Colorectal Carcinoma (CRC), Complications, Endothelial Dysfunction, Neoadjuvant Therapy
Conditions
Keywords
Colorectal Carcinoma, Neoadjuvant Therapy, Microvascular Density, Treatment Outcome, Wound Healing, Critical care
Brief 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.
Detailed description
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.
Interventions
PROCEDURESkin and subcutaneous tissue sampling for histopathological analysis
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).
PROCEDUREBlood sampling for laboratory analyses before and after surgery
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.
Sponsors
Osijek University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of skin fibrosis | Assessed on tissue samples collected during surgery | Histopathological analysis of skin and subcutaneous tissue samples to quantify fibrosis |
| Analysis of microvascular density | Assessed on tissue samples collected during surgery | Imunohistochemical analysis of skin and subcutaneous tissue samples to quantify microvascular density using CD31 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative laboratory parameters - CRP | 16 hours after surgery | C-reactive protein level |
| von Willebrand factor | Once, before surgery | Level of von Willebrand factor |
| Intraoperative hemodynamics | During surgery | Monitoring of hypotension during surgery |
| Blood transfusion during surgery | During surgery | Need for blood product transfusions |
| Vasoactive drugs | During surgery | Need for the use of vasoactive drugs during surgery |
| Postoperative laboratory parameters | 16 hours after surgery | Procalcitonin level |
Countries
Croatia
Contacts
CONTACTJosipa Glavas Tahtler, MD
PRINCIPAL_INVESTIGATORJosipa Glavas Tahtler, MD
KBC Osijek, MEFOS
Outcome results
None listed