UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013489 |
|---|---|
| Receipt number | R000015756 |
| Scientific Title | A Feasibility Study of Robot-Assisted Laparoscopic Surgery for the Treatment of Colorectal Cancers |
| Date of disclosure of the study information | 2014/03/24 |
| Last modified on | 2016/10/13 09:59:28 |
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Basic information
Public title
A Feasibility Study of Robot-Assisted Laparoscopic Surgery for the Treatment of Colorectal Cancers
Acronym
A Feasibility Study of Robot-Assisted Laparoscopic Surgery for the Colorectal Cancers
Scientific Title
A Feasibility Study of Robot-Assisted Laparoscopic Surgery for the Treatment of Colorectal Cancers
Scientific Title:Acronym
A Feasibility Study of Robot-Assisted Laparoscopic Surgery for the Colorectal Cancers
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the safety and efficacy of robot-assisted laparoscopic surgery for the colorectal cancers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraoperative and postoperative morbidity rate, Ro resection rate
Key secondary outcomes
Treatment rate of robot-assisted laparoscopic surgery, Open conversion rate, Operative time, Blood loss, Number of lymph nodes harvested, Local recurrence rate, Overall survival, Relapse-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
Robot-assisted laparoscopic operation using "da Vinci Surgical System" will be performed.
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
1. Colorectal cancer proven histologically.
2. Resectable stage I-III tumor.
3. No prior chemotherapy or radiotherapy for colorectal cancer.
4. ECOG PS 0-1.
5. Age 20-80.
6. Adequate organ function to perform the surgery.
7. Written informed consent.
Key exclusion criteria
1. Tumor with over 5cm in the maximum diameter.
2. Direct invasion into the surrounding organ.
3. Ileus.
4. Infectious disease in abdominal cavity.
5. Diffuse adhesion anticipated.
6. Serious co-morbidity, such as cardiopulmonary disease, bleeding tendency, uncontrollable diabetes mellitus or hypertension.
7. Pregnant or possibly pregnant women.
8. Other conditions judged ineligible by physician.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Nakamura,MD |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Surgery and Oncology
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka, 812-8582, Japan
TEL
092-642-5437
mnaka@surg1.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Manabe,MD |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Surgery and Oncology
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka,
TEL
092-642-5440
Homepage URL
manabe@surg1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
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
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 24 | 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
| 2013 | Year | 05 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 25 | 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
| 2014 | Year | 03 | Month | 23 | Day |
Last modified on
| 2016 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015756
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
