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

April 8, 2026 updated by: Dr. Mubeen Iqbal, Indus Hospital and Health Network

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74900
        • Indus Hospital and Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard PCNL
Patients undergo standard percutaneous nephrolithotomy (PCNL) with placement of a nephrostomy tube at the end of the procedure.
Procedure: Standard Percutaneous Nephrolithotomy (Standard PCNL)
Percutaneous nephrolithotomy (PCNL) is performed with placement of a nephrostomy tube at the end of the procedure.
Experimental: Tubeless PCNL
Patients undergo tubeless percutaneous nephrolithotomy (PCNL) without placement of a nephrostomy tube.
Procedure: Tubeless Percutaneous Nephrolithotomy (Tubeless PCNL)
Percutaneous nephrolithotomy (PCNL) is performed without placement of a nephrostomy tube at the end of the procedure.
Other Names:
  • Nephrostomy-Free Percutaneous Nephrolithotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks postoperatively
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.
6 hours, 12 hours, and 24 hours postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the surgical procedure (from skin incision to completion of procedure)
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.
From end of surgery to first reported pain, assessed up to 24 hours postoperatively
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.
From admission to discharge, assessed up to 5 days
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.
From end of surgery up to 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indus Hospital and Health Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2021

Primary Completion (Actual)

May 23, 2022

Study Completion (Actual)

May 23, 2022

Study Registration Dates

First Submitted

March 29, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUBELESS-PCNL-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to institutional policies, patient confidentiality concerns, and lack of formal data-sharing agreements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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