RecruitingNCT07422974

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


Sponsor

Osijek University Hospital

Enrollment

68 participants

Start Date

Jan 9, 2026

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how pre-treatment with radiation or chemotherapy (called neoadjuvant therapy) affects surgical outcomes in people with colorectal cancer. Researchers want to understand whether receiving this treatment before surgery leads to different results compared to going straight to surgery. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with colorectal cancer confirmed by a tissue biopsy - You are planning to have surgery (either laparoscopic or open) for your colorectal cancer - You are in reasonably good health (ASA classification II or III) **You may NOT be eligible if...** - You are under 18 years old - You are unable to give informed consent - Your surgery is an emergency procedure - You are on long-term steroid (corticosteroid) medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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.


Locations(1)

KBC Osijek

Osijek, Croatia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07422974


Related Trials