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Retrograde Intrarenal Surgery Low Risk Trial

NCT ID: NCT06741917

Last Updated: 2024-12-19

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

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-04

Study Completion Date

2026-06-30

Brief Summary

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In the treatment of kidney stones and upper ureteral stones, flexible ureteroscopic lithotripsy has become the mainstream choice due to its minimally invasive nature and high safety. However, there is still no universal consensus on the use of prophylactic antibiotics before surgery. Taiwan, located in the subtropical region, is one of the areas in the world with a high incidence of urinary tract stones. Currently, there are no established guidelines for the use of prophylactic antibiotics before flexible ureteroscopic lithotripsy in Taiwan. This study aims to evaluate the differences between single-dose, different types of prophylactic antibiotics in generally healthy adult patients undergoing flexible ureteroscopic lithotripsy.

Detailed Description

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This study focuses on flexible ureteroscopic lithotripsy, a procedure commonly used to treat kidney stones and stones in the upper part of the ureter. This surgery is popular because it is minimally invasive and considered very safe. However, there is no clear agreement on whether or which antibiotics should be given to patients before the surgery to prevent infections.

Taiwan is one of the regions in the world with a high rate of urinary tract stones, and because of this, it is especially important to ensure that the best practices are followed to prevent infections during and after the surgery. Currently, there are no official guidelines in Taiwan on which antibiotics should be used before flexible ureteroscopic lithotripsy.

This study aims to compare different types of single-dose antibiotics given before the surgery to see if one is more effective than others in preventing infections. By looking at how different antibiotics perform, the study hopes to provide clearer guidance for doctors in choosing the best antibiotic treatment for patients, ultimately improving patient care and reducing the risk of infections after surgery.

Conditions

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Retrograde Intrarenal Surgery Renal Stones

Keywords

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retrograde intrarenal surgery Prophylactic antibiotics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Oral Levofloxacin

Group Type EXPERIMENTAL

Levofloxacin

Intervention Type DRUG

single dose of oral Levofloxacin (500mg/tab) before retrograde intrarenal surgery

Intravenous cefmetzole

Group Type ACTIVE_COMPARATOR

Cefmetazole (drug)

Intervention Type DRUG

single dose of intravenous Cefmetazole (1000 mg)before retrograde intrarenal surgery

Interventions

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Levofloxacin

single dose of oral Levofloxacin (500mg/tab) before retrograde intrarenal surgery

Intervention Type DRUG

Cefmetazole (drug)

single dose of intravenous Cefmetazole (1000 mg)before retrograde intrarenal surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Stone diameter \< 3 cm or stone area \< 900 mm2
* Preoperative(2 weeks) negative urine culture
* No active symptoms , including fever, dysuria, urinary frequency, urgency)
* Urinalysis WBC \< 10/HPF

Exclusion Criteria

* Immunocompromised
* Poor control Diabetes mellitus
* Allergy to antibiotics
* Ureteric stents or Foley catheter present
* Ureteric stricture
* Renal or urethral deformity
* Antibiotic treatment for urinary tract infection in the preceding 4 weeks
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Wollin DA, Joyce AD, Gupta M, Wong MYC, Laguna P, Gravas S, Gutierrez J, Cormio L, Wang K, Preminger GM. Antibiotic use and the prevention and management of infectious complications in stone disease. World J Urol. 2017 Sep;35(9):1369-1379. doi: 10.1007/s00345-017-2005-9. Epub 2017 Feb 3.

Reference Type BACKGROUND
PMID: 28160088 (View on PubMed)

Other Identifiers

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202405150MIND

Identifier Type: -

Identifier Source: org_study_id