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NCT Number: NCT07404527

Bioelectrical Impedance Analysis for Perioperative Fluid Evaluation in Colorectal Cancer 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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Fluid Imbalance Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bioelectrical Impedance Analysis

Diagnostic Test

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.

Primary outcomes

  1. Percentage of Participants With Postoperative Complications Within 30 Days After Colorectal Surgery

    Time frame: Up to 30 days after colorectal surgery.

    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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    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.

  4. 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.

    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.

  5. 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.

    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.

Sponsors and collaborators

Lead sponsor

Institute of Oncology Ljubljana

Other

Registry information

Official study title

Usefulness of Bioelectrical Impedance Analysis for Perioperative Fluid Evaluation and Complication Prediction in Oncological Patients Undergoing Colorectal Surgery

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 11, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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