Patient-driven Compression in Urography

NCT ID: NCT02622269

Last Updated: 2016-02-25

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

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-01-31

Brief Summary

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Compression of the abdomen during urography with either a patient-regulated compression device or conventional compression.

Evaluation of radiation dose, image quality and patients' experiences

Detailed Description

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Patients are subjected to radiation from radiographical studies. The nurse can reduce the radiation dose for the individual by using dose-reducing measures. One of these is compression. It is known that compression in urography reduces the radiation dose because the radiation has less tissue to transverse when it is compressed. By reducing patient radiation doses, the risk of harmful radiation effects is reduced. This study aims to study if a patient-regulated compression device can reduce the radiation dose as effectively as the conventional compression, regulated by the nurse.

Two compression devices are investigated in each patient, in randomized order.

Aims of the study:

1. Evaluate if the radiation doses are comparable with a patient-regulated compression device and conventional compression.
2. Evaluate image quality with the two devices.
3. Describe patients' experiences from using the two devices.

Conditions

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Urologic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Patient-regulated compression

Patient-regulated compression device

Group Type EXPERIMENTAL

Patient-regulated compression device

Intervention Type DEVICE

Compression of the abdomen with a patient-regulated compression device

Standard compression

Standard compression device

Group Type ACTIVE_COMPARATOR

Standard compression device

Intervention Type DEVICE

Compression of the abdomen with the standard compression device

Interventions

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Patient-regulated compression device

Compression of the abdomen with a patient-regulated compression device

Intervention Type DEVICE

Standard compression device

Compression of the abdomen with the standard compression device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Outpatients with a request for a urographic study

Exclusion Criteria

* Emergency studies,
* cannot participate actively with compression,
* contraindications to compression of the abdomen,
* pregnancy,
* inability to understand the language of the questionnaire
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Örebro University, Sweden

OTHER

Sponsor Role lead

Responsible Party

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Håkan Geijer

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Håkan Geijer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Sweden

Locations

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Department of Radiology

Örebro, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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183781

Identifier Type: -

Identifier Source: org_study_id

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