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

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04750031
• Other study ID #: KouGasLVBx01
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: March 1, 2021

Study information

• Verified date: February 2021
• Source: Kocaeli University
• Contact: Hasan Yilmaz
• Phone: +905058774821
• Email: gyrusus[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Cronic hepatitis B Infection

2. Chronic hepatitis C Infection

3. NASH

4. DILI

5. Acute or chronic liver damage caused unknown aetiology

Exclusion Criteria:

1.Refuse to give written informed consent

Related Conditions & MeSH terms

• Acute Pain
• Liver Diseases
• Pain, Acute

Intervention

Procedure:
• Liver Biopsy
Liver biopsy is a procedure to obtain small amount of liver by a needle.

Locations

Country	Name	City	State
Turkey	Kocaeli University Medical Faculty Hospital	Izmit	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Costa RS, Cardoso AF, Ferreira A, Costa J, Costa D, Fernandes D, Caetano AC. What recovery position should patients adopt after percutaneous liver biopsy? Eur J Gastroenterol Hepatol. 2019 Feb;31(2):253-259. doi: 10.1097/MEG.0000000000001290. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores	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	Complications	Complications such as liver lickage ,bleeding, infection at biopsy site will be recorded	within 2 weeks after the procedure