UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021089
Receipt number R000024329
Scientific Title Effect of steep trendelenburg positioning on cerebral blood volume, intraocular pressure and visual function during robotic-assisted radical prostatectomy
Date of disclosure of the study information 2016/02/19
Last modified on 2024/02/24 09:24:29

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Basic information

Public title

Effect of steep trendelenburg positioning on cerebral blood volume, intraocular pressure and visual function during robotic-assisted radical prostatectomy

Acronym

Robotic-assisted surgery and cerebral blood volume and visual function

Scientific Title

Effect of steep trendelenburg positioning on cerebral blood volume, intraocular pressure and visual function during robotic-assisted radical prostatectomy

Scientific Title:Acronym

Robotic-assisted surgery and cerebral blood volume and visual function

Region

Japan


Condition

Condition

prostate cancer

Classification by specialty

Ophthalmology Urology Anesthesiology
Operative medicine Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Assessment of cerebral blood flow and visual function under robotic-assisted surgery

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change of hemoglobin in head by near infra-red spectroscopy, intraocular pressure, visual function

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

50 years-old <=

Age-upper limit

80 years-old >=

Gender

Male

Key inclusion criteria

Male patient who is scheduled for robotic-assisted prostatectomy

Key exclusion criteria

Patient who has eye disease and judged as inappropriate for robotic-assisted prostatectomy

Target sample size

240


Research contact person

Name of lead principal investigator

1st name Nobuko
Middle name
Last name Ito

Organization

The University of Tokyo Hospital

Division name

Department of Anesthesiology

Zip code

1138655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Email

nobuko-tky@umin.ac.jp


Public contact

Name of contact person

1st name Nobuko
Middle name
Last name Ito

Organization

The University of Tokyo Hospital

Division name

Department of Anesthesiology

Zip code

1138655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Homepage URL


Email

nobuko-tky@umin.ac.jp


Sponsor or person

Institute

The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

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

Ethics Committee, Faculty of Medicine, University of Tokyo

Address

7-3-1, Hongo Bunkyo-ku, Tokyo

Tel

03-3815-5411

Email

ethics@m.u-tokyo.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

東京大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2016 Year 02 Month 19 Day


Related information

URL releasing protocol

https://doi.org/10.1111/iju.14183

Publication of results

Unpublished


Result

URL related to results and publications

https://doi.org/10.1111/iju.14183

Number of participants that the trial has enrolled

110

Results

37 were diagnosed with ocular diseases before surgery. IOP significantly increased during surgery. Transient postoperative visual field defect was detected in 24 eyes at 7 days. At 3 months , two eyes continued to show visual field defect, although remaining patients recovered to preoperative conditions.Robot-assisted laparoscopic prostatectomy can be safely carried out in patients with ocular diseases, even those with glaucoma, after precautionary consultation with an ophthalmologist.

Results date posted

2023 Year 08 Month 25 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2020 Year 02 Month 11 Day

Baseline Characteristics

Men aged 50 to 80 who underwent robot-assisted prostatectomy for localized prostate cancer from December 2015 to March 2017 at the University of Tokyo Hospital. Patients with severe pulmonary hypertension, cardiac insufficiency, and a history of either cerebral infarction and/or hemorrhage, or rectal operation were excluded from our study. Patients with ocular disease who were judged inappropriate by an ophthalmologist were excluded.

Participant flow

Written informed consent was obtained from each patient before RALP. We included patients with pre-existing eye diseases, such as previous eye trauma, cataract and glaucoma. All patients completed preoperative consultation with ophthalmologists; their cases were fully reviewed before surgery by urologists and anesthesiologists, together with the consulting ophthalmologists.
RALP using the da Vinci Surgical System was carried out for localized prostate cancer with an angle of 25 degree under TP by multiple experienced surgeons. The pneumoperitoneum during the entire procedure was induced with CO2 insufflation. After induction of general anesthesia, intraocular pressure and vital signs were measured at predetermined time points. In the outpatient clinic before and after RALP, visual field testing and intra was carried out. In cases in which visual field abnormalities were observed in ophthalmologic examinations up to 7 days after surgery, additional ophthalmologic examinations were performed 3 months later.

Adverse events

No adverse events

Outcome measures

Ophthalmic examination: visual field test and intraocular pressure before and after robot-assisted prostatectomy
During surgery: intraocular pressure, blood pressure, HR, changes in cerebral blood flow, blood data, volume of transfusion, volume of bleeding, method of anesthesia
Medical Record: comorbidities, oral medications, blood data before and after surgery (blood count, electrolytes, creatinine), image test data

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2015 Year 10 Month 13 Day

Date of IRB

2015 Year 10 Month 01 Day

Anticipated trial start date

2015 Year 12 Month 01 Day

Last follow-up date

2019 Year 12 Month 01 Day

Date of closure to data entry

2023 Year 01 Month 01 Day

Date trial data considered complete

2023 Year 01 Month 01 Day

Date analysis concluded

2023 Year 01 Month 01 Day


Other

Other related information

Change of hemoglobin in head by near infra-red spectroscopy, intraocular pressure, visual function


Management information

Registered date

2016 Year 02 Month 18 Day

Last modified on

2024 Year 02 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024329


Research Plan
Registered date File name

Research case data specifications
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Research case data
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