Status:
NOT_YET_RECRUITING
Disposable Versus Disposable Nephroscope During PCNLs: a Feasibility RCT
Lead Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Conditions:
Stone, Kidney
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
A feasibility randomised controlled trials comparing re-usable versus disposable nephroscope when treating kidney stones during mini-PCNLs
Detailed Description
Study Participants Patients undergoing minimally-invasive PCNLs with intention to treat renal low- to medium-burden renal stones. Inclusion Criteria * Patients undergoing mini PCNL to treat renal st...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- • Contraindications to surgical treatment
- 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
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06579924
Start Date
September 1 2024
End Date
April 30 2025
Last Update
August 30 2024
Active Locations (1)
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1
Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510230