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

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

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.

Study Overview

• Status: Completed
• Conditions: Urolithiasis
• Intervention / Treatment: Procedure: not Indwelling the ureteral stent; Procedure: Indwelling the ureteral stent

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510230
      • Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: stent-less PCNL; In group 1, a nephrostomy tube is indwelled in the patient's body before the end of PCNL.	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".
Active Comparator: stent PCNL; In group 2, a nephrostomy tube and a ureteral stent are indwelled in the patient's body before the end of PCNL.	Procedure: 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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Surgery duration, minutes	During surgery
Hospital stay	Duration of hospital stay after surgery, days	1 week
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
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
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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2023
• Primary Completion (Actual): May 5, 2024
• Study Completion (Actual): June 6, 2024

Study Registration Dates

• First Submitted: June 7, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 7, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: ureteral stent; nephrostomy tube; PCNL; tubeless; WISQOL questionnaire scores
• Additional Relevant MeSH Terms: Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urolithiasis
• Other Study ID Numbers: MRER(42)2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No