Application of One-handed Lithotripsy in Percutaneous Nephrolithotomy

Sponsor

The First Affiliated Hospital of University of South China (Other)

Overall Status

Recruiting

CT.gov ID

NCT05661175

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Percutaneous Nephrolithotomy	Procedure: one-handed technique	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants are randomly assigned to an experimental or control group in parallel.Participants are randomly assigned to an experimental or control group in parallel.

Masking:

Single (Participant)

Masking Description:

A single-blind trial in which participants were unaware of the study group and the intervention.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 3, 2022

Anticipated Primary Completion Date :

Nov 3, 2023

Anticipated Study Completion Date :

Nov 3, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Operative time [during the procedure]
From the completion of anesthesia to the end of the suture incision.
Stone clearance rate [Day 2 after the surgery]
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%)
Renal pelvis mucosal injury rate [during the procedure]
Number of accidental injuries of renal pelvis mucosa during operation
Changes in renal bleeding after surgery [Hour 3 after the surgery]
Pre- vs. post-operative difference in hemoglobin and hematocrit values

Secondary Outcome Measures

Hospital costs [immediately after the discharge]
The cost from hospitalization to discharge.
Hospital stay [immediately after the discharge]
The number of days from hospitalization to discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of University of South China	Hengyang	Hunan	China	42100

Sponsors and Collaborators

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 Documents (Full-Text)

Study Protocol - Dec 8, 2022

More Information

Publications

None provided.

Responsible Party:

Li Mingyong, MD, Associate professor, The First Affiliated Hospital of University of South China

ClinicalTrials.gov Identifier:

NCT05661175

Other Study ID Numbers:

USCKF202011K20

First Posted:

Dec 22, 2022

Last Update Posted:

Jan 31, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Li Mingyong, MD, Associate professor, The First Affiliated Hospital of University of South China

Percutaneous nephrolithotomy

one-handed lithotripsy

Urinary calculi

traditional PCNL

Study Results

No Results Posted as of Jan 31, 2023