NCT07522619

Comparison of Tubeless Versus Standard Percutaneous Nephrolithotomy (PCNL) for Renal Stones

A Randomized Controlled Trial Comparing Postoperative Pain and Analgesia Requirement Between Tubeless and Standard Percutaneous Nephrolithotomy (PCNL)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Indus Hospital and Health Network · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Percutaneous nephrolithotomy (PCNL) is the surgery usually done to break down kidney stones that are larger than 1.5 cm. Placing a nephrostomy tube after the surgery to drain urine is a common aspect of traditional PCNL. This tube placement is associated with post-op pain and discomfort. In tubeless PCNL, the nephrostomy tube is not placed, which may lessen pain and speed up recovery. In this randomized controlled trial, the primary objective is to assess the pain and analgesia requirements of patients at different time points after surgery who have undergone a standard PCNL or a tubeless PCNL. Secondary parameters will be recorded, like surgical time, duration of hospital stay, and time interval before the first complaint of pain. Results from this research will offer advice about whether tubeless PCNL can be considered a safe and patient-friendly option as compared to the standard method.

Detailed description

Percutaneous nephrolithotomy (PCNL) is the main surgical option for the management of big kidney stones. Traditionally, a nephrostomy tube is inserted at the end of the operation to allow drainage and provide the opportunity for re-intervention. On the other hand, nephrostomy tubes are believed to cause more postoperative pain and patient discomfort. Tubeless PCNL, which means that the nephrostomy tube is left out while internal drainage is maintained with a ureteral stent, has been suggested as a method to lessen postoperative morbidity. Although more and more studies indicate that it is safe and effective, some people are still not sure because of possible complications, for example, urinary leakage and the need for additional surgery. The research was set up as a prospective randomized controlled trial at a tertiary care hospital. Researchers recruited and randomized sixty (60) patients aged 18 to 80 years with renal stones greater than 1.5 cm into two groups: standard PCNL and tubeless PCNL. The randomization was done using the SNOSE method, which uses sequentially numbered opaque sealed envelopes. General anesthesia was used during all operations. Two consultant urologists who have wide experience in this field performed the operations. While the standard PCNL group ended up with a nephrostomy tube at the end of the operation, the tubeless PCNL group did not get any nephrostomy tube. The main variable was postoperative pain intensity, which was measured on a visual analogue scale (VAS) at 6, 12, and 24 hours. Other variables were operative time, time to first pain complaint, length of hospital stay, and analgesia requirements. The study's goal is to provide information about how well tubeless PCNL can reduce postoperative pain without affecting clinical outcomes compared to standard PCNL, especially in a situation where resources are limited.

Conditions

• Renal Stones
• Postoperative Pain

Interventions

Type	Name	Description
PROCEDURE	Standard Percutaneous Nephrolithotomy (Standard PCNL)	Percutaneous nephrolithotomy (PCNL) is performed with placement of a nephrostomy tube at the end of the procedure.
PROCEDURE	Tubeless Percutaneous Nephrolithotomy (Tubeless PCNL)	Percutaneous nephrolithotomy (PCNL) is performed without placement of a nephrostomy tube at the end of the procedure.

Timeline

• Start date: 2021-11-24
• Primary completion: 2022-05-23
• Completion: 2022-05-23
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: Pakistan