Application of One-handed Lithotripsy in Percutaneous Nephrolithotomy

Percutaneous Nephrolithotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05661175
• Other study ID #: USCKF202011K20
• Status: Recruiting
• Phase: N/A
• Start date: December 3, 2022
• Est. completion date: November 3, 2023

Study information

• Verified date: March 2023
• Source: The First Affiliated Hospital of University of South China
• Contact: Mingyong Li, MD
• Phone: 18175878363
• Email: myli1123[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 3, 2023
• Est. primary completion date: November 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Percutaneous Nephrolithotomy

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of University of South China	Hengyang	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of University of South China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	From the completion of anesthesia to the end of the suture incision.	during the procedure
Primary	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
Primary	Renal pelvis mucosal injury rate	Number of accidental injuries of renal pelvis mucosa during operation	during the procedure
Primary	Changes in renal bleeding after surgery	Pre- vs. post-operative difference in hemoglobin and hematocrit values	Hour 3 after the surgery
Secondary	Hospital costs	The cost from hospitalization to discharge.	immediately after the discharge
Secondary	Hospital stay	The number of days from hospitalization to discharge	immediately after the discharge