Urolithiasis Clinical Trial
Official title:
Mini- Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in the Treatment of Renal Stones. A Randomized Controlled Trial
Verified date | November 2019 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The EUA Urolithiasis Guidelines Panel meta-analysis suggest that mPNL is at least as
efficacious and safe as sPNL for the removal of renal calculi. However, the quality of the
evidence was poor, drawn mainly from small studies, the majority of which were single-arm
case series, and only one of which was RCT. The risks of bias and confounding were high,
highlighting the need for more reliable data from RCTs. So, the Panel recommended for more
clinical research .
The aim of this study is to compare between PNL and mPNL through a randomized controlled
trial.
Status | Active, not recruiting |
Enrollment | 210 |
Est. completion date | May 1, 2021 |
Est. primary completion date | May 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patient 18 years or older. 2. ASA I or II 3. Renal stones = 2 cm 4. Lower calyceal stone = 1 cm 5. Failure of other modalities of treatment as ESWL and RIRS. Exclusion Criteria: 1. S.creatinine > 2mg/dl. 2. Patients with active UTI. 3. Patients on anticoagulant. 4. Age <18 years. 5. Ureteral obstruction preventing the insertion of a ureteral stent. |
Country | Name | City | State |
---|---|---|---|
Egypt | Urology and Nephrology Center | Mansoura | Aldakahlia |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of stone free rate (SFR) | defined as less than 4mm by non contrast computed tomography | 2 years | |
Secondary | assessment of haemoglobin loss | measured by haemoglobin change pre and postoperative (measured by grams/ deciliter) | 2 years | |
Secondary | assessment of pain | measured by visual analogue scale | 2 years | |
Secondary | assessment of renal function | measured by serum creatinine measured by Milligram/ deciliter | 2 years | |
Secondary | assessment of patient satisfaction | measured by freiburg index of patient satisfaction | 2 years |
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