Antibiotic Prophylaxis When Removing Ureteric Stent After Stone Surgery

January 14, 2013 updated by: Tor Erik Sand
Is there anything to gain in giving antibiotics as prophylaxis when removing ureteric stents cystoscopically after stone surgery?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Many patients undergoing stone surgery receive a ureteric stent that should be removed after 14 days. This stent is removed cystoscopically and today this is done without giving antibiotics. Some patients get urinary tract infections subject to this. However the investigators do not know how many of these patients get UTI as most are followed by their primary care doctor. With this study the investigators would like to find out whether it is possible to avoid such infections and also find out how many actually do get infected.

Study Type

Interventional

Enrollment (Anticipated)

124

Phase

  • Not Applicable

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 Contact Backup

Study Locations

  • Norway
      • Lorenskog, Norway, 1478
        • Akershus University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tor Erik Sand, MD, PhD

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • stone surgery patients with ureteric stent that should be removed after 14 days

Exclusion Criteria:

  • ongoing antibiotic treatment, allergy to trimetoprim-sulfa

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Antibiotics
will receive antibiotics
Drug: Trimetoprim-Sulfa (Bactrim)
Active Comparator: No antibiotics
will not receive antibiotics
Other: No antibiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
14 days infection rate w/wo antibiotics
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
infection rate with ureter stent wo antibiotics
Time Frame: 14 days
14 days

Collaborators and Investigators

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

Sponsor

Tor Erik Sand

Investigators

  • Principal Investigator: Tor Erik Sand, MD. PhD, University Hospital, Akershus

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

January 1, 2013

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

January 14, 2013

First Submitted That Met QC Criteria

January 14, 2013

First Posted (Estimate)

January 15, 2013

Study Record Updates

Last Update Posted (Estimate)

January 15, 2013

Last Update Submitted That Met QC Criteria

January 14, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/953

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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