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Status unknownNCT04750031Updated Feb 16, 2021

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

An observational study in Pain, Acute and Liver Diseases, sponsored by Kocaeli University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-16.

Sponsored by Kocaeli University · Observational

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Pain, Acute
  • Liver Diseases

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In context

Liver Diseases

2,083 studies on the registry are indexed under Liver Diseases; 392 are open to participants now.

This study's planned enrollment of 100 is below the median of 167 across 683 observational studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Kocaeli University is the lead sponsor of 210 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Acute and chronic liver damaged patients

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

Exclusion Criteria:

1.Refuse to give written informed consent

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • ProcedureLiver Biopsy

    Liver biopsy is a procedure to obtain small amount of liver by a needle.

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What researchers measure

Primary outcomes

  1. Pain scores

    Patient reported pain scores will be assesed by visual analog scale, minimum score "0" refers no pain and "10" refers worst pain

    Time frame: Immediately after the procedure

Secondary outcomes

  1. Complications

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

    Time frame: within 2 weeks after the procedure

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Study locations

1 of 1 sites recruiting
  • Kocaeli University Medical Faculty Hospital
    Izmit, Kocaeli 41001, Turkey
    Recruiting
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References and documents

Publications

  • 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. PubMed 30358572 ↗

Individual participant data

Plan to share: Yes — Anonymised pain scores and descriptive data

Supporting information: Csr, Analytic code

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04750031
Lead sponsor
Kocaeli University
Responsible party
Hasan Yılmaz (Assistant Professor, Kocaeli University) — Principal investigator
First posted
Feb 11, 2021
Start date
Jan 1, 2018
Primary completion
Mar 1, 2021 (estimated)
Completion
Mar 1, 2021 (estimated)
Last update
Feb 16, 2021

Study contacts

Hasan Yılmaz
Contact
gyrusus@yahoo.com
+905058774821
Ali Erkan Duman
Contact
dralierkanduman@hotmail.com
+905335640607

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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