Clinical trial NCT04690010: Ambulatory Versus Inpatient Percutaneous Nephrolithotomy
Official title: A Randomized Controlled Trial of Ambulatory Versus Inpatient Percutaneous Nephrolithotomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Kidney Calculi
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Queen's University
First posted: 2020-12-30
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of the study is to determine if ambulatory tubeless PCNL is safe and effective compared to inpatient PCNL with a nephrostomy tube.

Detailed description: One in eight human beings will develop kidney stones during their lifetime. Of these, roughly 20% require surgery. Percutaneous nephrolithotomy (PCNL) is the standard minimally invasive surgical procedure for removal of large kidney stones. In the standard PCNL technique, a drainage tube connecting the kidney to a bag on the outside of the body (nephrostomy tube) is left in place after surgery. Patients are admitted to hospital for one to two days for observation at which time the nephrostomy tube is removed before discharge. The presence of the nephrostomy tube is associated with pain, increased use of opioids, and slower recovery after surgery.

Ambulatory PCNL has been proposed as a way to potentially speed recovery, reduce pain, decrease time in hospital, and decrease cost. Initial studies of ambulatory tubeless PCNL have shown favourable results. However, these studies were performed in a small subset of healthy patients with favourable stones that do not represent the majority of patients who undergo PCNL. In this technique, patients are discharged home the same day as surgery usually with a small drainage tube on the inside of the body called a stent that is removed 1-2 weeks later and no nephrostomy tube (tubeless). The stent itself can be painful and may require a second procedure for removal. There is increasing evidence for the safety of totally tubeless PCNL (in which no nephrostomy tube or ureteric stent is placed) or placement of a stent on a string for a short period of time. Given that current recommendations for stone management in the times of COVID-19 include minimizing use of stents, the investigators believe it is an optimal time to evaluate safety and efficacy of using a minimal stenting technique (either no stent at all or stent on string) in ambulatory PCNL patients.

The goal of the study is to determine if ambulatory tubeless PCNL is safe and effective compared to inpatient PCNL with a nephrostomy tube in a more representative patient population including obese patients, patients with moderate medical comorbidities, and patients with large kidney stones. A secondary aim is to determine if a minimal stent technique (stent on a string for 5 days or less or no stent) is safe and effective as an exit strategy in ambulatory PCNL patients. The study hypothesis is that ambulatory tubeless PCNL will have similar complication and stone free rates as inpatient PCNL with benefits over inpatient PCNL including improved patient quality of life, decreased use of opioid pain medications, shortened hospital admission, faster return to work, and lower cost.

Eligibility criteria: Inclusion Criteria:

* Scheduled for PCNL who agree to be included in the study
* Age 18 years or more
* Absence of renal anatomic abnormalities
* Patients undergoing bilateral procedures or those with pre-operative indwelling ureteral stents or nephrostomy tubes will be included

Exclusion Criteria:

Pre-operative:

* Age \<18
* Pregnancy
* Positive urine culture within 3 weeks
* Bleeding disorder
* Presence of renal anatomic abnormalities
* Solitary kidney
* Need for admission based on comorbidities determined by anesthesiologist

Intra-operative:

* Significant ureteral or pelvicalyceal injury
* Significant intraoperative hemorrhage

Post-operative:

* Temperature \>100.4 Fahrenheit
* Hemodynamic instability (defined as 2 of 3: heart rate \>90 beats per minute, respiratory rate \>20 breaths per minute, systolic blood pressure \<90mmHg, or drop in systolic blood pressure \>40mmHg)
* Hemoglobin drop of \> 3 g/dL compared to pre-operative bloodwork
* Transfusion of blood products
* Pneumothorax or hemothorax on chest X ray
* Uncontrolled nausea, vomiting, or pain

Primary outcomes:
measure: Total number of complications
timeFrame: 4 weeks after surgery
Secondary outcomes:
measure: Stone free status
timeFrame: 4 weeks after surgery
measure: Change in Wisconsin Stone Quality of Life Questionnaire by 10 points or more from baseline to 4 weeks after surgery.
timeFrame: This will be completed at the initial visit (baseline) and at the follow-up visit 4 weeks later.
measure: Cumulative opiate morphine equivalent dosing
timeFrame: 4 weeks after surgery
measure: Return to work
timeFrame: 4 weeks after surgery
measure: Time in hospital
timeFrame: 1 week after surgery
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Thomas Chi, MD
role: PRINCIPAL_INVESTIGATOR
References: