Application of One-handed Lithotripsy in Percutaneous Nephrolithotomy

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

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

Study Overview

• Status: Recruiting
• Conditions: Percutaneous Nephrolithotomy
• Intervention / Treatment: Procedure: one-handed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mingyong Li, MD; Phone Number: 18175878363; Email: myli1123@126.com

Study Locations

• China
  • Hunan
    • Hengyang, Hunan, China, 42100
      • Recruiting
      • The First Affiliated Hospital of University of South China
      • Contact: Li Mingyong, MD; Phone Number: 18175878363; Email: myli1123@126.com
      • Principal Investigator: Li Mingyong, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group(group 1); Percutaneous nephrolithotripsy was performed using one - hand lithotripsy	Procedure: 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
No Intervention: Control group(group 2); Percutaneous nephrolithotripsy was performed using traditional techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in renal bleeding after surgery	Pre- vs. post-operative difference in hemoglobin and hematocrit values	Hour 3 after the surgery
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

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of University of South China
• Investigators: Principal Investigator: Mingyong Li, MD, The First Affiliated Hospital of University of South China

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2022
• Primary Completion (Anticipated): November 3, 2023
• Study Completion (Anticipated): November 3, 2023

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 26, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Percutaneous nephrolithotomy; Urinary calculi; one-handed lithotripsy; traditional PCNL
• Other Study ID Numbers: USCKF202011K20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data that underlie results in a publication.
• IPD Sharing Time Frame: Starting 1 year after publication.
• IPD Sharing Access Criteria: When proper editing or review requirements are met, the study data will be available from the study manager after the study is completed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No