Effect of pre-surgery (neoadjuvant) therapy on surgical outcomes in colorectal cancer
The Impact of Neoadjuvant Therapy on Perioperative Complications and Treatment Outcomes in Patients Undergoing Colorectal Cancer Resection
Osijek University Hospital · NCT07422974
We will test whether pre-surgery (neoadjuvant) therapy changes tiny blood vessels, increases tissue scarring, and raises the risk of wound and other perioperative complications in adults having colorectal cancer surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Osijek University Hospital (other) |
| Locations | 1 site (Osijek) |
| Trial ID | NCT07422974 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed colorectal cancer scheduled for elective colorectal surgery at KBC Osijek who either received neoadjuvant therapy or will undergo surgery as first-line treatment are ideal candidates.
Not a fit: Patients undergoing emergency surgery, those on chronic corticosteroids, or those unable to provide informed consent are excluded and would not benefit from participation.
Why it matters
Potential benefit: If a link is found between neoadjuvant therapy and impaired microvasculature or wound healing, clinicians could better predict and reduce surgical complications through adjusted timing, monitoring, or preventive measures.
How similar studies have performed: Previous research indicates chemotherapy and radiotherapy can impair wound healing and microvascular function, but prospective comparisons of surgical skin microvascular density specifically in colorectal cancer patients are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Osijek
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colorectal Carcinoma, Complications, Neoadjuvant Therapy, Endothelial Dysfunction, Microvascular Density, Treatment Outcome, Wound Healing, Critical care