Disposable Versus Disposable Nephroscope During PCNLs: a Feasibility RCT
Re-usable Versus Disposable Rigid Nephroscope During Mini-PCNLs When Treating Large-burden Kidney Stones: an Feasibility Randomised Controlled Trial
1 other identifier
interventional
100
1 country
1
Brief Summary
A feasibility randomised controlled trials comparing re-usable versus disposable nephroscope when treating kidney stones during mini-PCNLs
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2024
CompletedFirst Posted
Study publicly available on registry
August 30, 2024
CompletedStudy Start
First participant enrolled
September 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedAugust 30, 2024
August 1, 2024
7 months
August 11, 2024
August 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Stone free rate
ability of used scope in determining a complete stone clearance, or absence of clinically significant residual fragments
90 days post-op
Secondary Outcomes (2)
complication rate
30 days post-op
adequacy of used instrument
intra-operative assessment
Study Arms (2)
Mini-PCNL with disposable scope
EXPERIMENTALPCNLs carried out using disposable scope
Mini-PCNL using re-usable scope
ACTIVE COMPARATORMini-PCNLs carried out using re-usable scope
Interventions
Mini-PCNL carried out using disposable scope
Mini-PCNL carried out using re-usable scope
Eligibility Criteria
You may qualify if:
- Patients undergoing mini PCNL to treat renal stones with a cumulative stone diameter 2-5 cm and completing at least a 3 month's follow-up
- Cases performed by surgeons beyond their learning curves
- Patients aged \> 18
- Unenhanced CT scan carried out within 3 months pre-operatively
- Post-operative follow-up carried out according to our study protocol, with NCCT carried out within 2-3 months after surgery
- ASA 1-2
- Patients with normal weight (BMI: 18-25)
- Participant is willing and able to give informed consent to the proposed surgical treatment and agreeing to be enrolled in the study.
You may not qualify if:
- PCNL performed for proximal ureteric stones
- Urinary tract with abnormal anatomy
- Obese patients
- ASA\>3
- Patients with pyonephrosis
- Patients on anticoaugulants
- Preoperative CT scan not within 3 months before surgery
- Pregnant patients
- Patients younger than 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510230, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 11, 2024
First Posted
August 30, 2024
Study Start
September 1, 2024
Primary Completion
March 30, 2025
Study Completion
April 30, 2025
Last Updated
August 30, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share