Ambulatory Versus Inpatient Percutaneous Nephrolithotomy
Primary Purpose
Kidney Calculi
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ambulatory tubeless PCNL
Inpatient PCNL with nephrostomy tube
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Calculi
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
Sites / Locations
- University of California, San FranciscoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ambulatory tubeless PCNL
Inpatient PCNL with nephrostomy tube
Arm Description
Patients will be discharged home on the same day as surgery. No nephrostomy tube will be placed (tubeless).
Patients will be admitted to hospital for 1-3 days with a nephrostomy tube placed at the time of surgery that will then be removed prior to discharge.
Outcomes
Primary Outcome Measures
Total number of complications
Any of: Emergency department visits related to procedure, unplanned provider visits, re-admission related to the procedure, blood transfusion, and need for secondary procedures. Patients with an emergency department or provider visit leading to re-admission will be classified once in the primary outcome as re-admission.
Secondary Outcome Measures
Stone free status
Stone free status will be defined as no residual stones with maximum diameter >3 mm on low dose non-contrast CT scan at 4 weeks post-surgery.
Change in Wisconsin Stone Quality of Life Questionnaire by 10 points or more from baseline to 4 weeks after surgery.
The Wisconsin Stone Quality of Life Questionnaire is a validated, disease specific quality-of-life instrument that has been used in the acute, chronic, and post-operative setting and is currently the most commonly used questionnaire for kidney stone disease.The survey is a 28-item instrument with a 5-point Likert scale for each item. There is a total of 140 points, and a difference of 10 points is considered clinically significant.
Cumulative opiate morphine equivalent dosing
This will be the calculated as the morphine equivalent dosage of all opioid medications taken by patients from time of surgery to follow-up at 4 weeks above their baseline opioid needs.
Return to work
Mean time to return to work (in days) and percent who have returned to work at 1 week will be determined at the time of the 4-week follow-up visit.
Time in hospital
Duration spent in hospital (in hours) will be determined
Full Information
NCT ID
NCT04690010
First Posted
December 28, 2020
Last Updated
September 13, 2022
Sponsor
University of California, San Francisco
Collaborators
Queen's University
1. Study Identification
Unique Protocol Identification Number
NCT04690010
Brief Title
Ambulatory Versus Inpatient Percutaneous Nephrolithotomy
Official Title
A Randomized Controlled Trial of Ambulatory Versus Inpatient Percutaneous Nephrolithotomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 8, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Queen's University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Calculi
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ambulatory tubeless PCNL
Arm Type
Active Comparator
Arm Description
Patients will be discharged home on the same day as surgery. No nephrostomy tube will be placed (tubeless).
Arm Title
Inpatient PCNL with nephrostomy tube
Arm Type
Active Comparator
Arm Description
Patients will be admitted to hospital for 1-3 days with a nephrostomy tube placed at the time of surgery that will then be removed prior to discharge.
Intervention Type
Procedure
Intervention Name(s)
Ambulatory tubeless PCNL
Intervention Description
Patients will be discharged the same day of surgery. No nephrostomy tube will be left in place. A ureteral stent on a string may be left for up to 5 days.
Intervention Type
Procedure
Intervention Name(s)
Inpatient PCNL with nephrostomy tube
Intervention Description
Patients will be admitted to hospital for 1-3 days. A nephrostomy tube will be placed at the time of surgery that will be removed prior to discharge.
Primary Outcome Measure Information:
Title
Total number of complications
Description
Any of: Emergency department visits related to procedure, unplanned provider visits, re-admission related to the procedure, blood transfusion, and need for secondary procedures. Patients with an emergency department or provider visit leading to re-admission will be classified once in the primary outcome as re-admission.
Time Frame
4 weeks after surgery
Secondary Outcome Measure Information:
Title
Stone free status
Description
Stone free status will be defined as no residual stones with maximum diameter >3 mm on low dose non-contrast CT scan at 4 weeks post-surgery.
Time Frame
4 weeks after surgery
Title
Change in Wisconsin Stone Quality of Life Questionnaire by 10 points or more from baseline to 4 weeks after surgery.
Description
The Wisconsin Stone Quality of Life Questionnaire is a validated, disease specific quality-of-life instrument that has been used in the acute, chronic, and post-operative setting and is currently the most commonly used questionnaire for kidney stone disease.The survey is a 28-item instrument with a 5-point Likert scale for each item. There is a total of 140 points, and a difference of 10 points is considered clinically significant.
Time Frame
This will be completed at the initial visit (baseline) and at the follow-up visit 4 weeks later.
Title
Cumulative opiate morphine equivalent dosing
Description
This will be the calculated as the morphine equivalent dosage of all opioid medications taken by patients from time of surgery to follow-up at 4 weeks above their baseline opioid needs.
Time Frame
4 weeks after surgery
Title
Return to work
Description
Mean time to return to work (in days) and percent who have returned to work at 1 week will be determined at the time of the 4-week follow-up visit.
Time Frame
4 weeks after surgery
Title
Time in hospital
Description
Duration spent in hospital (in hours) will be determined
Time Frame
1 week after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gregory W. Hosier, MD, MSc
Phone
(613) 545-1970
Email
greg.hosier@kingstonhsc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Arevalo
Email
catherine.arevalo@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Chi, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Ambulatory Versus Inpatient Percutaneous Nephrolithotomy
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