival
In-hospital mortality

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 Robot assisted laparoscopic rectal surgery
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 Rectal cancer
Patients expected to undergo radical excision
Performance status (PS;ECOG) is 0 or 1
Written informed consent
Key exclusion criteria Any metastasis
The case that the high adhesion is predicted
The case that the medical attendant judged to be inappropriate
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kazunori Takeda
Organization National Hospital Organization, Sendai Medical Center
Division name Department of Surgery
Zip code
Address 2-8-8Miyagino,Miyagino-ku,Sendai,Miyagi
TEL 022-293-1111
Email kktakeda@snh.go.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Hiroshi Oshio
Organization National Hospital Organization, Sendai Medical Center
Division name Department of Surgery
Zip code
Address 2-8-8Miyagino,Miyagino-ku,Sendai,Miyagi
TEL 022-293-1111
Homepage URL
Email hoshio981@snh.go.jp

Sponsor
Institute National Hospital Organization, Sendai Medical Center
Institute
Department

Funding Source
Organization None
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
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
2015 Year 11 Month 20 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 Open public recruiting
Date of protocol fixation
2015 Year 09 Month 17 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 01 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
2015 Year 11 Month 19 Day
Last modified on
2015 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022940

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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