Loyola University Medical Center
Maywood, Illinois, 60153, United States
NCT Number: NCT04556396
Percutaneous nephrolithotomy (PCNL) is a first-line treatment for kidney stones >2cm. Frequently, patients require multiple procedures to address their stone burden. The decision to proceed with a second-look procedure is based on follow-up CT imaging, which is obtained postoperatively. In this study, we propose the use of a portable CT scan technology to obtain follow-up imaging while the patient is still under anesthesia for the initial procedure. The goal of this study is to determine whether this allows the surgeon to identify residual fragments and render the patient stone-free within a single anesthetic event.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Maywood, Illinois, 60153, United States
Percutaneous nephrolithotomy (PCNL) is considered a first-line management option for kidney stones larger than two centimeters. Unfortunately, because of the large stone burden, up to 70% of these patients are left with residual stone fragments after their initial PCNL. Additionally, an estimated 20% to 60% of such patients ultimately require further interventions due to residual stone fragments. The need for a subsequent procedure is determined by postoperative abdominal computed tomography (CT) imaging, which is routinely performed on the first postoperative day at this institution. The decision to proceed with a second procedure is based on findings from this postoperative CT scan.
Cone-beam CT (CBCT) is a novel portable imaging technique that can allow cross-sectional imaging to be obtained intraoperatively, rather than post-operatively. Incorporating this modality would allow the surgeon to determine whether the procedure should be continued, in the event of residual fragments, or if it can be safely concluded. This would obviate the need for dedicated postoperative CT scans and, more importantly, reduce the need for subsequent procedures and consequently decrease the patient's length of stay.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
On-table CT scan in the operating room to determine residual kidney stone burden at end of procedure
Other names: O-arm, Intraoperative CT
Time frame: 90 days
The percentage of patients requiring subsequent surgical intervention to remove residual stones
Time frame: 90 days
The average length of inpatient hospital stay in days
Time frame: 90 days
The percentage of patients experiencing Clavien-Dindo Grade III-V complications (major) related to the patients' surgery.
Time frame: 90 days
The percentage of patients who are rendered without residual kidney stone burden after their surgery based on CT scan
Time frame: 90 days
The percentage of patients who presented with symptoms of renal obstruction following their surgery
Loyola University
Other
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