UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037055
Receipt number R000042090
Scientific Title Investigation of frequency and risk factors of overpressure for the lower thigh during laparoscopic colorectal surgery
Date of disclosure of the study information 2019/06/18
Last modified on 2019/06/17 15:07:17

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Basic information

Public title

Investigation of frequency and risk factors of overpressure for the lower thigh during laparoscopic colorectal surgery

Acronym

Investigation of frequency and risk factors of overpressure for the lower thigh during laparoscopic colorectal surgery

Scientific Title

Investigation of frequency and risk factors of overpressure for the lower thigh during laparoscopic colorectal surgery

Scientific Title:Acronym

Investigation of frequency and risk factors of overpressure for the lower thigh during laparoscopic colorectal surgery

Region

Japan


Condition

Condition

colorectal disease

Classification by specialty

Surgery in general Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of the efficacy of intraoperative pressure monitoring of the lower thigh during laparoscopic colorectal cancer surgery

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Frequency of intraoperative pressure of lower thigh >50mmHg

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. planed laparoscopic colorectal surgery
2. Age >=20 yo
3. with IC

Key exclusion criteria

1. Restricted mobility of lower thigh
2. Considered as inappropriate for inclusion

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Suguru
Middle name
Last name Hasegawa

Organization

Faculty of Medicine
Fukuoka University

Division name

Dept of Gastroenterological Surgery

Zip code

810-0180

Address

7-45-1 Nanakuma, Johnan, Fukuoka, Japan

TEL

0928011011

Email

shase@fukuoka-u.ac.jp


Public contact

Name of contact person

1st name Suguru
Middle name
Last name Hasegawa

Organization

Faculty of Medicine Fukuoka University

Division name

Dept of Gastroenterological Surgery

Zip code

810-0180

Address

7-45-1 Nanakuma, Johnan, Fukuoka, Japan

TEL

0928011011

Homepage URL


Email

shase@fukuoka-u.ac.jp


Sponsor or person

Institute

Faculty of Medicine Fukuoka University

Institute

Department

Personal name



Funding Source

Organization

Fukuoka University

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

Medical Ethics Committee of Fukuoka University

Address

7-45-1 Nanakuma, Johnan, Fukuoka, Japan

Tel

0928011011

Email

fumed-ethics@fukuoka-u.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

2019 Year 06 Month 18 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

Open public recruiting

Date of protocol fixation

2019 Year 06 Month 17 Day

Date of IRB

2019 Year 06 Month 17 Day

Anticipated trial start date

2019 Year 06 Month 17 Day

Last follow-up date

2022 Year 07 Month 22 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

investigation of factors associated with prognosis or safety of our management for patients with colorectal cancer.


Management information

Registered date

2019 Year 06 Month 13 Day

Last modified on

2019 Year 06 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042090


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name