Kidney Calculi
Conditions
Keywords
Kidney stone removal surgery
Brief summary
The patient will be asked to participate in a research project designed to determine the best way to prevent bleeding and promote patient comfort after having kidney stones removed. Two standard methods for ending the surgery are being compared to a newer method. In one standard method, the patient will have a tube draining urine from the kidney after the procedure. This tube may also prevent bleeding from the kidney. In another standard method the patient will have a tube left internally that drains urine from the kidney to the bladder and a stitch will be used to close the incision and deeper tissues in the back. In the third potential option, a tube would be left internally to drain urine from the kidney to the patient's bladder and the surgical site would be filled with a clot promoting agent (FloSeal) which is a FDA approved agent specifically formulated to stop bleeding during surgical procedures.
Interventions
PROCEDUREFloseal
Bioglue that seals the kidney
PROCEDURECope Loop
Nephrostomy tube for fluid drainage from the kidney
PROCEDUREFascial Stitch
Stitch that closes the kidney
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient has kidney stones that require treatment (tx) with percutaneous stone removal * 18 years of age or over
Exclusion criteria
* Patient mentally impaired, have a chronic pain syndrome or disorder, or any condition that might alter the sensation of pain * Patient taking coumadin * Pre-existing percutaneous nephrostomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine which method of treatment causes the least pain to the patient. | one month |
Countries
United States
Outcome results
None listed