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

December 7, 2024 updated by: Mehmet Fatih Şahin, Namik Kemal University
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Tekirdağ, Turkey, 59020
        • Recruiting
        • Tekirdag Namık Kemal University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?
within 2 weeks after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Namik Kemal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 4, 2024

First Submitted That Met QC Criteria

December 4, 2024

First Posted (Actual)

December 9, 2024

Study Record Updates

Last Update Posted (Estimated)

December 12, 2024

Last Update Submitted That Met QC Criteria

December 7, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024.304.11.11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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