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Completed

NCT Number: NCT07522619

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

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.

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Key information

Conditions

Renal Stones Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indus Hospital and Health Network

Karachi, Sindh, 74900, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 to 80 years
  • Renal stones greater than 1.5 cm
  • Schedule for percutaneous nephrolithotomy (PCNL)
  • Ability to provide informed consent

Exclusion criteria

  • Congenital anatomical renal abnormalities
  • Known bleeding disorders
  • Pelvicalyceal system perforation
  • Refusal or inability to provide informed consent

Treatment and study plan

Standard Percutaneous Nephrolithotomy (Standard PCNL)

Procedure

Percutaneous nephrolithotomy (PCNL) is performed with placement of a nephrostomy tube at the end of the procedure.

Tubeless Percutaneous Nephrolithotomy (Tubeless PCNL)

Procedure

Percutaneous nephrolithotomy (PCNL) is performed without placement of a nephrostomy tube at the end of the procedure.

Other names: Nephrostomy-Free Percutaneous Nephrolithotomy

Primary outcomes

  1. Stone-Free Rate (SFR)

    Time frame: 4 weeks postoperatively

    Proportion of patients with no residual renal stones or clinically insignificant fragments (<4 mm) confirmed on postoperative imaging.

  2. Postoperative Pain Score

    Time frame: 6 hours, 12 hours, and 24 hours postoperatively.

    Visual Analogue Scale (VAS), a 100 mm scale ranging from 0 mm (no pain) to 100 mm (worst imaginable pain), where higher scores indicate worse pain.

Secondary outcomes

  1. Operative Time

    Time frame: During the surgical procedure (from skin incision to completion of procedure)

    Total duration of the surgical procedure measured in minutes from skin incision to completion of the procedure.

  2. Time to First Pain Complaint

    Time frame: From end of surgery to first reported pain, assessed up to 24 hours postoperatively

    Time from completion of surgery to the first reported pain by the patient, measured in hours.

  3. Length of Hospital Stay

    Time frame: From admission to discharge, assessed up to 5 days

    Total duration of a hospital stay is measured in days from admission to discharge.

  4. Analgesia Requirement

    Time frame: From end of surgery up to 24 hours postoperatively

    Requirement of rescue analgesia (intravenous Tramadol 50 mg) administered when the Visual Analogue Scale (VAS) score exceeded 43 mm.

Sponsors and collaborators

Lead sponsor

Indus Hospital and Health Network

Other

Registry information

Official study title

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

Acronym: TPCNL

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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