The Effect of Preoperative Culture Timing on Postoperative Outcomes of Retrograde Intrarenal Surgery

NCT06723327 | Recruiting

• 1 other identifier: 2024.304.11.11
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The rate of complications (unexpected situations) after retrograde intrarenal surgery is reported to be 9-25%, and the majority of these are postoperative infections. Surgery must be performed under sterile (microbial-free) urine culture to prevent these complications. There are guideline recommendations regarding sterile urine culture reporting, but it is not clear how long in advance it should be taken. The possibility of the patient becoming infectious again during the period leading up to surgery is a condition that needs to be determined. Therefore, the culture taken before surgery should be compared with the urine culture result taken at the latest possible time before the operation.

Conditions

Urinary Infections; Urolithiasis

Keywords

urine culture; urolithiasis; kidney stone; retrograde intrarenal surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative infection rates

  Is there a difference in postoperative infectious complications between patients with two sterile preoperative urine cultures and patients with sterile cultures 2 weeks before the operation but positive urine cultures taken on the morning of the operation?

  within 2 weeks after the surgery

Study Arms (2)

Patients with 2 sterile urine cultures

Before retrograde intrarenal surgery, patients with sterile urine culture 2 weeks before the surgery and morning urine culture

Patients with only one sterile urine culture

Before retrograde intrarenal surgery, patients having sterile urine culture 2 weeks before the surgery and positive morning urine culture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A cohort of 950 patients with two negative preoperative urine cultures and patients with 50 positive urine cultures on the operation morning.

You may qualify if:

• Patients over 18 years of age
• Patients who had a urine culture taken 2 weeks before the operation and reported as sterile

You may not qualify if:

• Patients under 18 years of age
• Patients without sufficient data
• Patients with a urine culture more than 2 weeks before retrograde intrarenal -surgery
• Patients with a positive urine culture before retrograde intrarenal surgery
• Patients with renal anatomic anomalies
• Patients with a solitary (single) kidney

Sponsors & Collaborators

• Namik Kemal University: lead

Study Sites (1)

Tekirdag Namık Kemal University

Tekirdağ, 59020, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Mekayten M, Heifetz EM, Sompolinsky Y, Lorber A, Duvdevani M, Strahilevitz J. Timing of midstream urine culture before endourological procedure-can we do better?-A comparative study. Urolithiasis. 2023 Aug 27;51(1):110. doi: 10.1007/s00240-023-01483-x.

  PMID: 37634153 BACKGROUND

• Akkas F, Cinislioglu N, Haciislamoglu A, Atar FA, Guner E, Karadag S. Does time elapsed between urine culture and retrograde intrarenal surgery affect the rate of systemic inflammatory response syndrome? Actas Urol Esp (Engl Ed). 2022 May;46(4):223-229. doi: 10.1016/j.acuroe.2022.02.003. Epub 2022 Feb 21. English, Spanish.

  PMID: 35210199 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine culture

MeSH Terms

Conditions

Urolithiasis; Kidney Calculi

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mehmet F. Şahin, Assistant Professor

CONTACT

05555511871; mfatihsahin@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: December 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)