UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006376
Receipt number R000007565
Scientific Title Retrospective study of laparoscopic colorectal surgery for elder patient
Date of disclosure of the study information 2011/09/25
Last modified on 2020/06/04 16:22:23

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Basic information

Public title

Retrospective study of laparoscopic colorectal surgery for elder patient

Acronym

Retrospective study of laparoscopic colorectal surgery for elder patient

Scientific Title

Retrospective study of laparoscopic colorectal surgery for elder patient

Scientific Title:Acronym

Retrospective study of laparoscopic colorectal surgery for elder patient

Region

Japan


Condition

Condition

Colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Assess the safety and efficacy of laparoscopic colorectal cancer surgery for over 80 y.o. patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

morbidity rate
mortality rate

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

80 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients over 80 y.o. and underwent surgery for colorectal cancer

Key exclusion criteria

Patients who are thought to be inapropreate for this study

Target sample size

100


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-cho, Aobaku, Sendai, 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 or person

Institute

Hiroshima University

Institute

Department

Personal name



Funding Source

Organization

None

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

2011 Year 09 Month 25 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

2011 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 05 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

none


Management information

Registered date

2011 Year 09 Month 20 Day

Last modified on

2020 Year 06 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007565


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name