Application of One-handed Lithotripsy in Percutaneous Nephrolithotomy

The First Affiliated Hospital of University of South China

Status: Enrolling

Conditions: Percutaneous Nephrolithotomy

Treatments: Procedure: one-handed technique

Study type: Interventional

Funder types: Other

Identifiers

NCT05661175

USCKF202011K20

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Experimental group(group 1)

Experimental group

Description:

Percutaneous nephrolithotripsy was performed using one - hand lithotripsy

Treatment:

Procedure: one-handed technique

Control group(group 2)

No Intervention group

Description:

Percutaneous nephrolithotripsy was performed using traditional techniques