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The Investigators objective is to compare the clinical efficacy of a single-day protocol with a short-course protocol for PCNL. The investigator hope is to reduce the use of possibly unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further propagation of resistant microbes.
For large renal stone burdens and/or complex stones, Percutaneous Nephrolithotomy (PCNL) has become the mainstay for treatment, replacing open kidney stone surgery since it's introduction in 1976. However, PCNL is not without its complications, specifically infectious. The procedure carries up to 25% incidence of infectious complications with approximately 1% rate of severe sepsis even with completely sterile conditions. Therefore, the use of antibiotics becomes paramount, but to date there are no PNCL specific guidelines for the appropriate duration and class of antibiotics. This fact leaves the practicing urologists to their own subjective experiences to the guide them. In addition, in an age where there are increasing numbers of resistant microbes the judicious use of antibiotics is in even more paramount.
The investigators of this project, purpose a randomized intention to treat prospective study to explore the duration and type of antibiotics in a larger population then previously studied. The investigators hypothesize that there will be no difference in complications between two groups: 1) 24 hours of perioperative antibiotics versus 2) Continued antibiotics until the removal of any external catheters. The investigators will model the antibiotics choices and duration after the 2013 American Urological Association, (AUA) Urologic Surgery Antimicrobial Prophylaxis recommendations, modified by our local antibiogram as necessary. The investigators' objective is to compare the clinical efficacy of a single-day protocol with a short-course protocol for PCNL. Our hope is to reduce the use of possibly unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further propagation of resistant microbes.
Antibiotic detail: cephalosporins or aminoglycoside + metronidazole or clindamycin and the alternative for allergies being aminoglycoside/ sulbactam or fluoroquinolone
Looking at the same drugs and doses the variable is the timeframe of the medication
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotics for a 24 hour period | Active Comparator | Antibiotics for a 24 hour period Intervention drug to be determined based on patient history etc. |
|
| Continued antibiotics | Active Comparator | Continued antibiotics until the removal of any external catheters Intervention drug to be determined based on patient history etc. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cephalosporins | Drug | Patients were randomly assigned to the interventional arm or the control arm through stratified randomization. In addition to perioperative antibiotics, those in the interventional arm only received antibiotic course for up to 24 hours after procedure, while those in the control arm received antibiotics until external catheters were removed based on surgeon preference. Ancef, a 1st generation cephalosporin, was used as the primary antibiotic, which was started within 60 minutes of the procedure. Dosing was 1 gram IV every 8 hours and was adjusted for renal dosing as needed |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Infectious Complications | Compare the rate of infectious complications following a single-dose of peri-operative protocol (antibiotics for 24 hours as recommended by the American Urological Association Guidelines) with a short-course protocol (antibiotics continued until any external catheters such as nephrostomy tubes are removed) following percutaneous nephrolithotomy. Complication rate differences, primarily infectious complications such as fever, sepsis, systemic inflammatory response. | 0-30 days post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay (Days) | Length of Hospital Stay After Surgery (days) | 0-30 days post operatively |
| Number of Participants With Associated Clavien Grade of Adverse Event | Overall complication rates are reported based on Clavien-Dindo scale. The numbers reported are recorded Clavien complications. There is only one Clavien complication per patient as such a recorded number indicates one complication of this classification and also one patient with this complication. For example, if a Clavien III is recorded, it is indicating that one patient in that study group had one Clavien III complication. Grade I are any deviation from the normal post-operative course not requiring surgical, endoscopic or radiological intervention. Grade II complications require drug treatments other than those allowed for Grade I complications; Grade III complications require surgical, endoscopic or radiological intervention either IIIa, not under general anesthesia or IIIb, under general anesthesia. Grade IV are Life-threatening complications. Grade V are most severe and result in death of the patient. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zeph Okeke, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore University Hospital | Manhasset | New York | 11030 | United States | ||
| Long Island Jewish Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37578113 | Derived | Griffiths L, Aro T, Samson P, Derisavifard S, Gaines J, Alaiev D, Mullen G, Rai A, Williams T, Patel V, Guanay G, Leavitt D, Hartman C, Smith A, Hoenig D, Okeke Z. Prospective Randomized Trial of Antibiotic Prophylaxis Duration for Percutaneous Nephrolithotomy in Low-Risk Patients. J Endourol. 2023 Oct;37(10):1075-1080. doi: 10.1089/end.2022.0678. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Antibiotics for a 24 Hour Period | Antibiotics for a 24 hour period Intervention drug to be determined based on patient history etc. cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication aminoglycoside metronidazole Clindamycin aminoglycoside/ sulbactam: If allergies to above medicines Fluoroquinolones |
| FG001 | Continued Antibiotics | Continued antibiotics until the removal of any external catheters Intervention drug to be determined based on patient history etc. cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication aminoglycoside metronidazole Clindamycin aminoglycoside/ sulbactam: If allergies to above medicines Fluoroquinolones |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients were randomly assigned to the interventional arm or the control arm through stratified randomization. In addition to perioperative antibiotics, those in the interventional arm only received antibiotic course for up to 24 hours after procedure, while those in the control arm received antibiotics until external catheters were removed based on surgeon preference.
