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NCT Number: NCT06723327

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tekirdag Namık Kemal University

Tekirdağ, 59020, Turkey (Türkiye)

Location status: Recruiting

Location contact

Mehmet Fatih Şahin

CONTACT

[email protected]

05555511871

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Postoperative infection rates

    Time frame: within 2 weeks after the surgery

    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?

Study contacts

Contact information is provided by the study sponsor or research team.

Mehmet F. Şahin, Assistant Professor

CONTACT

[email protected]

05555511871

Sponsors and collaborators

Lead sponsor

Namik Kemal University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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