Colorectal CancerNCT07404527
Bioelectrical Impedance Analysis for Perioperative Fluid Evaluation in Colorectal Cancer Surgery
A study testing Bioelectrical Impedance Analysis in people with Colorectal Cancer and Postoperative Complications, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Postoperative Complications, Fluid Imbalance
- What is being tested?
- Bioelectrical Impedance Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteSlovenia
- Study dates
- 24 Oct 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Bioelectrical Impedance Analysis
- Keywords
- Bioelectrical Impedance Analysis, BIA, Colorectal Surgery
- Medical subject headings
- Colorectal Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioelectrical Impedance AnalysisDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Bioelectrical Impedance Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 days after colorectal surgery.
Secondary outcomes (5)
Change From Baseline in Total Body Water Assessed by Bioelectrical Impedance Analysis
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.
Measured: From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery.
Change From Baseline in Extracellular Water Assessed by Bioelectrical Impedance Analysis
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.
Measured: From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery.
Change From Baseline in Intracellular Water Assessed by Bioelectrical Impedance Analysis
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.
Measured: 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
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.
Measured: 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
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.
Measured: From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start24 Oct 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404527
- Sponsor's protocol ID
- OI-2023-BIA
- Other IDs
- ERIDNPVO-0070/2023
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Bioelectrical Impedance Analysis for Perioperative Fluid Evaluation and Complication Prediction in Oncological Patients Undergoing Colorectal Surgery
- ClinicalTrials.gov ID
- NCT07404527
- Acronym / sponsor ID
- OI-2023-BIA
- Keywords
- Bioelectrical Impedance Analysis, BIA, Colorectal Surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bioelectrical Impedance Analysis | Experimental | Diagnostic Test: Bioelectrical Impedance AnalysisOncological 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioelectrical Impedance AnalysisBioelectrical 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. | Diagnostic test | Bioelectrical Impedance Analysis |
Primary outcome
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioelectrical Impedance Analysis in people with Colorectal Cancer and Postoperative Complications, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Postoperative Complications Within 30 Days After Colorectal Surgery (time frame: Up to 30 days after colorectal surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.