Tokyo, Aug. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062574) titled 'A Study Examining How the Zero Gravity Position Affects Robot Assisted Surgery in Urology' on Aug. 31.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Active
Primary Sponsor:
Institute - Hiroshima University
Condition:
Condition - Renal cell carcinoma, Renal pelvic carcinoma, Ureteral carcinoma, Adrenal tumor
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
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 Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 08 Month 13 Day
Anticipated trial start date - 2026 Year 09 Month 01 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071624
Disclaimer: Curated by HT Syndication.