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Ambulatory Versus Inpatient Percutaneous Nephrolithotomy

NCT ID: NCT04690010

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-08

Study Completion Date

2024-12-30

Brief Summary

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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

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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.

Conditions

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Kidney Calculi

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ambulatory tubeless PCNL

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

Group Type ACTIVE_COMPARATOR

Ambulatory tubeless PCNL

Intervention Type 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.

Inpatient PCNL with nephrostomy tube

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.

Group Type ACTIVE_COMPARATOR

Inpatient PCNL with nephrostomy tube

Intervention Type 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.

Interventions

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Ambulatory tubeless PCNL

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

Inpatient PCNL with nephrostomy tube

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen's University

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Chi, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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20-33137

Identifier Type: -

Identifier Source: org_study_id