UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015436
Receipt number 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 2021/10/29 09:16:47

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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

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

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 or person

Institute

Tokyo Women's Medical University Hospital

Institute

Department

Personal name



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

21

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

Completed

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

2021 Year 10 Month 29 Day



Link to view the page

Value
https://center6.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