Pilot study to assess risk factors and complications in interventional ultrasound (INVUS)
- Conditions
- Interventionell Ultrasound
- Registration Number
- DRKS00025973
- Lead Sponsor
- Medizinische Hochschule Brandenburg Theodor FontaneBrandenburgisches Institut Klinischer Ultraschall (BIKUS)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
The study will include diagnostic and/or therapeutic interventions under continuous ultrasound imaging percutaneously or transcavitary (endosonographic) in the abdomen and/or retroperitoneum in patients aged eighteen years and older. Including simple punctures for fluid or tissue removal up to more complex drainage therapies as well as ablation and sclerotherapy procedures.
Exclusion Criteria
Diagnostic or therapeutic ascites punctures, procedures in the prostate region and outside the abdomen, e.g. on the thorax (including the mediastinum) or on the extremities and joints, should not be included. Lack of patient consent to participate in the study. Children and adolescents not completed 18 years of age.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The study objective is to test a web-based documentation system for the collection of routine data related to ultrasound-assisted procedures and to evaluate the selected collection parameters for analyzability with respect to the following endpoints:<br>1. frequency of immediate complications (e.g., bleeding) and late complications (especially infections), overall morbidity and mortality.<br>2. predictors of inadequate intervention outcomes and of complications <br>3. effectiveness of measures for complication prevention<br>4. frequency, range of methods and effectiveness of the use of INVUS for the treatment of abscesses.
- Secondary Outcome Measures
Name Time Method