Application of One-handed Lithotripsy in Percutaneous Nephrolithotomy
- Conditions
- Percutaneous Nephrolithotomy
- Interventions
- Procedure: one-handed technique
- Registration Number
- NCT05661175
- Lead Sponsor
- The First Affiliated Hospital of University of South China
- Brief Summary
Percutaneous nephrolithotomy(PCNL) is a surgical method for upper urinary calculi.Traditional percutaneous nephrolithotomy usually requires the lithotripsy with the left hand holding the nephroscope and the right hand adjusting the laser fiber,which requires a lot of practice to master this technique.The goal of this study is to explore the safety and effectiveness of the PCNL with one-handed lithotripsy technique
- Detailed Description
This is a key clinical research project of the University of South China(NO.USCKF201902K01).The goal of this study is to compare the safety,effectiveness and feasibility between the percutaneous nephrolithotomy with one-handed technique and the traditional percutaneous nephrolithotomy in the treatment of upper urinary calculi. It is a prospective, randomized controlled single center study that is conducted for 2 years anticipatively. The clinic physician is responsible for patient recruitment and allocation.For random allocation,participants are randomly grouped by coin toss method.Participants with front side are assigned to experimental group,where they undergo PCNL with one-handed lithotripsy.Participants with reverse side are assigned to control group and undergo traditional PCNL.The doctors managing the operations accept participants and execute the surgical treatments.All participants sign clinical-trial informed consent and surgical informed consent during the preoperative conversation.Follow-up observation is conducted for 1 month after surgery. After completion of the study, we collect relevant clinical data from the participants. The primary and secondary outcomes are analyzed and compared between the two groups.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Participants who met the the applications of PCNL surgery in the 2019 Chinese Guidelines for the Diagnosis and Treatment of Urological Disease.
- Participants who agree to undergo one-hand lithotripsy.
- Obvious surgical contraindications, such as severe heart and lung insufficiency, abnormal coagulatory function.
- Confirmation by computerized tomography (CT) images and blood biochemical indicators of infectious stones or complex staghorn stones
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group(group 1) one-handed technique Percutaneous nephrolithotripsy was performed using one - hand lithotripsy
- Primary Outcome Measures
Name Time Method Stone clearance rate Day 2 after the surgery Preoperative and postoperative stone dimensions are compared by radiological assessment. Postoperative residual calculi \< 4 mm in diameter reflect complete removal of calculi (stone-free rate = 100%)
Renal pelvis mucosal injury rate during the procedure Number of accidental injuries of renal pelvis mucosa during operation
Operative time during the procedure From the completion of anesthesia to the end of the suture incision.
Changes in renal bleeding after surgery Hour 3 after the surgery Pre- vs. post-operative difference in hemoglobin and hematocrit values
- Secondary Outcome Measures
Name Time Method Hospital stay immediately after the discharge The number of days from hospitalization to discharge
Hospital costs immediately after the discharge The cost from hospitalization to discharge.
Trial Locations
- Locations (1)
The First Affiliated Hospital of University of South China
🇨🇳Hengyang, Hunan, China