A clinical trial to study and compare two minimal invasive stone removal procedures for kidney stones, mini PCNL with attached suction vs standard mini PCNL

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2023
INTERVENTION: Intervention1: Suction assisted mini PCNL: 16 Fr suction sheath and 12 Fr mini‐nephroscope will be used for percutaneous kidney stone removal .Patients will be followed in immediate post operative period with Xray KUB to look for residual fragments and tube / stent status and at one month with a NCCT KUB for final stone free rate calculation.Duration of follow up will be 1 month. Control Intervention1: Standard mini PCNL: 16 Fr sheath will be inserted without attached suction.Patients will be followed in immediate post operative period with Xray KUB to look for residual fragments and tube / stent status and at one month with a NCCT KUB for final stone free rate calculation. CONDITION: Health Condition 1: N202‐ Calculus of kidney with calculus of ureter PRIMARY OUTCOME: 1. To study and compare operation time and lithotripsy time ; 2. To study and compare intra renal pressure changes during PCNL ; 3. To study and compare stone free rate (SFR)Timepoint: Duration of hospital stay and follow up after one month SECONDARY OUTCOME: To study and compare postoperative fever, sepsis and other complications such as haemoglobin drop, transfusion requirement, postoperative pain and hospital stayTimepoint: Duration of hospital stay INCLUSION CRITERIA: 1. Patients of kidney stones desirous of percutaneous renal stone removal. 2. Kidney stones 1‐4 cm in size. 3. Age 18‐70 years. 4. ASA score I‐II.
Epistemonikos ID: 9f9b9bd294edea72bd8c8951beb643e3a70dae43
First added on: Feb 20, 2024