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

NCT06555510 | Completed

• 1 other identifier: KHSC2401
• Study Type: observational
• Target: 414
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patients Who Underwent Hepatectomy for Liver Neoplasms

Outcome Measures

Primary Outcomes (1)

• incidence of post-hepatectomy complications

  through study completion, 1year

  incidence of post-hepatectomy complications

Interventions

InBody OTHER

Bioelectrical impedance analysis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• clinical diagnosis of liver neoplasms

You may not qualify if:

• 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

Sponsors & Collaborators

• Kochi University: lead

Study Sites (1)

Takehiro Okabayashi

Kochi, 781-8555, Japan

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gastroenterological Surgery

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 15, 2024
• Study Start: January 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

JP (1)