Antibiotic Prophylaxis When Removing Ureteric Stent After Stone Surgery

NCT ID: NCT01768364

Last Updated: 2013-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Ureteric Stent After Stone Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Antibiotics

will receive antibiotics

Group Type ACTIVE_COMPARATOR

Trimetoprim-Sulfa (Bactrim)

Intervention Type DRUG

No antibiotics

will not receive antibiotics

Group Type ACTIVE_COMPARATOR

No antibiotics

Intervention Type OTHER

Interventions

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Trimetoprim-Sulfa (Bactrim)

Intervention Type DRUG

No antibiotics

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* ongoing antibiotic treatment, allergy to trimetoprim-sulfa
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tor Erik Sand

OTHER

Sponsor Role lead

Responsible Party

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Tor Erik Sand

Professor, M.D., Ph.D.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tor Erik Sand, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Akershus

Locations

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Akershus University Hospital

Lorenskog, Lorenskog, Norway

Site Status

Countries

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Norway

Central Contacts

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Tor Erik Sand, MD, PhD

Role: CONTACT

Manuela Estop-Garanto, MD

Role: CONTACT

Facility Contacts

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Manuela Estop-Garanto, MD

Role: primary

Tor Erik Sand, MD, PhD

Role: backup

Other Identifiers

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2012/953

Identifier Type: -

Identifier Source: org_study_id

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