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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000015436
Receipt No. R000017950
Scientific Title Clinical study of the safety of the da Vinci operation system for rectal cancer and its effectiveness on functional preservation
Date of disclosure of the study information 2014/11/01
Last modified on 2019/04/18

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Basic information
Public title Clinical study of the safety of the da Vinci operation system for rectal cancer and its effectiveness on functional preservation
Acronym Clinical study of the safety of the da Vinci operation system for rectal cancer and its effectiveness on functional preservation
Scientific Title Clinical study of the safety of the da Vinci operation system for rectal cancer and its effectiveness on functional preservation
Scientific Title:Acronym Clinical study of the safety of the da Vinci operation system for rectal cancer and its effectiveness on functional preservation
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 effectiveness of robot assisted surgery for curative rectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Urinary dysfunction
Key secondary outcomes (1) Rate of anastomotic leakage
(2) Erectile dysfunction
(3) Defecatory dysfunction
(4) Stress assessment of surgeon
(5) Operation time
(6) Completion rate of robot assisted surgery
(7) Overall survival
(8) Disease free survival
(9) Other side effects (exclude (1))

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 The rectal cancer operation by the robot assisted surgery using the da Vinci operation system
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) Patients will undergo low anterior resection for rectal cancer.
(2) Patients expected to be curatively A.
(3) performance Status (ECOG) is either 0 or 1.
(4) BMI (body mass index) is under 30.
(5) Patients who fulfill all the conditions listed below
A) WBC level is greater or equal to 3,000/mm^3.
B) PLT level is greater or equal to 100,000/mm^3.
C) AST and ALT level are less than or equal to 100 IU/L.
D) T-Bil level are less than 2.0 g/dl.
E) Serum creatinine level are less than 1.5mg/dl.
(6) All details have been explained thoroughly to patients, and they have a full understanding of the study. Patients have agreed to participate in the study of their own will and have signed the letter of consent.
Key exclusion criteria Patients
(1) who will undergo neo-adjuvant chemo-radiotherapy, or lateral pelvic lymph node dissection.
(2) with distant metastasis or dissemination
(3) with bulky tumor, that is over 5cm in diameter
(4) who who have undergone previous abdominal surgery, and developed severe abdominal adhesion.
(5) active multiple cancer
(6) who are or may be pregnant. Also, patients are or lactating.
(7) with psychosis
(8) prolonged steroid use
(9) who had cardiac infarction, or angina within 6 months.
(10) with uncontrolled blood pressure
(11) with diabetes mellitus and are using insulin, or with uncontrolled diabetes mellitus
(12) with respiratory disease who need a continuous oxygen supply
(13) patient who have been determined as inappropriate by the person in charge of the research.
Target sample size 26

Research contact person
Last name of lead principal investigator
1st name Masakazu
Middle name
Last name Yamamoto
Organization Tokyo Women's Medical University
Division name Department of Surgery, Institute of Gastroenterology
Zip code 162-8666
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Email yamamoto.ige@twmu.ac.jp

Public contact
1st name of contact person
1st name Takeshi
Middle name
Last name Ohki
Organization Tokyo Women's Medical University
Division name Department of Surgery, Institute of Gastroenterology
Zip code 162-8666
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Homepage URL
Email ohki.takeshi@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University Hospital
Institute
Department

Funding Source
Organization patient's own expenses
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board, Tokyo Women's Medical University
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo
Tel 03-3353-81111
Email krinri.bm@twmu.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
2014 Year 11 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 No longer recruiting
Date of protocol fixation
2014 Year 09 Month 13 Day
Date of IRB
2014 Year 09 Month 11 Day
Anticipated trial start date
2014 Year 11 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 10 Month 14 Day
Last modified on
2019 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017950

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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