Clinical trial NCT06455618: The Feasibility, Safety, and Efficacy of Not Indwelling of Ureteral Stents in Percutaneous Nephrolithotomy
Official title: The Feasibility, Safety, and Efficacy of Not Indwelling of Ureteral Stents in Percutaneous Nephrolithotomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urolithiasis
Keywords: PCNL
ureteral stent
nephrostomy tube
tubeless
WISQOL questionnaire scores
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Percutaneous nephrolithotomy (PCNL) is currently the preferred treatment for upper urinary tract stones larger than 2cm. In the standard PCNL procedure, a nephrostomy tube and a ureteral stent are often placed before the end of surgery. Recently, PCNL without indwelling nephrostomy tube but with indwelling ureteral stent (also called "tubeless PCNL") or PCNL without indwelling nephrostomy tube and ureteral stent (also called "totally tubeless PCNL") has been put into practice. Compared with the standard PCNL , tubeless or totally tubeless PCNL can effectively reduce postoperative pain and shorten hospital stay, while the incidence of complications does not significantly increase.

Is it possible not to leave a ureteral stent but leave a nephrostomy tube (also called "stent-less PCNL") after PCNL? In theory, the nephrostomy tube can have certain effect, such as decreasing the risk of post-operative bleeding. On the other hand, not indwelling a ureteral stent can bring benefits to patients. Recently, there is limited research on not indwelling ureteral stent after PCNL, and its safety and feasibility require clinical validation.

In summary, investigators conducted a prospective randomized controlled trial to explore the safety and feasibility of not indwelling ureteral stent after PCNL.

Detailed description: Percutaneous nephrolithotomy (PCNL) is currently the preferred treatment for upper urinary tract stones larger than 2cm. In the standard PCNL procedure, a nephrostomy tube and a ureteral stent are often placed before the end of surgery to ensure urine drainage, promote fistula healing, and reduce the occurrence of kidney stones entering the ureter. With the improvement of surgical techniques, PCNL without indwelling nephrostomy tube but with indwelling ureteral stent (also called "tubeless PCNL") or PCNL without indwelling nephrostomy tube and ureteral stent (also called "totally tubeless PCNL") has been put into practice. Compared with the standard PCNL , tubeless or totally tubeless PCNL can effectively reduce postoperative pain and shorten hospital stay, while the incidence of complications does not significantly increase.

Is it possible not to leave a ureteral stent but leave a nephrostomy tube (also called "stent-less PCNL") after PCNL? This clever method combined two advantages. In theory, the nephrostomy tube can have certain effect, such as decreasing the risk of post-operative bleeding, and avoiding the occurrence of emergency events related to ureteral stones. On the other hand, not indwelling a ureteral stent can bring benefits to patients. Recently, there is limited research on not indwelling ureteral stent after PCNL, and its safety and feasibility require clinical validation.

On the other hand, the Wisconsin Stone Quality of Life (WISQOL), as a specific quality of life scoring system for stone patients, has been widely promoted and applied in many countries around the world. Investigators have recently translated this foreign version of the scoring system into Chinese in order to help serve patients with urinary tract stones in China.

In summary, investigators conducted a single center prospective randomized controlled trial (RCT) to compare and analyze the complications of not indwelling ureteral stent after PCNL, WISQOL questionnaire scores, and explore the safety and feasibility of not indwelling ureteral stent after PCNL.

Eligibility criteria: Inclusion Criteria:

* Age 18-75 years old
* Renal stones\>2cm, preparing for PCNL
* Normal reading comprehension ability

Exclusion Criteria:

* Patients with preoperative neurogenic bladder, Over Active Bladder (OAB), and lower urinary tract symptoms (LUTS).
* Kidney transplantation, isolated kidney, horseshoe kidney, urinary diversion, urinary tract abnormalities.
* Stricture of ureter or stones of the affected ureter require treatment
* Kidney abscess or uncontrolled urinary tract infection
* Internal stent was left in the affected ureter within one year

Primary outcomes:
measure: Operative time
timeFrame: During surgery
measure: Hospital stay
timeFrame: 1 week
measure: Complication rate
timeFrame: 1 month after sugery
measure: Visual Analogue Scale(VAS)
timeFrame: 1 day after sugery
measure: Wisconsin Stone Quality of Life questionnaire (WISQOL) Scores
timeFrame: on the 3rd, 14th, and 1st day after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References: