Application of One-handed Lithotripsy in Percutaneous Nephrolithotomy

NCT05661175 | Unknown DMC

• 1 other identifier: USCKF202011K20
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Percutaneous Nephrolithotomy

Keywords

Percutaneous nephrolithotomy; one-handed lithotripsy; Urinary calculi; traditional PCNL

Outcome Measures

Primary Outcomes (4)

• 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

• Changes in renal bleeding after surgery

  Pre- vs. post-operative difference in hemoglobin and hematocrit values

  Hour 3 after the surgery

Secondary Outcomes (2)

• Hospital costs

  immediately after the discharge

• Hospital stay

  immediately after the discharge

Study Arms (2)

Experimental group(group 1)

EXPERIMENTAL

Percutaneous nephrolithotripsy was performed using one - hand lithotripsy

Procedure: one-handed technique

Control group(group 2)

NO INTERVENTION

Percutaneous nephrolithotripsy was performed using traditional techniques

Interventions

one-handed technique 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

Experimental group(group 1)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of University of South China: lead

Study Sites (1)

The First Affiliated Hospital of University of South China

Hengyang, Hunan, 42100, China

RECRUITING

MeSH Terms

Conditions

Urinary Calculi

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Mingyong Li, MD

  The First Affiliated Hospital of University of South China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingyong Li, MD

CONTACT

18175878363; myli1123@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: A single-blind trial in which participants were unaware of the study group and the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

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

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 22, 2022
• Study Start: December 3, 2022
• Primary Completion: November 3, 2023
• Study Completion: November 3, 2023
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Starting 1 year after publication.
• 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.

Locations

CN (1)