UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000029118
Receipt No. R000033301
Scientific Title Prospective study of robotic assisted rectal cancer surgery
Date of disclosure of the study information 2017/10/01
Last modified on 2019/08/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prospective study of robotic assisted rectal cancer surgery
Acronym Prospective study of roboticrectal cancer surgery
Scientific Title Prospective study of robotic assisted rectal cancer surgery
Scientific Title:Acronym Prospective study of roboticrectal cancer surgery
Region
Japan

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

Objectives
Narrative objectives1 Safety and efficacy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Complication rate
Key secondary outcomes Conversion rate
3year recurrence free survival

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 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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Adenocarcinoma
2.Tumor is located in the rectum
3.cStage 0-IIIb
4.Contraindication of endoscopic resection
5.Age 20 or older
6.PS 0/1
7.Adequate organ function
8.Informed consent
Key exclusion criteria 1.In hope of open or laparoscopic surgery
2.Multiple cancer
3.Multicentric colorectal cancer
4.Ileus
5.Past history of bowel resection
6.Uncontrorable comorbidity
7.Unsuitable patients
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Eigo
Middle name
Last name Otsuji
Organization Kyoto Prefectural University of Medicine
Division name Digestive Surgery
Zip code 602-8566
Address 465, Kajii-cho, Kamigyoku, Kyoto city
TEL 075-251-5527
Email mnakan@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Masayoshi
Middle name
Last name Nakanishi
Organization Kyoto Prefectural University of Medicine
Division name Digestive Surgery
Zip code 602-8566
Address 465, Kajii-cho, Kamigyoku, Kyoto city
TEL 075-251-5527
Homepage URL
Email mnakan@koto.kpu-m.ac.jp

Sponsor
Institute kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
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 Kyoto Prefectural University of Medicine
Address 465, Kajii-cho, Kamigyoku, Kyoto city
Tel 075-251-5527
Email 075-251-5522

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 10 Month 01 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 Suspended
Date of protocol fixation
2017 Year 10 Month 01 Day
Date of IRB
2014 Year 02 Month 14 Day
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
2018 Year 06 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 12 Day
Last modified on
2019 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033301

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.