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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032897
Receipt No. R000037512
Official scientific title of the study 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

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Basic information
Official scientific title of the study Lower Limb Perfusion during Robotic-Assisted Radical Prostatectomy Evaluated by Near-Infrared Spectroscopy: An Observational Prospective Study
Title of the study (Brief title) 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 Kenichi Takechi
Organization Matsuyama Red Cross Hospital
Division name Anesthesia
Address bunkyocyou matusyama ehime
TEL 089924111
Email ntakechi@me.com

Public contact
Name of contact person Kenichi Takechi
Organization Matsuyama Red Cross Hospital
Division name Anesthesia
Address bunkyocyou matusyama ehime
TEL 089924111
Homepage URL
Email ntakechi@me.com

Sponsor
Institute Department of Anesthesia and Perioperative Medicine, Ehime University Graduate School of Medicine,
Institute
Department

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037512

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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