Preoperative Edema is a Significant Risk Factor for Post-hepatectomy Complications

August 12, 2024 updated by: Takehiro Okabayashi, Kochi University

Preoperative Edema is a Significant Risk Factor for Post-hepatectomy Complications Regardless of the Underlying Disease.

Aims: The relationship between bioelectrical impedance analysis (BIA) results and post-hepatectomy complications is unknown. This study aimed to identify the risk factors for post-hepatectomy complications from the BIA results.

Methods: This prospective, observational cohort study reviewed the data of patients who underwent hepatectomy between March 2018 and December 2022. The patients were matched using the following propensity score covariates: biliary enteric anastomosis and major hepatectomy. Risk factors for postoperative complications were investigated in a matched cohort.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

414

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

  • Japan
      • Kochi, Japan, 781-8555
        • Takehiro Okabayashi

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

We prospectively reviewed consecutive patients who underwent hepatectomy at the Kochi Health Sciences Center. Patients who underwent hepatectomy, regardless of the underlying disease, between March 2018 and December 2022 were eligible for the study. Patients who did not undergo preoperative BIA were excluded. Those who underwent repeat hepatectomies were included; however, if they underwent more than two hepatectomies in the study period, only the clinical features during the first hepatectomy period were included and those during the second or third hepatectomy period were excluded.

Description

Inclusion Criteria:

  • clinical diagnosis of liver neoplasms

Exclusion Criteria:

  • a body weight loss of >10% during the 6 months before surgery; the presence of distant metastases; or seriously impaired function of vital organs because of respiratory, renal, or heart disease

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
incidence of post-hepatectomy complications
Time Frame: incidence of post-hepatectomy complications
through study completion, 1year
incidence of post-hepatectomy complications

Collaborators and Investigators

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

Sponsor

Kochi University

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, 2023

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

August 6, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 12, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KHSC2401

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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