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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017482
Receipt No. 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

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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
Email 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
Email sohnuma@surg.med.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020263

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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