Ambulatory Versus Inpatient Percutaneous Nephrolithotomy

NCT04690010 | Unknown

• 1 other identifier: 20-33137
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Calculi

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks after surgery

Secondary Outcomes (5)

• Stone free status

  4 weeks after surgery

• Change in Wisconsin Stone Quality of Life Questionnaire by 10 points or more from baseline to 4 weeks after surgery.

  This will be completed at the initial visit (baseline) and at the follow-up visit 4 weeks later.

• Cumulative opiate morphine equivalent dosing

  4 weeks after surgery

• Return to work

  4 weeks after surgery

• Time in hospital

  1 week after surgery

Study Arms (2)

Ambulatory tubeless PCNL

ACTIVE COMPARATOR

Patients will be discharged home on the same day as surgery. No nephrostomy tube will be placed (tubeless).

Procedure: Ambulatory tubeless PCNL

Inpatient PCNL with nephrostomy tube

ACTIVE COMPARATOR

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.

Procedure: Inpatient PCNL with nephrostomy tube

Interventions

Ambulatory tubeless PCNL PROCEDURE

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.

Ambulatory tubeless PCNL

Inpatient PCNL with nephrostomy tube PROCEDURE

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.

Inpatient PCNL with nephrostomy tube

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Queen's University: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Chi, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: December 30, 2020
• Study Start: January 8, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)