Total Tubeless Percutaneous Nephrolithotomy Without a Ureteral Catheter

Status Recruiting

Clinical Trial Summary

Total tubeless Percutaneous nephrolithotomy (PCNL) is a modified surgical method of PCNL surgery, that is, there is no indwelling nephrostomy tube and double-J tube during PCNL surgery. Compared with traditional PCNL surgery, it has the advantages of reducing pain, shortening operation time and reducing operation cost. Since this procedure was first performed in 2004, several randomized clinical studies have verified the safety and efficacy of total tubeless PCNL. Conventional total tubeless PCNL surgery requires the patient to first undergo retrograde transurethral ureteroscopic insertion of the ureteral catheter in the lithotomy position, and then change the patient to the prone position. However, a large number of literature reports and the surgical experience of PCNL in the past 20 years tell the investigators that the reverse insertion of ureteral catheter can cause many recent surgical complications.The study planned to perform the operation in the prone position without reverse insertion of a ureteral catheter in the total tubular PCNL surgery.

Clinical Trial Description

The purpose of this single-center, single-blind, randomized trial was to investigate whether without retrograde insertion of a ureteral catheter is appropriate for total tubeless percutaneous nephrolithotomy. It is planned to start in October 2022 and is expected to end in October 2024. Based on inclusion and exclusion criteria, 100 subjects were expected to be recruited. In a parallel group design, subjects were randomly assigned to two groups: the experimental group received total tubeless PCNL without reverse insertion of a ureteral catheter , and the control group received conventional total tubeless PCNL. The primary end point of the study was the incidence of postoperative complications according to the modified Clavien-Dindo complication grading system. Secondary end points included Stone-free rate, operation time, length of hospital stay, and medical costs. Measurement data were expressed as mean ± standard deviation (X ± S), and Student's t-test was used for intergroup comparisons. The counting data were expressed as frequency and percentage, and the chi-squared or Fisher's exact probability test were used for intergroup comparisons. The rank-sum test was used for grade data. P<0.05 was considered statistically significant. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05578807
Study type	Interventional
Source	The First Affiliated Hospital of University of South China
Contact	Mingyong Li, MD.
Phone	137-8648-4606
Email	myli1123@126.com
Status	Recruiting
Phase	N/A
Start date	September 28, 2022
Completion date	January 10, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05100017` - Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure	N/A
Recruiting	`NCT04559321` - Holmium Vs Trilogy Kidney Stones GUY's 1-2	Phase 3
Completed	`NCT04332861` - Evaluation of Infection in Obstructing Urolithiasis
Completed	`NCT03018899` - Paravertebral Block Versus Epidural Anesthesia for Percutaneous Nephrolithotomy	N/A
Recruiting	`NCT02489656` - Quality of Life in Patients With Double Loop Ureteral Stent (JJ Silicone Hydrogel Study)	Phase 4
Completed	`NCT00177086` - Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi	Phase 3
Completed	`NCT03957109` - Influence of Anesthesia Methods on Surgical Outcomes and Renal Function	N/A
Active, not recruiting	`NCT05082142` - Tranexamic Acid to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP)	Phase 4
Completed	`NCT05911945` - Failed Insertion of Ureteral Access Sheath During Flexible Ureterorenoscopy	N/A
Recruiting	`NCT03599297` - Bilateral Synchronous Simultaneous Stone Surgery	N/A
Recruiting	`NCT05701098` - SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)	N/A
Completed	`NCT03888144` - Study of Ketorolac Versus Opioid for Pain After Endoscopy	Phase 4
Withdrawn	`NCT04545528` - The Impact of Nutritional Service in the Stone Clinic on the Patient Urine Collection Results
Recruiting	`NCT05598671` - Percutaneous Nephrolithotomy Without a Ureteral Catheter	N/A
Completed	`NCT05511545` - The Effect of Education Given to Patients on Pre- and Post-operative Anxiety and Preparation for Discharge	N/A
Not yet recruiting	`NCT04606758` - Fluoroscopic Guided vs US-guided Percutaneous Nephrolithotripsy for the Treatment of Stone Disease	N/A
Recruiting	`NCT03855787` - Ureteral Stent Placement After Ureteroscopy for Renal Stones: A Randomized Controlled Trial	N/A
Completed	`NCT04069338` - Comparison of Lithotripsy Urolithiasis Machines	N/A
Completed	`NCT01329042` - Efficacy of Potassium Sodium Hydrogen Citrate Therapy on Renal Stone Recurrence and/or Residual Fragments After Shockwave Lithotripsy and Percutaneous Nephrolithotomy in Calcium Oxalate Urolithiasis	Phase 4
Recruiting	`NCT06330246` - O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease	N/A