Renal StonesTPCNLNCT07522619
Comparison of Tubeless Versus Standard Percutaneous Nephrolithotomy (PCNL) for Renal Stones
A study testing Standard Percutaneous Nephrolithotomy (Standard PCNL) and Tubeless Percutaneous Nephrolithotomy (Tubeless PCNL) in people with Renal Stones and Postoperative Pain, run by Indus Hospital and Health Network at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Stones, Postoperative Pain
- What is being tested?
- Standard Percutaneous Nephrolithotomy (Standard PCNL) and Tubeless Percutaneous Nephrolithotomy (Tubeless PCNL)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Nov 2021to 23 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years
- Renal stones greater than 1.5 cm
- Schedule for percutaneous nephrolithotomy (PCNL)
- Ability to provide informed consent
Who cannot join
- Congenital anatomical renal abnormalities
- Known bleeding disorders
- Pelvicalyceal system perforation
- Refusal or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Standard Percutaneous Nephrolithotomy (Standard PCNL), Tubeless Percutaneous Nephrolithotomy (Tubeless PCNL)
- Keywords
- Tubeless PCNL, Postoperative Pain, Nephrostomy Tube
- Medical subject headings
- Nephrolithiasis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Percutaneous Nephrolithotomy (Standard PCNL)Procedure or surgery
Percutaneous nephrolithotomy (PCNL) is performed with placement of a nephrostomy tube at the end of the procedure.
Tubeless Percutaneous Nephrolithotomy (Tubeless PCNL)Procedure or surgery
Also called Nephrostomy-Free Percutaneous Nephrolithotomy
Percutaneous nephrolithotomy (PCNL) is performed without placement of a nephrostomy tube at the end of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Standard PCNL | Active comparator | Patients undergo standard percutaneous nephrolithotomy (PCNL) with placement of a nephrostomy tube at the end of the procedure. Receives: Procedure: Standard Percutaneous Nephrolithotomy (Standard PCNL) |
| Tubeless PCNL | Experimental | Patients undergo tubeless percutaneous nephrolithotomy (PCNL) without placement of a nephrostomy tube. Receives: Procedure: Tubeless Percutaneous Nephrolithotomy (Tubeless PCNL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-Free Rate (SFR)
Proportion of patients with no residual renal stones or clinically insignificant fragments (<4 mm) confirmed on postoperative imaging.
Measured: 4 weeks postoperatively
Postoperative Pain Score
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.
Measured: 6 hours, 12 hours, and 24 hours postoperatively.
Secondary outcomes (4)
Operative Time
Total duration of the surgical procedure measured in minutes from skin incision to completion of the procedure.
Measured: During the surgical procedure (from skin incision to completion of procedure)
Time to First Pain Complaint
Time from completion of surgery to the first reported pain by the patient, measured in hours.
Measured: From end of surgery to first reported pain, assessed up to 24 hours postoperatively
Length of Hospital Stay
Total duration of a hospital stay is measured in days from admission to discharge.
Measured: From admission to discharge, assessed up to 5 days
Analgesia Requirement
Requirement of rescue analgesia (intravenous Tramadol 50 mg) administered when the Visual Analogue Scale (VAS) score exceeded 43 mm.
Measured: From end of surgery up to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start24 Nov 2021
- Primary completion23 May 2022
- Study completion23 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups of participants were randomly assigned to receive either tubeless percutaneous nephrolithotomy (PCNL) without a nephrostomy tube or standard PCNL with a nephrostomy tube. Outcomes were compared between the two groups.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indus Hospital and Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mubeen Iqbal, Indus Hospital and Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522619
- Sponsor's protocol ID
- TUBELESS-PCNL-2026
- Acronym
- TPCNL
- Status last verified
- Apr 2026
- First submitted
- 29 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to institutional policies, patient confidentiality concerns, and lack of formal data-sharing agreements.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Postoperative Pain and Analgesia Requirement Between Tubeless and Standard Percutaneous Nephrolithotomy (PCNL)
- ClinicalTrials.gov ID
- NCT07522619
- Acronym / sponsor ID
- TPCNL / TUBELESS-PCNL-2026
- Conditions
- Renal Stones, Postoperative Pain
- Keywords
- Tubeless PCNL, Postoperative Pain, Nephrostomy Tube
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Indus Hospital and Health NetworkUniversity, hospital or other
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 23 May 2022 (actual)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel groups of participants were randomly assigned to receive either tubeless percutaneous nephrolithotomy (PCNL) without a nephrostomy tube or standard PCNL with a nephrostomy tube. Outcomes were compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Standard PCNL | Active comparator | Procedure: Standard Percutaneous Nephrolithotomy (Standard PCNL)Patients undergo standard percutaneous nephrolithotomy (PCNL) with placement of a nephrostomy tube at the end of the procedure. |
| Tubeless PCNL | Experimental | Procedure: Tubeless Percutaneous Nephrolithotomy (Tubeless PCNL)Patients undergo tubeless percutaneous nephrolithotomy (PCNL) without placement of a nephrostomy tube. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 80 years
- Renal stones greater than 1.5 cm
- Schedule for percutaneous nephrolithotomy (PCNL)
- Ability to provide informed consent
Key exclusion criteria (4 listed)
- Congenital anatomical renal abnormalities
- Known bleeding disorders
- Pelvicalyceal system perforation
- Refusal or inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Percutaneous Nephrolithotomy (Standard PCNL)Percutaneous nephrolithotomy (PCNL) is performed with placement of a nephrostomy tube at the end of the procedure. | Procedure or surgery | Standard PCNL |
| Tubeless Percutaneous Nephrolithotomy (Tubeless PCNL)Also: Nephrostomy-Free Percutaneous NephrolithotomyPercutaneous nephrolithotomy (PCNL) is performed without placement of a nephrostomy tube at the end of the procedure. | Procedure or surgery | Tubeless PCNL |
Primary outcome
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.
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.
4 secondary outcomes
Operative Time
Time frame: 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
Length of Hospital Stay
Time frame: From admission to discharge, assessed up to 5 days
Analgesia Requirement
Time frame: From end of surgery up to 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to institutional policies, patient confidentiality concerns, and lack of formal data-sharing agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Percutaneous Nephrolithotomy (Standard PCNL) and Tubeless Percutaneous Nephrolithotomy (Tubeless PCNL) in people with Renal Stones and Postoperative Pain, run by Indus Hospital and Health Network at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone-Free Rate (SFR) (time frame: 4 weeks postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.