The Perioperative Outcomes of Papillary Versus Non-Papillary Access in Percutaneous Nephrolithotomy: Results from a prospective randomized trial
Phase 1
Recruiting
- Conditions
- Urological and Genital Diseases
- Registration Number
- PACTR202308603946944
- Lead Sponsor
- Tanta University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
All adult patients with renal stones who are fit for surgical intervention and planned to have PCNL.
Exclusion Criteria
• Patients who are unfit for surgery due to chronic debilitating diseases (e.g., severe hepatic cirrhosis), uncorrectable bleeding diathesis or immunodeficiency syndromes.
• Patients with solitary kidney or single functioning kidney.
• Patients with congenital anatomical variants (horseshoe kidney or
ectopic kidney).
• Patients with chronic renal impairment of serum creatinine > 2 mg/dL
• Patients who refuse surgery.
• Pregnant females.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The aim of this study is to prospectively compare the perioperative outcomes of the standard papillary and the non-papillary accesses in cases of percutaneous nephrolithotomy in terms of safety, feasibility, and efficacy. The primary outcome is safety of the technique, whichwhich will be evaluated by assessing the perioperative complications’ rate and type including fever, elevation of serum creatinine, hemoglobin drop, blood transfusion, injury to the lungs or bowel or other abdominal organs, persistent nephrocutaneous fistula, infundibular stenosis and death.
- Secondary Outcome Measures
Name Time Method Feasibility will be assessed by calculating the success rate of obtaining an access and the fluoroscopy time passed till puncture is made.;Efficacy will be measured by recording the one-month stone free rate in each arm and the need for any auxiliary procedures.