Bioelectrical Impedance Analysis for Perioperative Fluid Evaluation in Colorectal Cancer Surgery

NCT07404527 | Active Not Recruiting

• 2 other identifiers: OI-2023-BIAERIDNPVO-0070/2023
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer; Fluid Imbalance; Postoperative Complications

Keywords

Bioelectrical Impedance Analysis; BIA; Colorectal Surgery

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Postoperative Complications Within 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.

  Up to 30 days after colorectal surgery.

Secondary Outcomes (5)

• Change From Baseline in Total Body Water Assessed by Bioelectrical Impedance Analysis

  From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery.

• Change From Baseline in Extracellular Water Assessed by Bioelectrical Impedance Analysis

  From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery.

• Change From Baseline in Intracellular Water Assessed by Bioelectrical Impedance Analysis

  From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery.

• Change From Baseline in Extracellular Water to Total Body Water Ratio Assessed by Bioelectrical Impedance Analysis

  From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery.

• Change From Baseline in Fat-Free Mass Assessed by Bioelectrical Impedance Analysis

  From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery.

Study Arms (1)

Bioelectrical Impedance Analysis

EXPERIMENTAL

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.

Diagnostic Test: Bioelectrical Impedance Analysis

Interventions

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.

Bioelectrical Impedance Analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All enrolled participants undergo perioperative bioelectrical impedance analysis (BIA) measurements in addition to standard clinical evaluation. BIA parameters are evaluated in relation to perioperative fluid status and postoperative complications.

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start: October 24, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)