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RECRUITING
NCT07422974

Perioperative Outcomes After Neoadjuvant Therapy in Colorectal Cancer

Sponsor: Osijek University Hospital

View on ClinicalTrials.gov

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.

Official title: The Impact of Neoadjuvant Therapy on Perioperative Complications and Treatment Outcomes in Patients Undergoing Colorectal Cancer Resection

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

68

Start Date

2026-01-09

Completion Date

2027-05-01

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

PROCEDURE

Skin 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).

PROCEDURE

Blood 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.

Locations (1)

KBC Osijek

Osijek, Croatia