- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04750031
Pain Scores and Complications do Not Differ at Three Recovery Position After Liver Biopsy
Evaluation of the Pain and Post Procedural Complications of Liver Biopsy Among Different Recovery Positions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Liver biopsy is still used as the gold standard in the diagnosis of many liver diseases. The health practice notification (SUT) makes the diagnosis with liver biopsy mandatory for the treatment of chronic viral hepatitis (Chronic Hepatitis B Inf. And Chronic Hepatitis C Inf.). In daily gastroenterology practice, clinicians frequently perform a liver biopsy for the diagnosis of non-alcoholic fatty liver (NASH), and to a lesser extent, for the diagnosis of Wilson Disease and Hemochromatosis.
During the observation after liver biopsy, patients are hospitalized on their right side, which is the biopsy side, with the argument that there will be less bleeding or bile leakage complications. Patients who do not develop complications after 4-6 hours of observation are discharged to their homes. (1) In this study, researchers aimed to investigate the post-biopsy position of patients who were referred to the clinic for liver biopsy, the rate of complications after biopsy, and to what extent the patients found the procedure acceptable according to their post-biopsy position.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Kocaeli
-
Izmit, Kocaeli, Turkey, 41001
- Recruiting
- Kocaeli University Medical Faculty Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Cronic hepatitis B İnfection
- Chronic hepatitis C İnfection
- NASH
- DILI
- Acute or chronic liver damage caused unknown aetiology
Exclusion Criteria:
1.Refuse to give written informed consent
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain scores
Time Frame: Immediately after the procedure
|
Patient reported pain scores will be assesed by visual analog scale, minimum score "0" refers no pain and "10" refers worst pain
|
Immediately after the procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complications
Time Frame: within 2 weeks after the procedure
|
Complications such as liver lickage ,bleeding, infection at biopsy site will be recorded
|
within 2 weeks after the procedure
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KouGasLVBx01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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