UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016863
Receipt number 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 2023/09/25 11:44:42

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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 Itaru
Middle name
Last name IEndo

Organization

Yokohama City University

Division name

Gastroenterological surgery

Zip code

2360004

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 Atsushi
Middle name
Last name Ishibe

Organization

Yokohama City University

Division name

Gastroenterological surgery

Zip code

236-0004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japa

TEL

045-787-2800

Homepage URL


Email

aishibe@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University

Institute

Department

Personal name



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

Yokohama City University

Address

3-9 Fukuura Kanazawa-Ku Yokohama

Tel

045-370-7627

Email

rinri@yokohama-cu.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 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

Completed

Date of protocol fixation

2015 Year 03 Month 04 Day

Date of IRB

2015 Year 04 Month 01 Day

Anticipated trial start date

2015 Year 04 Month 01 Day

Last follow-up date

2025 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

2015 Year 03 Month 21 Day

Last modified on

2023 Year 09 Month 25 Day



Link to view the page

Value
https://center6.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