Randomized Controlled Trial to Compare the Operative Outcomes and Complications of Mini-Percutaneous Nephrolithotomy (mini-PCNL) Versus Standard PCNL
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 19-006317
NCT ID: NCT04767919
Sponsor Protocol Number: 19-006317
About this study
The purpose of this study is to compare the operative outcomes and complications of mini-percutaneous nephrolithotomy (mini-PCNL) versus standard PCNL for renal stones.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients with planned PCNL and a preoperative CT scan.
- Urologist obtained access and prone positioning during surgery.
- Tract dilation performed either using balloon dilator or a single step mini-PCNL dilation.
- Age: ≥ 18 years old.
- Stone size: 10-25mm.
- Male and female patients.
- Patients of all ethnic backgrounds.
- Capable of giving informed consent.
- Capable and willing to fulfill the requirements of the study.
- Pre-existing indwelling nephrostomy tube or ureteral stent permitted.
Exclusion Criteria:
- Anticoagulated or history of coagulopathy (with the exception of daily 81 mg aspirin).
- Conversion to open procedure.
- Multiple access tracts.
- Inability to give informed consent or unable to meet requirements of the study for any reason.
Eligibility last updated 9/21/21. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Mitchell Humphreys, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available