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 UMIN000016863
Receipt No. R000019573
Scientific Title A feasibility study of robot-assisted laparoscopic surgery for rectal cancer.
Date of disclosure of the study information 2015/04/01
Last modified on 2016/03/25

* 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 rectal cancer.
Acronym A feasibility study of robot-assisted laparoscopic surgery for rectal cancer.
Scientific Title A feasibility study of robot-assisted laparoscopic surgery for rectal cancer.
Scientific Title:Acronym A feasibility study of robot-assisted laparoscopic surgery for rectal cancer.
Region
Japan

Condition
Condition Rectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of robot-assisted rectal cancer surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The 30-day postoperative morbidity rate
Key secondary outcomes Success rate of robot-assisted laparoscopic surgery, Open conversion rate, Operative time, Blood loss, Number of lymph nodes harvested,R0 resection rate, local recurrence rate, relapse free survival, overall survival, urinary and sexual function

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 surgery 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 0-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. History of active double cancer within 5 years.
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 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Itaru Endo
Organization Yokohama City University
Division name Gastroenterological surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL 045-787-2800
Email endoit@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Ishibe
Organization Yokohama City University
Division name Gastroenterological surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japa
TEL 045-787-2800
Homepage URL
Email aishibe@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 01 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 03 Month 04 Day
Date of IRB
Anticipated trial start date
2015 Year 04 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 03 Month 21 Day
Last modified on
2016 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019573

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.