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

NCT ID: NCT06455618

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-02
• Study Completion Date: 2024-06-06

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.

Conditions

Urolithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

stent-less PCNL

In group 1, a nephrostomy tube is indwelled in the patient's body before the end of PCNL.

Group Type: EXPERIMENTAL

not Indwelling the ureteral stent

Intervention Type: PROCEDURE

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".

stent PCNL

In group 2, a nephrostomy tube and a ureteral stent are indwelled in the patient's body before the end of PCNL.

Group Type: ACTIVE_COMPARATOR

Indwelling the ureteral stent

Intervention Type: PROCEDURE

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".

Interventions

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".

Intervention Type: 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".

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Guohua Zeng

Vice president

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

MRER(42)2023

Identifier Type: -

Identifier Source: org_study_id