Clinical trial NCT05574517: Tubeless Percutaneous Nephrolithotomy Without Reverse Insertion of a Ureteral Catheter
Official title: A Comparative Study of Tubeless Percutaneous Nephrolithotomy With or Without Reverse Ureteral Catheter Insertion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Calculi
Percutaneous Nephrolithotomy
Keywords: Ureteral catheter
Without reverse insertion
Percutaneous nephrolithotomy
Tubeless
Urinary calculi
Lead sponsor: The First Affiliated Hospital of University of South China
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to an experimental or control group in parallel.
Primary purpose: TREATMENT

Brief summary: Percutaneous nephrolithotomy(PCNL) is a surgical method for upper urinary calculi. The advent of tubeless PCNL (without indwelling nephrostomy tube) has been proved to be safe and effective in reducing postoperative discomfort, shortening hospitalization time and reducing hospitalization costs. Traditional tubeless PCNL usually involves retrograde insertion of the ureteral catheter, which may cause many ureteral related surgical complications. However, there are few reports on tubeless PCNL without reverse ureteral catheter insertion. The goal of this study is to explore the safety and effectiveness of the tubeless PCNL without reverse ureteral catheter insertion.

Detailed description: This is a key clinical research project of the University of South China (No. USCKF201902K01). The goal of this study is to comparative the safety and clinical efficacy between the tubeless percutaneous nephrolithotomy without reverse insertion of a ureteral catheter and the traditional tubeless percutaneous nephrolithotomy with reverse insertion of a ureteral catheter in the treatment of upper urinary calculi, and to explore the former' applications. 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 and the application of computerized random-number generation. For random allocation, participants are given random numbers. Participants with odd numbers are assigned to experimental group, where they undergo tubeless PCNL without reverse insertion of a ureteral catheter. Participants with even numbers are assigned to control group and undergo tubeless PCNL with reverse insertion of a ureteral catheter. 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.

Eligibility criteria: Inclusion Criteria:

* Participants who met the the applications of PCNL surgery in the 2019 Chinese Guidelines for the Diagnosis and Treatment of Urological Diseases
* Participants who agree to undergo tubeless PCNL
* The participants' maximum diameter of the stone should be less than 3.5cm

Exclusion Criteria:

* Confirmation by computerized tomography (CT) images and blood biochemical indicators of infectious stones or complex staghorn stones
* Obvious surgical contraindications, such as severe heart and lung insufficiency, abnormal coagulatory function
* Previous PCNL or nephrolithotomy, presence of an indwelling ureteral stent or nephrostomy tube before surgery
* Renal trauma or congenital malformation of the urinary system

Primary outcomes:
measure: Changes of inflammatory indicators after surgery
timeFrame: Hour 3 after the surgery
measure: Changes in renal bleeding after surgery
timeFrame: Hour 3 after the surgery
measure: Changes of renal-function after surgery
timeFrame: Hour 3 after the surgery
measure: Pain score after surgery
timeFrame: Hour 3 after the surgery
measure: Incidence of pneumothorax and hydrothorax
timeFrame: Day 2 after the surgery
measure: Incidence of ureteral stone street
timeFrame: Day 2 after the surgery
Secondary outcomes:
measure: Duration of operation
timeFrame: during the procedure
measure: Duration of hospital stay
timeFrame: immediately after the discharge
measure: Hospital costs
timeFrame: immediately after the discharge
measure: Stone-free rates
timeFrame: Day 2 after the surgery
Other outcomes:
Locations:
city: Hengyang
country: China
facility: The First Affiliated Hospital of University of South China
state: Hunan
Study officials:
affiliation: The First Affiliated Hospital of University of South China
name: Mingyong Li, MD
role: PRINCIPAL_INVESTIGATOR
References: