Clinical trial NCT05661175: Application of One-handed Lithotripsy in Percutaneous Nephrolithotomy
Official title: A Comparative Study of One-handed Lithotripsy and Traditional Lithotripsy in Percutaneous Nephrolithotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Percutaneous Nephrolithotomy
Keywords: Percutaneous nephrolithotomy
one-handed lithotripsy
Urinary calculi
traditional PCNL
Lead sponsor: The First Affiliated Hospital of University of South China
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to an experimental or control group in parallel.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Operative time
timeFrame: during the procedure
measure: Stone clearance rate
timeFrame: Day 2 after the surgery
measure: Renal pelvis mucosal injury rate
timeFrame: during the procedure
measure: Changes in renal bleeding after surgery
timeFrame: Hour 3 after the surgery
Secondary outcomes:
measure: Hospital costs
timeFrame: immediately after the discharge
measure: Hospital stay
timeFrame: immediately after the discharge
Other outcomes:
Locations:
city: Hengyang
country: China
facility: The First Affiliated Hospital of University of South China
state: Hunan
Study officials:
affiliation: The First Affiliated Hospital of University of South China
name: Mingyong Li, MD
role: PRINCIPAL_INVESTIGATOR
References: