Comparing standard and mini procedures for kidney stone treatment
Randomized Controlled Trial Comparing Surgical Outcomes Following PCNL and Mini PCNL in the Treatment of Kidney Stones
This study is testing whether a standard kidney stone surgery works better or has fewer complications than a smaller version of the same surgery for people with kidney stones.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04069013 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized controlled trial that compares the outcomes and complications of standard percutaneous nephrolithotomy (PCNL) with mini-PCNL for patients with renal stones. Participants who have consented to undergo PCNL will be randomly assigned to receive either the standard or mini version of the procedure. The study will collect pre-operative and post-operative quality of life data and additional blood samples to assess inflammation factors. It involves multiple academic medical centers in the United States and Canada as part of the EDGE research consortium.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for PCNL and have kidney stones sized between 10-20mm.
Not a fit: Patients who require conversion to open surgery, have multiple access tracts, or have anticoagulation issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing kidney stone treatment.
How similar studies have performed: Previous studies have shown promising results with mini-PCNL approaches, indicating potential benefits over standard techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients planned for PCNL at participating institutions * Age ≥ 18 years old * Male and female patients * Patients of all ethnic backgrounds * Stone size 10-20mm Patients must be capable of giving informed consent and must be capable and willing to enroll and participate fully with the study. Exclusion Criteria: * Conversion to open procedure * Multiple access tracts * Anticoagulated or history of coagulopathy * Preoperative ureteral stent or nephrostomy tube placement * Technical problems/impossibility of localizing the stone on the day of intervention Patients unable to give informed consent or unwilling to enroll or participate in the study will be excluded.
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Manoj Monga, MD — The Cleveland Clinic
- Study coordinator: Manoj Monga, MD
- Email: mongam@ccf.org
- Phone: 216-445-8678
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.