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

• Conditions: Pain, Acute; Liver Diseases

• Registration Number: NCT04750031
• Lead Sponsor: Kocaeli University

Brief Summary

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.

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 Timeline

• Study Start: 2018-01-01
• Status Verified: 2021-02
• Study First Submitted: 2021-02-06
• Study First Submitted QC: 2021-02-06
• Study First Posted: 2021-02-11
• Last Update Submitted: 2021-02-12
• Last Update Posted: 2021-02-16
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain scores	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

Secondary Outcome Measures

Name	Time	Method
Complications	within 2 weeks after the procedure	Complications such as liver lickage ,bleeding, infection at biopsy site will be recorded

Trial Locations

Locations (1)

Kocaeli University Medical Faculty Hospital; 🇹🇷 Izmit, Kocaeli, Turkey