UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062574 |
|---|---|
| Receipt number | R000071624 |
| Scientific Title | A Randomized Controlled Trial Evaluating the Impact of the Zero Gravity Position on Robot Assisted Surgery in Urology |
| Date of disclosure of the study information | 2026/08/31 |
| Last modified on | 2026/08/29 08:58:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Study Examining How the Zero Gravity Position Affects Robot Assisted Surgery in Urology
Acronym
The ZERO G Study
Scientific Title
A Randomized Controlled Trial Evaluating the Impact of the Zero Gravity Position on Robot Assisted Surgery in Urology
Scientific Title:Acronym
The ZERO G Trial
Region
| Japan |
Condition
Condition
Renal cell carcinoma, Renal pelvic carcinoma, Ureteral carcinoma, Adrenal tumor
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In robot-assisted surgery which is performed in the lateral decubitus position, we will compare our newly developed Zero-Gravity position with the conventional position to evaluate their respective advantages and disadvantages.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain in the shoulder joint and both upper limbs, as well as the degree of peripheral neuropathy, will be assessed using questionnaires at 24 and 48 hours postoperatively. Postoperative pain will be evaluated using the Visual Analog Scale (VAS), and peripheral neuropathy will be assessed using the Numerical Rating Scale (NRS). In this study, postoperative 24 hours is defined as the period from 22 to 26 hours after the end of surgery, and postoperative 48 hours is defined as the period from 46 to 50 hours after the end of surgery.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
In the intervention group (Zero-Gravity position group), the upper limbs will be repositioned as follows: the non-operative arm will be extended caudally and placed alongside the abdomen, while the operative arm will remain extended caudally but will be secured using an additional support so that it is positioned dorsally relative to the lumbar region.
Interventions/Control_2
In the control group (conventional position group), both upper arms will be fixed anterior to the face as in the standard surgical position.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants undergoing robot-assisted partial nephrectomy, robot-assisted radical nephrectomy, robot-assisted nephroureterectomy, or robot-assisted adrenalectomy
Participants aged 18 years or older at the time of obtaining informed consent
Participants who are able to provide written informed consent for participation in this study
Key exclusion criteria
Patients who are unable to speak Japanese
Patients with impaired cognitive function
Patients with renal cell carcinoma classified as clinical T stage cT3b or higher
Patients with significant preoperative restriction of shoulder joint range of motion or upper-limb pain
Patients deemed inappropriate for inclusion by the principal investigator or co-investigatorsv
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Hinata |
Organization
Hiroshima University Hospital
Division name
Department of Urology
Zip code
7348551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima Prefecture, Japan
TEL
0822575242
uro-ikyoku@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryoken |
| Middle name | |
| Last name | Yamanaka |
Organization
Hiroshima University Hospital
Division name
Department of Urology
Zip code
734-0005
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima Prefecture, Japan
TEL
0822575242
Homepage URL
uro2626@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Ryoken Yamanaka
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University Hospital, Department of Urology
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima Prefecture, Japan
Tel
0822575242
uro-ikyoku@hiroshima-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
| 2026 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 13 | Day |
Last modified on
| 2026 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071624
