The objective of the study is to compare the stone free rates with ureteroscopy utilizing the ClearPETRA suction ureteral access sheath, and mini-PCNL; both procedures and ClearPETRA sheaths are standard of care and are used regularly for stone treatment. Our primary objective is to assess the complete stone free rate with both procedures.
With the advent of mini-PCNLs, some endourologists have been utilizing the technique to treat renal calculi up to 3cm in size with better stone free rates and similar comorbidity compared to ureteroscopy. These procedures require percutaneous renal access, and it is associated with greater length of stay and fluoroscopy time. The ClearPETRA ureteral access sheath has shown great promise with improving stone free rates, decreasing intra-renal pressure and delivering some of the benefits of mini-PCNL without the added risk associated with obtaining percutaneous renal access. The ClearPETRA flexible suction ureteral access sheath anecdotally improves efficiency and allows endourologists to better clear stone debris when compared to traditional ureteral access sheaths. We have yet to see a comparison between suction ureteral access sheaths and mini-PCNL with the suction renal access sheath. Study Hypothesis: Compared to traditional access sheaths, using ClearPETRA access sheaths will result in an improvement in stone free rates with both modalities, with lower complications. Using ClearPETRA access sheaths in both modalities compared to traditional access sheaths should result in less of a difference in stone free rates between the ureteroscopy group and the mini-PCNL group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Ureteroscopy utilizing the ClearPETRA suction access sheath.
Mini-PCNL utilizing the ClearPETRA suction access sheath
Northwestern Memorial Hospital
Chicago, Illinois, United States
Stone free rate
Stone free rate (no residual stone) on post-procedure CT
Time frame: 4 weeks post-procedure
Surgery time
Surgery time (minutes)
Time frame: Procedure day (1 day)
Complication rate
Complication rate (Clavien-Dindo) (%)
Time frame: Procedure day (1 day)
Unplanned hospital visits
Unplanned hospital visits (ED/clinic)
Time frame: 90 days postoperatively
Need for additional procedure
Need for additional procedure (within 90 days postoperatively)
Time frame: 90 days postoperatively
Length of stay
Length of stay hospital stay (if admitted post-procedure, or readmitted)
Time frame: Perioperatively (starting at Baseline/Procedure Date)
Inability to access ureter
Intra-operative complications including inability to access the ureter ureteroscopically or need to upsize the renal access sheath with the percutaneous approach.
Time frame: Procedure day (1 day)
Need to upsize from 18Fr Sheath
Need to upsize from 18Fr (PCNL group)
Time frame: Procedure day (1 day)
Occurrence of post-procedure sepsis
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Post-op sepsis
Time frame: Perioperatively (starting at Baseline/Procedure Date)
Hospital / patient costs (in total for procedure and any necessary postoperative hospital admissions or procedures related to the initial procedure).
Any necessary postoperative hospital admissions or procedures related to the initial procedure
Time frame: Perioperatively (starting at Baseline/Procedure Date)