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

Sponsor
Kocaeli University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04750031
Collaborator
(none)
100
1
37.9
2.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Liver Biopsy

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Evaluation of the Pain and Post Procedural Complications of Liver Biopsy Among Different Recovery Positions
Actual Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Mar 1, 2021
Anticipated Study Completion Date :
Mar 1, 2021

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Complications [within 2 weeks after the procedure]

    Complications such as liver lickage ,bleeding, infection at biopsy site will be recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kocaeli University Medical Faculty Hospital Izmit Kocaeli Turkey 41001

Sponsors and Collaborators

  • Kocaeli University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hasan Yılmaz, Assistant Professor, Kocaeli University
ClinicalTrials.gov Identifier:
NCT04750031
Other Study ID Numbers:
  • KouGasLVBx01
First Posted:
Feb 11, 2021
Last Update Posted:
Feb 16, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2021