Pain Scores and Complications do Not Differ at Three Recovery Position After Liver Biopsy

February 12, 2021 updated by: Hasan Yılmaz, Kocaeli University

Evaluation of the Pain and Post Procedural Complications of Liver Biopsy Among Different Recovery Positions

Liver biopsy is still used as the gold standard in the diagnosis of many liver diseases. During the observation after liver biopsy, patients are hospitalized on their right side, which is the biopsy side, with the thought that adverse events (complications) such as bleeding or bile leakage will be less. Patients who do not develop complications after 4-6 hours of observation are discharged home. Some of the patients state that the right side-lying position for 4-6 hours is uncomfortable than the biopsy itself, and they prefer to lie on their back. In our study, researchers aim to investigate the rate of complications after biopsy, what recovery position found more acceptable by the patients.

Study Overview

Status

Unknown

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

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kocaeli
      • Izmit, Kocaeli, Turkey, 41001
        • Recruiting
        • Kocaeli University Medical Faculty Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Acute and chronic liver damaged patients

Description

Inclusion Criteria:

  1. Cronic hepatitis B İnfection
  2. Chronic hepatitis C İnfection
  3. NASH
  4. DILI
  5. Acute or chronic liver damage caused unknown aetiology

Exclusion Criteria:

1.Refuse to give written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ANTICIPATED)

March 1, 2021

Study Completion (ANTICIPATED)

March 1, 2021

Study Registration Dates

First Submitted

February 6, 2021

First Submitted That Met QC Criteria

February 6, 2021

First Posted (ACTUAL)

February 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 12, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • KouGasLVBx01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymised pain scores and descriptive data

IPD Sharing Time Frame

Data will be shared 3 months after the last patient recruited and it will be available 1 year.

IPD Sharing Access Criteria

publicly aviable

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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