Perioperative Outcomes After Neoadjuvant Therapy in Colorectal Cancer
The Impact of Neoadjuvant Therapy on Perioperative Complications and Treatment Outcomes in Patients Undergoing Colorectal Cancer Resection
Osijek University Hospital
68 participants
Jan 9, 2026
OBSERVATIONAL
Conditions
Summary
This prospective study investigates the effects of neoadjuvant therapy on endothelial function, microvascular tissue density, and tissue fibrosis in patients with colorectal cancer and their association with perioperative complications. The primary objective is to assess differences in microvascular tissue density between patients who received neoadjuvant therapy and those who did not, biomarkers, and demographic factors between patients who received neoadjuvant therapy and those who underwent surgery as initial treatment, and to compare clinical outcomes. The study will include 34 patients treated with neoadjuvant therapy and 34 patients for whom surgery is the first-line treatment. Patients will be followed until discharge from the hospital, and complications after discharge will be monitored through medical records one month after surgery.
Eligibility
Inclusion Criteria6
- Adults aged ≥18 years with histologically confirmed colorectal cancer
- Planned surgical treatment for colorectal cancer (either laparoscopic LPSC or open laparotomy)
- Ability to understand the study protocol and provide written informed consent.
- Both sexes
- ASA classification II or III
- Patients who received neoadjuvant therapy is investigational group and patients who did not receive neoadjuvant therapy is control group
Exclusion Criteria5
- Age \<18 years
- Patients who are not conscious, not oriented, or unable to provide informed consent
- Patients unable to understand the study protocol
- Emergency surgical cases
- Patients on chronic corticosteroid therapy
Interventions
During the operation, a sample of skin and subcutaneous tissue approximately 1 cm long and 2 mm wide will be taken from the surgical incision site. The sample will be taken from an area that has not previously been affected by radiotherapy and will not compromise patient safety. Histopathological analysis will be performed in the Clinical Department of Pathology and Forensic Medicine. The degree of fibrosis of the skin and subcutaneous tissue and the microvascular density of the skin tissue will be analyzed using the marker CD31 (PECAM-1).
Before surgery, blood samples will be taken for laboratory analysis. The following parameters will be assessed: leukocytes, hemoglobin, hematocrit, platelets, prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), fibrinogen, urea, creatinine, blood glucose, potassium, AST, ALT, GGT, CRP, albumin, cholinesterase, IL-6, von Willebrand factor, and endothelin-1. Laboratory findings will be monitored 16 hours after surgery (leukocytes, hemoglobin, hematocrit, platelets, PV, fibrinogen, d-dimers, urea, creatinine, GUK, K, CRP, albumin, PCT, cholinesterase, IL-6) and before discharge from the hospital (leukocytes, hemoglobin, hematocrit, platelets, PV, urea, creatinine, GUK, K, CRP, albumin). Blood sampling will be conducted according to standard clinical protocols, ensuring patient safety and minimal discomfort.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07422974