Perioperative Outcomes After Neoadjuvant Therapy in Colorectal Cancer

ConditionsColorectal Carcinoma (CRC)Complications Neoadjuvant Therapy Endothelial Dysfunction

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorOsijek University Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

The study will include adult patients (≥18 years) with histologically confirmed colorectal cancer who are scheduled for elective surgery, laparoscopic or open. Both sexes will be included in the study. The study population includes patients who received neoadjuvant therapy (study group) and those who did not (control group).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Skin and subcutaneous tissue sampling for histopathological analysis
Procedure/Surgery
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).
Blood sampling for laboratory analyses before and after surgery
Procedure/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.

Treatment groups

68 Participants

are divided into 2 treatment groups

Group A: Patients who received neoadjuvant therapy.2 interventions

Group B: Patients who did not receive neoadjuvant therapy, control group.2 interventions

Trial outcomes

Primary outcomes

Analysis of microvascular density

Imunohistochemical analysis of skin and subcutaneous tissue samples to quantify microvascular density using CD31

Time frame

Assessed on tissue samples collected during surgery

Degree of skin fibrosis

Histopathological analysis of skin and subcutaneous tissue samples to quantify fibrosis

Time frame

Assessed on tissue samples collected during surgery

Secondary outcomes

von Willebrand factor

Level of von Willebrand factor

Time frame

Once, before surgery

Intraoperative hemodynamics

Monitoring of hypotension during surgery

Time frame

During surgery

Vasoactive drugs

Need for the use of vasoactive drugs during surgery

Time frame

During surgery

Blood transfusion during surgery

Need for blood product transfusions

Time frame

During surgery

Other outcomes

Postoperative complications - cardiovascular

New-onset arrhythmia

Time frame

up to 30 days from the surgery

Postoperative complications - thromboembolic events

Clinically significant thromboembolic incident recorded in medical history

Time frame

up to 30 days from the surgery

Postoperative complications - bleeding

Any bleeding registered in medical record

Time frame

up to 30 days after surgery

Postoperative complications - wound infection

any wound complication requiring wound swabs, wound revision or surgical intervention

Time frame

Up to 30 days from the surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Osijek University Hospital

Lead sponsor

Source ClinicalTrials.gov

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