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

NCT06455618 | Completed DMC

• 1 other identifier: MRER(42)2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Urolithiasis

Keywords

PCNL; ureteral stent; nephrostomy tube; tubeless; WISQOL questionnaire scores

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

stent-less PCNL

EXPERIMENTAL

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

Procedure: not Indwelling the ureteral stent

stent PCNL

ACTIVE COMPARATOR

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

Interventions

not Indwelling the ureteral stent 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-less PCNL

Indwelling the ureteral stent 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".

stent PCNL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510230, China

Location

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 12, 2024
• Study Start: April 2, 2023
• Primary Completion: May 5, 2024
• Study Completion: June 6, 2024
• Last Updated: June 12, 2024

Record last verified: 2024-06

Locations

CN (1)