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

NCT ID: NCT06723327

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-12-31

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.

Detailed Description

Retrograde Intrarenal Surgery (RIRC) (a surgery to fragment stones inside the kidney by entering from the distal end of the urinary tract with a camera system and light optical imaging device) is increasingly used today thanks to the developments in laser and scope (imaging device) technology. The risk of complications (unexpected situations) after this surgery is reported as 9-25%, most of which are infections. These infections can be severe conditions that can lead to septic shock (system failure due to severe infection) and death, as well as fever requiring only antipyretics (fever reducers).

Preventing infectious complications is as important as ensuring stone-free status for this surgery. For this purpose, surgery must be performed under sterile (microbe-free) urine culture. Patients with positive urine cultures should be taken to surgery due to increased pressure on the kidney, which can cause reflux (backflow of the kidney into the bloodstream) and infectious urine entering the circulation, leading to septicemia (microbes mixing into the bloodstream).

There are guideline recommendations regarding sterile urine culture reporting, but it is not clear how long in advance it should be taken. In the American Urology guidelines, a sterile urine culture within 1 month is sufficient to be taken to surgery, but no period is specified in the European Urology guidelines. The possibility of the patient becoming infected 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 period before the operation. This study aims to evaluate the preoperative and morning urine culture results and compare the postoperative results of patients with this difference.

Conditions

Urinary Infections; Urolithiasis

Keywords

urine culture; urolithiasis; kidney stone; retrograde intrarenal surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with 2 sterile urine cultures

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Namik Kemal University

OTHER

Sponsor Role: lead

Responsible Party

Mehmet Fatih Şahin

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tekirdag Namık Kemal University

Tekirdağ, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Mehmet F. Şahin, Assistant Professor

Role: CONTACT

Phone: 05555511871

Email: mfatihsahin@gmail.com

Facility Contacts

Mehmet Fatih Şahin

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 37634153 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35210199 (View on PubMed)

Other Identifiers

2024.304.11.11

Identifier Type: -

Identifier Source: org_study_id