UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000020263