Application of One-handed Lithotripsy in Percutaneous Nephrolithotomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Comparative Study of One-handed Lithotripsy and Traditional Lithotripsy in Percutaneous Nephrolithotomy

Conditions
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Percutaneous Nephrolithotomy

Intervention / Treatment
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* Procedure: one-handed technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomly assigned to an experimental or control group in parallel.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group(group 1)<br>Percutaneous nephrolithotripsy was performed using one - hand lithotripsy | Procedure: one-handed technique<br>* Traditional percutaneous nephrolithotripsy usually requires the left hand to hold the nephroscope and the right hand to control the fiber for lithotripsy.Our intervention is to control the depth and direction of the sheath with the left hand, the nephroscope in the right hand and control the fiber optic lithotripsy<br>|
| No Intervention: Control group(group 2)<br>Percutaneous nephrolithotripsy was performed using traditional techniques | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | From the completion of anesthesia to the end of the suture incision. | during the procedure | 
| Stone clearance rate | 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%) | Day 2 after the surgery | 
| Renal pelvis mucosal injury rate | Number of accidental injuries of renal pelvis mucosa during operation | during the procedure | 
| Changes in renal bleeding after surgery | Pre- vs. post-operative difference in hemoglobin and hematocrit values | Hour 3 after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital costs | The cost from hospitalization to discharge. | immediately after the discharge | 
| Hospital stay | The number of days from hospitalization to discharge | immediately after the discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous nephrolithotomy, one-handed lithotripsy, Urinary calculi, traditional PCNL