A Multicenter, Randomized Controlled Trial Comparing the Retrograde Intrarenal Surgery With a Tip-Flexible Suction Access Sheath to the Standard Percutaneous Nephrolithotomy for the Treatment of 2-3 cm Unilateral Renal Stones
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a multicenter, randomized controlled trial comparing retrograde intrarenal surgery (RIRS) using a tip-flexible suction access sheath with standard percutaneous nephrolithotomy (PCNL) for the treatment of 2-3 cm unilateral renal stones. The aim is to evaluate the clinical efficacy and safety of the novel suction sheath-assisted RIRS compared to standard PCNL in terms of stone-free rate and postoperative complications. A total of 308 patients will be enrolled across four centers in China.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Age between 18 and 80 years
• American Society of Anesthesiologists (ASA) physical status classification of I-III
• Single renal stone with a diameter between 2-3 cm confirmed by non-contrast CT scan
• Signed written informed consent and willingness to comply with study procedures
Locations
Other Locations
China
Changhai Hospital, Naval Medical University
RECRUITING
Shanghai
Contact Information
Primary
Xiaofeng Gao
gxfdoc@sina.com
+86-21-13601600968
Time Frame
Start Date:2025-04-01
Estimated Completion Date:2026-06-30
Participants
Target number of participants:308
Treatments
Experimental: Retrograde Intrarenal Surgery (RIRS) with Tip-Flexible Suction Access Sheath
Participants in this group will undergo retrograde intrarenal surgery (RIRS) using a tip-flexible suction access sheath for the treatment of 2-3 cm unilateral renal stones.
Experimental: Standard Percutaneous Nephrolithotomy (PCNL)
Participants in this group will undergo standard percutaneous nephrolithotomy (PCNL) for the treatment of 2-3 cm unilateral renal stones.
Collaborators: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Affiliated Hospital of Jiaxing University, Zhejiang Provincial People's Hospital