Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Renal stone disease is a common urological condition associated with significant morbidity. Percutaneous nephrolithotomy (PCNL) is the standard treatment for renal stones larger than 2 cm. Although standard PCNL (Percutaneous nephrolithotomy) is associated with high stone-free rates, it carries a risk of complications such as bleeding and prolonged hospital stay. Mini percutaneous nephrolithotomy has been introduced as a less invasive alternative with the potential to reduce morbidity. However, evidence comparing outcomes between mini-PCNL (Percutaneous nephrolithotomy) and standard PCNL (Percutaneous nephrolithotomy) remains inconsistent, particularly in the local population. This randomized controlled trial aims to compare operative and postoperative outcomes of mini-PCNL versus standard PCNL in patients with renal stones.
Percutaneous nephrolithotomy is the preferred surgical intervention for large renal calculi. Despite its effectiveness, standard PCNL is associated with complications including hemorrhage, postoperative pain, and prolonged hospitalization. Mini-PCNL utilizes a smaller tract size, potentially reducing parenchymal injury and blood loss while maintaining adequate stone clearance. Previous studies have reported conflicting results regarding operative time, stone-free rates, and complications between the two techniques. Additionally, limited data are available from Pakistan. This randomized controlled trial will compare operative time, hemoglobin drop, stone clearance, postoperative fever, and length of hospital stay between mini-PCNL and standard PCNL, with the aim of identifying the safer and more effective approach for renal stone management.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mini Percutaneous Nephrolithotomy | Experimental | Patients will undergo Mini Percutaneous Nephrolithotomy using an 11-13 Fr Amplatz sheath and Semi-rigid Ureteroscope for stone fragmentation and removal. |
|
| Standard Percutaneous Nephrolithotomy | Active Comparator | Patients will undergo Standard Percutaneous Nephrolithotomy using a 30 Fr Amplatz sheath and Standard Nephroscope. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mini Percutaneous Nephrolithotomy | Procedure | Mini-PCNL (Percutaneous nephrolithotomy) performed under general anesthesia using small-caliber tract dilation and Pneumatic lithotripsy. |
| Measure | Description | Time Frame |
|---|---|---|
| Operative Time | Duration of operative time measured in minutes from renal puncture to skin closure. | From renal puncture to skin closure during the index surgical procedure |
| Stone Clearance Rate | Absence of residual stones on X-ray KUB ( Kidney, Ureter, Bladder) or ultrasonography at the time of discharge. | Assessed at 1 week post-procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin Drop | Difference between preoperative and postoperative hemoglobin levels (g/dL). | Preoperqtively and 24 hours post-procedure. |
| Postoperative Fever | Body temperature >101°F. |
Not provided
Eligibility Criteria
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr Hazrat Ullah, MBBS, FCPS | Khyber Teaching Hospital Peshawar | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Khyber Teaching Hospital Peshawar | Peshawar | KhyberPakhtunkhwa | 25000 | Pakistan |
Data sharing plans have not been finalized . However, Individual participant data might not be shared due to institutional policy and absence of a formal data-sharing framework. But this will depend on journal requirements, funding agency policies.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard Percutaneous Nephrolithotomy | Procedure | Standard PCNL performed under general anesthesia using conventional tract dilation and Nephroscope-assisted stone removal. |
|
| Post procedure up to 24 hours. |
| Length of Hospital Stay | Measured in days. | through hospital discharge, an average of 3 days |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |