UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016203 |
|---|---|
| Receipt number | R000018801 |
| Scientific Title | Prospective study of robotic assisted rectal cancer surgery using the da Vinci Surgical System |
| Date of disclosure of the study information | 2015/01/13 |
| Last modified on | 2018/09/27 11:13:49 |
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Basic information
Public title
Prospective study of robotic assisted rectal cancer surgery using the da Vinci Surgical System
Acronym
Prospective study of roboticrectal cancer surgery
Scientific Title
Prospective study of robotic assisted rectal cancer surgery using the da Vinci Surgical System
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
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complication rate
Key secondary outcomes
Operative time, Blood loss, Pstoperative hospital stay, Conversion rate
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 | |
| Middle name | |
| Last name | Masato Nagino |
Organization
Nagoya University Gratuated School of Medicine
Division name
Division of Surgical Oncology, Department of Surgery
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya
TEL
052-744-2222
kuehara@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisuke Uehara |
Organization
Nagoya University Gratuated School of Medicine
Division name
Division of Surgical Oncology, Department of Surgery
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya
TEL
052-744-2222
Homepage URL
kuehara@med.nagoya-u.ac.jp
Sponsor or person
Institute
Division of Surgical Oncology, Department of Surgery, Nagoya University Gratuated School of Medicine
Institute
Department
Personal name
Funding Source
Organization
No
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
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 | 01 | Month | 13 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 01 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | 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 | 01 | Month | 13 | Day |
Last modified on
| 2018 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018801
