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
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
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
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