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| ID | Title | Description |
|---|---|---|
| BG000 | Antibiotics for a 24 Hour Period | Antibiotics for a 24 hour period Intervention drug to be determined based on patient history etc. cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication aminoglycoside metronidazole Clindamycin aminoglycoside/ sulbactam: If allergies to above medicines Fluoroquinolones |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Infectious Complications | Compare the rate of infectious complications following a single-dose of peri-operative protocol (antibiotics for 24 hours as recommended by the American Urological Association Guidelines) with a short-course protocol (antibiotics continued until any external catheters such as nephrostomy tubes are removed) following percutaneous nephrolithotomy. Complication rate differences, primarily infectious complications such as fever, sepsis, systemic inflammatory response. | Patients were randomly assigned to the interventional arm or the control arm through stratified randomization. In addition to perioperative antibiotics, those in the interventional arm only received antibiotic course for up to 24 hours after procedure while those in the control arm received antibiotics until external catheters were removed based on surgeon preference | Posted | Count of Participants | Participants | 0-30 days post-operatively |
|
All adverse events occurring within the first 30 post-operative days were recorded for each patient.
The primary outcome was the rate of postoperative sepsis further stratified by presence of body temperature >38 degrees Celsius, positive SIRS criteria, bacteremia, or bacteriuria. Adverse events are graded according to Clavien dindo scale, I-V with increasing severity up to V, which is patient death. Serious adverse events are defined by Clavien IIIb or higher, which is defined as requiring an additional procedure with general anesthesia.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Antibiotics for a 24 Hour Period | Antibiotics for a 24 hour period Intervention drug to be determined based on patient history etc. cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication aminoglycoside metronidazole Clindamycin aminoglycoside/ sulbactam: If allergies to above medicines Fluoroquinolones |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemothorax/Pneumothorax | Surgical and medical procedures | Clavien-Dindo | Systematic Assessment | Puncture of diaphragm during procedure leading to blood or air filling pleural space. This requires patient to have a chest tube placement. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fevers post operative | Blood and lymphatic system disorders | Clavien-Dindo II | Systematic Assessment | readmitted for fevers requiring additional antibiotic treatment. |
Procedure included tubeless procedures. While this may aid in generalizability, an element of antibiotic duration variation is unavoidably introduced in this treatment arm. The original design was to have 290 participants, due to the low number of recruitment, this number was reduced to a goal of 100 total with 50 randomized to each arm. This limits the analysis, but ultimately desired measures were achieved.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Zeph Okeke | Northwell Health | 516-734-8500 | zokeke@northwell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 18, 2016 | Jan 29, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D002437 | Cefazolin |
| D024841 | Fluoroquinolones |
| D002939 | Ciprofloxacin |
| D002981 | Clindamycin |
| D055231 | Lincosamides |
| D000667 | Ampicillin |
| D005839 | Gentamicins |
| ID | Term |
|---|---|
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 |
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|
|
| Fluoroquinolones | Drug | If the patient has an allergy to penicillin or cephalosporin, then Ciprofloxacin was used instead and started within 120 minutes of the procedure at 400mg IV and would be continued every 12hrs if patient has a normal creatinine clearance |
|
|
| Clindamycin | Drug | If allergic to penicillin, cephalosporins, and fluoroquinolones, 900 mg Clindamycin started within 60 minutes prior to initial surgical incision. |
