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| ID | Type | Description | Link |
|---|---|---|---|
| ERIDNPVO-0070/2023 | Other Identifier | Ethics Committee of the Institute of Oncology Ljubljana |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Oncology Ljubljana | Ljubljana | 1000 | Slovenia |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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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.
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| 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. | 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. | 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. | 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. | From preoperative baseline to postoperative assessment, up to 30 days after colorectal surgery. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |