The Feasibility, Safety, and Efficacy of Not Indwelling of Ureteral Stents in Percutaneous Nephrolithotomy

Urolithiasis Clinical Trial

Official title:

The Feasibility, Safety, and Efficacy of Not Indwelling of Ureteral Stents in Percutaneous Nephrolithotomy: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06455618
• Other study ID #: MRER(42)2023
• Status: Completed
• Phase: N/A
• Start date: April 2, 2023
• Est. completion date: June 6, 2024

Study information

• Verified date: June 2024
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 6, 2024
• Est. primary completion date: May 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Urolithiasis

Intervention

Procedure:
• not Indwelling the ureteral stent
Before the end of surgery, the urologist does not Indwell the ureteral stent in the patient's body. The ureteral stent is usually called "Double-J Stent".
• Indwelling the ureteral stent
Before the end of surgery, the urologist Indwell the ureteral stent in the patient's body. The ureteral stent is usually called "Double-J Stent".

Locations

Country	Name	City	State
China	Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	Surgery duration, minutes	During surgery
Primary	Hospital stay	Duration of hospital stay after surgery, days	1 week
Primary	Complication rate	Complication is defined as any adverse event occurred intraoperatively or =1 month postoperatively, including intraoperative bleeding, postoperative pain and so on.The investigator will invaluate perioperative complications by modified Clavien system	1 month after sugery
Primary	Visual Analogue Scale(VAS)	The basic method is to use a moving ruler about 10cm long, with 10 scales on one side and "0" and "10" points on both ends, where 0 represents no pain and 10 represents the most unbearable pain.	1 day after sugery
Primary	Wisconsin Stone Quality of Life questionnaire (WISQOL) Scores	A total of 28 questions were included in 4 aspects (social, disease, vitality, and emotion), and a questionnaire was recorded and filled out on the 3rd, 14th, and 1st day after surgery through telephone inquiry and evaluation.	on the 3rd, 14th, and 1st day after surgery