UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019857 |
|---|---|
| Receipt number | 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 12:45:16 |
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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
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
kktakeda@snh.go.jp
Public contact
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
hoshio981@snh.go.jp
Sponsor or person
Institute
National Hospital Organization, Sendai Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022940
