UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032897 |
|---|---|
| Receipt number | R000037512 |
| Scientific Title | Lower Limb Perfusion during Robotic-Assisted Radical Prostatectomy Evaluated by Near-Infrared Spectroscopy: An Observational Prospective Study |
| Date of disclosure of the study information | 2018/06/07 |
| Last modified on | 2018/06/07 07:20:53 |
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Basic information
Public title
Lower Limb Perfusion during Robotic-Assisted Radical Prostatectomy Evaluated by Near-Infrared Spectroscopy: An Observational Prospective Study
Acronym
Lower Limb Perfusion during Robotic-Assisted Radical Prostatectomy
Scientific Title
Lower Limb Perfusion during Robotic-Assisted Radical Prostatectomy Evaluated by Near-Infrared Spectroscopy: An Observational Prospective Study
Scientific Title:Acronym
Lower Limb Perfusion during Robotic-Assisted Radical Prostatectomy
Region
| Japan |
Condition
Condition
Robotic-Assisted Radical Prostatectomy
Classification by specialty
| Urology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the effects of patient positioning in lower limb perfusion patients undergoing robot-assisted laparoscopic radical prostatectomy (RARP) using near-infrared spectroscopy (NIRS).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint is to compare lower limb rSO2 value between time points.
Key secondary outcomes
The secondary outcomes are hemodynamic and respiratory parameters.
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
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
Thirty adult males (American Society of Anaesthesiologists class I and II physical status) scheduled for RARP at the Ehime University Hospital, Shitsukawa, Japan, from September 2013 to May 2014 were consecutively selected.
Key exclusion criteria
Patients with previous episodes of peripheral vascular disease and those who were morbidly obese (body mass index > 35 kg/m2) were excluded from the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Takechi |
Organization
Matsuyama Red Cross Hospital
Division name
Anesthesia
Zip code
Address
bunkyocyou matusyama ehime
TEL
089924111
ntakechi@me.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Takechi |
Organization
Matsuyama Red Cross Hospital
Division name
Anesthesia
Zip code
Address
bunkyocyou matusyama ehime
TEL
089924111
Homepage URL
ntakechi@me.com
Sponsor or person
Institute
Department of Anesthesia and Perioperative Medicine, Ehime University Graduate School of Medicine,
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesia and Perioperative Medicine, Ehime University Graduate School of Medicine,
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
Address
Tel
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
愛媛大学附属病院（愛媛県］
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 07 | 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
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 06 | Month | 01 | Day |
Other
Other related information
In the present study, lower limb perfusion evaluated by NIRS was found to be increased after induction of anaesthesia and maintained during the steep Trendelenburg position in RARP patients with no risk of LLCS.
Management information
Registered date
| 2018 | Year | 06 | Month | 07 | Day |
Last modified on
| 2018 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037512
