UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017482 |
|---|---|
| Receipt number | R000020263 |
| Scientific Title | Safety of the robotically-assisted laparoscopic rectal surgery |
| Date of disclosure of the study information | 2015/05/11 |
| Last modified on | 2020/06/04 16:05:19 |
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Basic information
Public title
Safety of the robotically-assisted laparoscopic rectal surgery
Acronym
DaVinci-Rectum
Scientific Title
Safety of the robotically-assisted laparoscopic rectal surgery
Scientific Title:Acronym
DaVinci-Rectum
Region
| Japan |
Condition
Condition
cStage 0-I rectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assess the safety of robotically-assisted laparoscopic rectal cancer surgery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Overall adverse event occurrence rate
Key secondary outcomes
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
Robotically-assisted laparoscopic rectal cancer surgery will be performed on cStage 0-I rectal cancer patients.
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. cStage 0-I rectal cancer patient
2. ECOG Performance Status Scale: 0-1
3. Patient age of 20 year-old or over
4. Both male and female
5. The function of the main organ (bone marrow, heart, liver, kidney and lung, etc.) is maintained, and general anesthesia is enforceable
6. Written informed consent is obtained
Key exclusion criteria
1. Prior history of lower abdominal surgery
2. Complicated with intestinal obstruction
3. Emergency case
4. Pregnant case
5. Tumor size over 5cm in diameter
6. Tumor invaded to adjacent organ
7. Other conditions judged ineligible by physician
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Shinobu |
| Middle name | |
| Last name | Ohnuma |
Organization
Tohoku University Hospital
Division name
Department of Surgery
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-7205
sohnuma@surg.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shinobu |
| Middle name | |
| Last name | Ohnuma |
Organization
Tohoku University Hospital
Division name
Department of Surgery
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-7205
Homepage URL
sohnuma@surg.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Hospital
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
Institutional Review Board of Tohoku University Hospital
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
Tel
022-728-4105
ec@rinri.hosp.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | 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 | 05 | Month | 10 | Day |
Last modified on
| 2020 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020263
