UMIN-CTR Clinical Trial

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