UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013489
Receipt No. 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

* 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 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
Email 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
Email manabe@surg1.med.kyushu-u.ac.jp

Sponsor
Institute Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015756

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.