Percutaneous Nephrolithotomy
Conditions
Keywords
Percutaneous nephrolithotomy, one-handed lithotripsy, Urinary calculi, traditional PCNL
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.
Interventions
PROCEDUREone-handed technique
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
Sponsors
The First Affiliated Hospital of University of South China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
A single-blind trial in which participants were unaware of the study group and the intervention.
Intervention model description
Participants are randomly assigned to an experimental or control group in parallel.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | during the procedure | From the completion of anesthesia to the end of the suture incision. |
| 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 |
| Changes in renal bleeding after surgery | Hour 3 after the surgery | Pre- vs. post-operative difference in hemoglobin and hematocrit values |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital costs | immediately after the discharge | The cost from hospitalization to discharge. |
| Hospital stay | immediately after the discharge | The number of days from hospitalization to discharge |
Countries
China
Contacts
Primary ContactMingyong Li, MD
Outcome results
None listed