Effect of pre-surgery (neoadjuvant) therapy on surgical outcomes in colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study compares 34 patients who received neoadjuvant therapy with 34 patients undergoing surgery as first-line treatment to examine microvascular density, endothelial function, and tissue fibrosis. During surgery, skin and subcutaneous tissue samples will be taken for histopathological analysis of microvascular density and fibrosis, and blood samples will be obtained before and after surgery for biomarker testing. Patients will be followed until hospital discharge and medical records will be reviewed one month after surgery to capture postoperative and wound-healing complications. The working hypothesis is that neoadjuvant therapy reduces microvascular density and increases tissue fibrosis, contributing to higher perioperative complication rates.

Why it matters

Who can join: the full rules

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

Where it's running

• KBC Osijek
  Osijek, Croatia Recruiting

Study contacts

• Principal investigator: Josipa Glavas Tahtler, MD — KBC Osijek, MEFOS
• Study coordinator: Josipa Glavas Tahtler, MD
• Email: glavasjosipa@yahoo.com
• Phone: 00385959080119

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.