Using bioelectrical impedance to guide fluids during colorectal cancer surgery
Usefulness of Bioelectrical Impedance Analysis for Perioperative Fluid Evaluation and Complication Prediction in Oncological Patients Undergoing Colorectal Surgery
This trial will test whether using bioelectrical impedance measurements to guide fluid decisions during colorectal cancer surgery helps patients recover with fewer complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Oncology Ljubljana Academic / other |
| Drugs / interventions | cetuximab, chemotherapy |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT07404527 on ClinicalTrials.gov |
What this trial studies
The protocol describes using bioelectrical impedance analysis (BIA) around the time of colorectal cancer surgery to inform perioperative fluid management and monitor fluid status. Outcomes would likely include postoperative complications, recovery metrics, and length of stay. The provided documents also describe SARC-F screening for sarcopenia in patients with gastrointestinal cancers and referral to nutrition services if positive. Note: some registry fields (listed intervention and eligibility) appear inconsistent with the BIA/surgery focus, referencing systemic cetuximab therapy and head and neck cancer eligibility.
Who should consider this trial
Good fit: Adults scheduled for colorectal cancer surgery who can undergo perioperative monitoring at the study site are the intended participants.
Not a fit: People not having colorectal surgery or those treated at different centers or with incompatible medical conditions are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, tailoring perioperative fluids with BIA could reduce complications and speed recovery after colorectal cancer surgery.
How similar studies have performed: BIA-guided fluid management has produced mixed but promising results in perioperative settings, while SARC-F is a validated but moderately sensitive screening tool for sarcopenia.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Adult patients (≥18 years of age). Histologically confirmed head and neck cancer. Indication for induction chemotherapy followed by chemoradiotherapy with cetuximab. Adequate organ function as required by the study protocol. Ability to provide informed consent. Exclusion Criteria: * Prior systemic therapy or radiotherapy for head and neck cancer. Presence of uncontrolled comorbidities that would preclude study treatment. Known hypersensitivity to cetuximab or components of the treatment regimen. Pregnancy or breastfeeding.
Where this trial is running
Ljubljana
- Institute of Oncology Ljubljana — Ljubljana, Slovenia (Recruiting)
Study contacts
- Study coordinator: Klavdija Korošec
- Email: kkorosec@onko-i.si
- Phone: +386 31630065
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.