UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052881 |
|---|---|
| Receipt number | R000060161 |
| Scientific Title | Intraoperative intraocular pressure changes in robot-assisted laparoscopic total prostatectomy |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2023/11/22 13:40:46 |
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Basic information
Public title
Intraoperative intraocular pressure changes in robot-assisted laparoscopic total prostatectomy
Acronym
Intraoperative intraocular pressure changes in robot-assisted laparoscopic total prostatectomy
Scientific Title
Intraoperative intraocular pressure changes in robot-assisted laparoscopic total prostatectomy
Scientific Title:Acronym
Intraoperative intraocular pressure changes in robot-assisted laparoscopic total prostatectomy
Region
| Japan |
Condition
Condition
prostate cancer scheduled to have Robotic-assisted laparoscopic total prostatectomy
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
There are reports of visual impairment after da Vinci surgery. The main cause of visual failuare is suspected that increased intraocular pressure (IOP) due to prolonged head down position.
In this study, we performed preoperative ophthalmologic examination (visual acuity, intraocular pressure, corner angle widening, etc.). In operative day, patients with no abnormalities at preoperative ophthalmologic examination were estimated IOP during surgery, and post operative day.
To determine the effect of low head position and pneumoperitoneum pressure on IOP. Also, find out what risk factors increasing IOP.
These investigations will determine the safety of da Vinci surgery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Preoperative ophthalmologic examination (performed by an ophthalmologist in an ophthalmology outpatient clinic): measurement of intraocular pressure with Tonopen(Non-contact tonometer).
Ophthalmologist examine for abnormalities in IOP, corner angles, fundus findings.
Key secondary outcomes
a) 1 Visual acuity test (corrected visual acuity) 2 Slit-lamp microscopy (presence of cataracts, corner angle widening, anterior chamber depth, pupil diameter) 3 Fundus examination.
b) 1 Anaesthetic method, amount of phenirephrine and ephedrine, and atropine 2Operative technique, time of head down position, insufflation time, operative time, amount of blood loss and infusion volume
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
usually, we do not estimate IOP during da vinch surgery unlike this study because keratitis is rarely caused by using Tonopen.
As a precaution, antibiotic eye drops were used before measurements and the cover on the tip of the tonopen was changed at each measurement.
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
| 30 | years-old | < |
Age-upper limit
| 83 | years-old | >= |
Gender
Male
Key inclusion criteria
Adult men with ASA I or II undergoing da Vinci surgery and have given consent for the study.
Key exclusion criteria
Patients with corneal disease, glaucoma, diabetic retinopathy (Fukuda classification A1 or higher) and other conditions deemed inappropriate at the preoperative consultation.
Patients with systemic complications above ASA III
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takenami |
| Middle name | |
| Last name | Tamie |
Organization
Kitasato University School of Medicine
Division name
Anesthesiology
Zip code
252 0375
Address
Kitasato University School of Medicine, 1-15-1 Kitasato, Sagamihara city, Minamiku, Kanagawa, Japan
TEL
040-778-8111
takenami@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Takenami |
| Middle name | |
| Last name | Tamie |
Organization
Kitasato University School of Medicine
Division name
Anesthesiology
Zip code
252 0375
Address
Kitasato University School of Medicine, 1-15-1 Kitasato, Sagamihara city, Minamiku, Kanagawa, Japan
TEL
040-778-8111
Homepage URL
takenami@med.kitasato-u.ac.jp
Sponsor or person
Institute
Takenami Tamie
Kitasato University School of Medicine, 1-15-1 Kitasato, Sagamihara city, Minamiku, Kanagawa, Japan
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
none
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 Revyew Office, Kitasato University School of Medicine
Address
Kitasato University School of Medicine, 1-15-1 Kitasato, Sagamihara city, Minamiku, Kanagawa, Japan
Tel
042 778 8111
rinnrib@med.kitasato-u.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
This stusy is not available to the public
Publication of results
Unpublished
Result
URL related to results and publications
This stusy is not available to the public
Number of participants that the trial has enrolled
35
Results
LARP is performed by a transperitoneal approach(I; head-down angle 25) and a retroperitoneal approach(R; head-down angle 5).
*l approach has significantly less effect on IOP.
*The influence of pneumoperitoneum pressure on IOP is not greater than that of head down position.
*We investigated risk factors for increased IOP.
As a results, the younger the age, and the heavier the weight are the risk factor for increasing the intraocular pressure only in the I approach group
Results date posted
| 2023 | Year | 11 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Takenami, who was in charge of the research, suffered cerebral infarctions in December 2015 and 2018 and underwent STA-MCA bypass surgery, resulting in a long research period.
Date of the first journal publication of results
Baseline Characteristics
Recently, visual impairment after prone surgery has been reported. The cause is suspected to be increased intraocular pressure.
Similar reports have been made regarding da Vinci surgery, and increased intraocular pressure due to a low head position is suspected to be the cause.
However, there are few reports on measuring intraocular pressure during da Vinci surgery.
Therefore, we measured intraocular pressure in two kind of da Vinci surgeries (25 degree of transperitoneal approach vs. 15degree of retroperitoneal approach) with different head-lowing angles.
Participant flow
Patients scheduled for da Vinci surgery on Wednesday will be admitted to the hospital on Tuesday.
After the patient is admitted around 10 a.m. on Tuesday, Dr. Takenami conduct a preoperative consultation to obtain consent for the study from adult patients with ASAI or II.
If consent is obtained from patient, we contact the ophthalmology outpatient clinic and have them receive the ophthalmology outpatient clinic.
The presence or absence of any problems during the ophthalmology visit will be checked using medical records, and for patients with no ophthalmological problems, intraocular pressure will be measured during surgery on the following Wednesday.
Adverse events
nothing
Outcome measures
*Preoperative ophthalmological examination
Visual acuity, angle, intraocular pressure, fundus examination.
*Intraoperative examination
Intraocular pressure measurement is performed with a Tonopen. we are sure to apply antibiotic eye drops before and after measuring intraocular pressure.
Measurement points: At the start of surgery, at the start of pneumoperitoneum, after the start of head low position, 1 hour after the start of head low position, 2 hours after the start, at the time of ureter resection, just before the end of low head position
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 16 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 13 | Day |
Date analysis concluded
| 2020 | Year | 02 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 23 | Day |
Last modified on
| 2023 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060161
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