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 | 2024/08/25 12:31:27 |
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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
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
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
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
Completed
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 | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024329
