Antibiotic Prophylaxis When Removing Ureteric Stent After Stone Surgery

Ureteric Stent After Stone Surgery Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01768364
• Other study ID #: 2012/953
• Status: Not yet recruiting
• Phase: N/A
• First received: January 14, 2013
• Last updated: January 14, 2013
• Start date: January 2013
• Est. completion date: April 2016

Study information

• Verified date: January 2013
• Source: University Hospital, Akershus
• Contact: Tor Erik Sand, MD, PhD
• Email: tor.erik.sand[@]ahus.no
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Is there anything to gain in giving antibiotics as prophylaxis when removing ureteric stents cystoscopically after stone surgery?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: April 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ureteric Stent After Stone Surgery

Intervention

Drug:
• Trimetoprim-Sulfa (Bactrim)

Other:
• No antibiotics

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lorenskog

Sponsors (1)

Lead Sponsor	Collaborator
Tor Erik Sand

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	14 days infection rate w/wo antibiotics		14 days	No
Secondary	infection rate with ureter stent wo antibiotics		14 days	No