Application of One-handed Lithotripsy in Percutaneous Nephrolithotomy

NCT ID: NCT05661175

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-03
• Study Completion Date: 2023-11-03

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.

Conditions

Percutaneous Nephrolithotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group(group 1)

Percutaneous nephrolithotripsy was performed using one - hand lithotripsy

Group Type: EXPERIMENTAL

one-handed technique

Intervention Type: PROCEDURE

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

Control group(group 2)

Percutaneous nephrolithotripsy was performed using traditional techniques

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

one-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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of University of South China

OTHER

Sponsor Role: lead

Responsible Party

Li Mingyong, MD

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mingyong Li, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of University of South China

Locations

The First Affiliated Hospital of University of South China

Hengyang, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Mingyong Li, MD

Role: CONTACT

myli1123@126.com

18175878363

Facility Contacts

Li Mingyong, MD

Role: primary

myli1123@126.com

18175878363

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

USCKF202011K20

Identifier Type: -

Identifier Source: org_study_id