|
|
| Ampicillin/Gentamicin | Drug | 5 mg/kg as a single dose of Gentamicin within 60 minutes prior to surgical incision; given in combination with 2 grams of ampicillin in cases where allergic to fluoroquinolone and cephalosporin |
|
|
| 0 to 30 days after surgery |
| New Hyde Park |
| New York |
| 11040 |
| United States |
| BG001 |
| Continued Antibiotics |
Continued antibiotics until the removal of any external catheters Intervention drug to be determined based on patient history etc. cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication aminoglycoside metronidazole Clindamycin aminoglycoside/ sulbactam: If allergies to above medicines Fluoroquinolones |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Antibiotics for a 24 hour period Intervention drug to be determined based on patient history etc. cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication aminoglycoside metronidazole Clindamycin aminoglycoside/ sulbactam: If allergies to above medicines Fluoroquinolones |
| OG001 | Continued Antibiotics | Continued antibiotics until the removal of any external catheters Intervention drug to be determined based on patient history etc. cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication aminoglycoside metronidazole Clindamycin aminoglycoside/ sulbactam: If allergies to above medicines Fluoroquinolones |
|
|
| Secondary | Length of Stay (Days) | Length of Hospital Stay After Surgery (days) | Posted | Mean | Standard Deviation | Days | 0-30 days post operatively |
|
|
|
| Secondary | Number of Participants With Associated Clavien Grade of Adverse Event | Overall complication rates are reported based on Clavien-Dindo scale. The numbers reported are recorded Clavien complications. There is only one Clavien complication per patient as such a recorded number indicates one complication of this classification and also one patient with this complication. For example, if a Clavien III is recorded, it is indicating that one patient in that study group had one Clavien III complication. Grade I are any deviation from the normal post-operative course not requiring surgical, endoscopic or radiological intervention. Grade II complications require drug treatments other than those allowed for Grade I complications; Grade III complications require surgical, endoscopic or radiological intervention either IIIa, not under general anesthesia or IIIb, under general anesthesia. Grade IV are Life-threatening complications. Grade V are most severe and result in death of the patient. | Posted | Count of Participants | Participants | 0 to 30 days after surgery |
|
|
|
| 0 |
| 49 |
| 1 |
| 49 |
| 9 |
| 49 |
| EG001 | Continued Antibiotics | Continued antibiotics until the removal of any external catheters Intervention drug to be determined based on patient history etc. cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication aminoglycoside metronidazole Clindamycin aminoglycoside/ sulbactam: If allergies to above medicines Fluoroquinolones | 0 | 49 | 2 | 49 | 10 | 49 |
|
| Fevers with Hydronephrosis | Renal and urinary disorders | Clavien-Dindo | Systematic Assessment | Post surgical fever with associated hydronephrosis indicates blockage of upper tracts requiring drainage with ureteral stent |
|
|
| Post operative urinary retention | Renal and urinary disorders | Clavien-Dindo I | Systematic Assessment | Urinary retention requiring foley catheter placement |
|
| Post operative pain | General disorders | Clavien-Dindo I | Systematic Assessment | return to emergency room for post operative flank pain, resolved with conservative management. |
|
| Post operative anemia requiring transfusion | Surgical and medical procedures | Clavien-Dindo I | Systematic Assessment | Post operative bleeding requiring transfusion |
|
| Post-operative embolization | Surgical and medical procedures | Clavien-Dindo IIIa | Systematic Assessment | post operative delayed bleeding requiring embolization |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D008034 | Lincomycin |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D000617 | Aminoglycosides |
| Grade IIIA |
|
| Grade IIIB |
|