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.
The study hypothesis is that neoadjuvant therapy of colorectal cancer leads to endothelial dysfunction, reduced microvascular density, and tissue fibrosis, and therefore contributes to the occurrence of perioperative complications. The primary objective of the study is to assess the association between microvascular density and neoadjuvant therapy, identify differences in biomarkers and demographic factors between patients with neoadjuvant therapy and those without neoadjuvant therapy, and compare clinical outcomes between patients treated with neoadjuvant therapy and those who underwent surgery as initial treatment. Secondary objectives are to determine the association of microvascular density and fibrosis in surgical wound tissue with postoperative complications and wound healing complications, and identify differences in biomarkers between patients with and without perioperative complications. The study was approved by the Ethics Committee of the Osijek Clinical Hospital Center. The study will include 34 consecutive patients undergoing colorectal cancer surgery who received neoadjuvant therapy and 34 patients undergoing colorectal cancer surgery who did not receive neoadjuvant therapy but whose first-line treatment is surgery. During the surgery, a skin and subcutaneous tissue sample will be taken for pathohistological analysis of microvascular density and tissue fibrosis, allowing for a more detailed assessment of microvascular changes associated with perioperative complications. It is planned to follow the patient from the surgery until the end of hospitalization, and data on post-discharge complications will be tracked through the medical history in the Hospital Information System one month after discharge from the hospital.
Study Type
OBSERVATIONAL
Enrollment
68
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.
KBC Osijek
Osijek, Croatia
RECRUITINGAnalysis of microvascular density
Imunohistochemical analysis of skin and subcutaneous tissue samples to quantify microvascular density using CD31
Time frame: Assessed on tissue samples collected during surgery
Degree of skin fibrosis
Histopathological analysis of skin and subcutaneous tissue samples to quantify fibrosis
Time frame: Assessed on tissue samples collected during surgery
von Willebrand factor
Level of von Willebrand factor
Time frame: Once, before surgery
Intraoperative hemodynamics
Monitoring of hypotension during surgery
Time frame: During surgery
Vasoactive drugs
Need for the use of vasoactive drugs during surgery
Time frame: During surgery
Blood transfusion during surgery
Need for blood product transfusions
Time frame: During surgery
Postoperative laboratory parameters
Procalcitonin level
Time frame: 16 hours after surgery
Postoperative laboratory parameters - CRP
C-reactive protein level
Time frame: 16 hours after surgery
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