- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07404527
Bioelectrical Impedance Analysis for Perioperative Fluid Evaluation in Colorectal Cancer Surgery
Usefulness of Bioelectrical Impedance Analysis for Perioperative Fluid Evaluation and Complication Prediction in Oncological Patients Undergoing Colorectal Surgery
This study evaluates the usefulness of bioelectrical impedance analysis (BIA) for perioperative fluid evaluation and prediction of postoperative complications in oncological patients undergoing colorectal surgery.
Bioelectrical impedance analysis is used to assess body fluid status and body composition before and after surgery. The study aims to determine whether perioperative BIA measurements may contribute to improved assessment of fluid balance and early identification of patients at increased risk of postoperative complications.
The study is conducted at the Institute of Oncology Ljubljana in patients undergoing colorectal surgery for oncological indications.
Study Overview
Status
Intervention / Treatment
Detailed Description
Accurate perioperative fluid assessment is important in patients undergoing colorectal surgery, as both fluid overload and inadequate fluid replacement may contribute to postoperative complications and delayed recovery.
Bioelectrical impedance analysis (BIA) is a non-invasive diagnostic method that enables assessment of body composition and fluid status. In this study, BIA measurements are performed in oncological patients undergoing colorectal surgery in order to evaluate perioperative changes in body fluid compartments and to assess whether these measurements may help predict postoperative complications.
The study evaluates the relationship between perioperative BIA parameters and clinical outcomes after colorectal surgery. The aim is to assess whether BIA may be useful as an additional diagnostic method for perioperative fluid evaluation and early identification of patients at increased risk of complications.
The study is conducted at the Institute of Oncology Ljubljana. According to the latest annual report, patient enrollment has been completed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ljubljana, Slovenia, 1000
- Institute of Oncology Ljubljana
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients aged 18 years or older.
- Patients with oncological disease undergoing colorectal surgery at the Institute of Oncology Ljubljana.
- Ability to undergo bioelectrical impedance analysis (BIA) measurements.
- Signed written informed consent.
Exclusion Criteria:
- Patients younger than 18 years.
- Patients unable to undergo BIA measurements.
- Patients with conditions that, in the investigator's opinion, make participation in the study unsuitable.
- Refusal to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Bioelectrical Impedance Analysis
Oncological patients undergoing colorectal surgery undergo perioperative bioelectrical impedance analysis (BIA) measurements to assess body fluid status and body composition.
BIA results are evaluated in relation to postoperative complications and perioperative clinical outcomes.
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Bioelectrical impedance analysis (BIA) is performed perioperatively to assess body fluid status and body composition.
BIA parameters are evaluated for their potential usefulness in perioperative fluid assessment and prediction of postoperative complications in oncological patients undergoing colorectal surgery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of Participants With Postoperative Complications Within 30 Days After Colorectal Surgery
Time Frame: Up to 30 days after colorectal surgery.
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Postoperative complications will be identified from routine clinical documentation after colorectal surgery.
The unit of measure will be the percentage of participants with at least one postoperative complication within 30 days after colorectal surgery.
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Up to 30 days after colorectal surgery.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Total Body Water Assessed by Bioelectrical Impedance Analysis
Time Frame: From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery.
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Total body water will be measured using bioelectrical impedance analysis before and after colorectal surgery.
The unit of measure will be liters.
The outcome will be reported as the change from preoperative baseline in total body water.
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From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery.
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Change From Baseline in Extracellular Water Assessed by Bioelectrical Impedance Analysis
Time Frame: From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery.
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Extracellular water will be measured using bioelectrical impedance analysis before and after colorectal surgery.
The unit of measure will be liters.
The outcome will be reported as the change from preoperative baseline in extracellular water.
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From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery.
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Change From Baseline in Intracellular Water Assessed by Bioelectrical Impedance Analysis
Time Frame: From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery.
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Intracellular water will be measured using bioelectrical impedance analysis before and after colorectal surgery.
The unit of measure will be liters.
The outcome will be reported as the change from preoperative baseline in intracellular water.
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From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery.
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Change From Baseline in Extracellular Water to Total Body Water Ratio Assessed by Bioelectrical Impedance Analysis
Time Frame: From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery.
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The extracellular water to total body water ratio will be calculated from bioelectrical impedance analysis measurements obtained before and after colorectal surgery.
The outcome will be reported as the change from preoperative baseline in the extracellular water to total body water ratio.
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From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery.
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Change From Baseline in Fat-Free Mass Assessed by Bioelectrical Impedance Analysis
Time Frame: From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery.
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Fat-free mass will be measured using bioelectrical impedance analysis before and after colorectal surgery.
The unit of measure will be kilograms.
The outcome will be reported as the change from preoperative baseline in fat-free mass.
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From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colonic Diseases
- Pathological Conditions, Signs and Symptoms
- Colorectal Neoplasms
- Postoperative Complications
- Amino Acids, Peptides, and Proteins
- Proteins
- Antibodies, Monoclonal, Humanized
- Antibodies, Monoclonal
- Antibodies
- Immunoglobulins
- Immunoproteins
- Blood Proteins
- Serum Globulins
- Globulins
- Cetuximab
Other Study ID Numbers
- OI-2023-BIA
- ERIDNPVO-0070/2023 (Other Identifier: Ethics Committee of the Institute of Oncology Ljubljana)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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