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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard PCNL | Active Comparator | Patients undergo standard percutaneous nephrolithotomy (PCNL) with placement of a nephrostomy tube at the end of the procedure. |
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| Tubeless PCNL | Experimental | Patients undergo tubeless percutaneous nephrolithotomy (PCNL) without placement of a nephrostomy tube. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Percutaneous Nephrolithotomy (Standard PCNL) | Procedure | Percutaneous nephrolithotomy (PCNL) is performed with placement of a nephrostomy tube at the end of the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Stone-Free Rate (SFR) | Proportion of patients with no residual renal stones or clinically insignificant fragments (<4 mm) confirmed on postoperative imaging. | 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. | 6 hours, 12 hours, and 24 hours postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Operative Time | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indus Hospital and Health Network | Karachi | Sindh | 74900 | Pakistan |
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|---|---|
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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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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.
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Due to the nature of the surgical intervention, blinding participants, care providers, and outcome assessors was not feasible.
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| Tubeless Percutaneous Nephrolithotomy (Tubeless PCNL) | Procedure | Percutaneous nephrolithotomy (PCNL) is performed without placement of a nephrostomy tube at the end of the procedure. |
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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 | 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 | 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 |
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| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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