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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.
The study hypothesis is that neoadjuvant therapy of colorectal cancer leads to endothelial dysfunction, reduced microvascular density, and tissue fibrosis, and therefore contributes to the occurrence of perioperative complications. The primary objective of the study is to assess the association between microvascular density and neoadjuvant therapy, identify differences in biomarkers and demographic factors between patients with neoadjuvant therapy and those without neoadjuvant therapy, and compare clinical outcomes between patients treated with neoadjuvant therapy and those who underwent surgery as initial treatment. Secondary objectives are to determine the association of microvascular density and fibrosis in surgical wound tissue with postoperative complications and wound healing complications, and identify differences in biomarkers between patients with and without perioperative complications.
The study was approved by the Ethics Committee of the Osijek Clinical Hospital Center.
The study will include 34 consecutive patients undergoing colorectal cancer surgery who received neoadjuvant therapy and 34 patients undergoing colorectal cancer surgery who did not receive neoadjuvant therapy but whose first-line treatment is surgery. During the surgery, a skin and subcutaneous tissue sample will be taken for pathohistological analysis of microvascular density and tissue fibrosis, allowing for a more detailed assessment of microvascular changes associated with perioperative complications. It is planned to follow the patient from the surgery until the end of hospitalization, and data on post-discharge complications will be tracked through the medical history in the Hospital Information System one month after discharge from the hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who received neoadjuvant therapy. | The study will include 34 consecutive patients undergoing colorectal cancer surgery who received neoadjuvant therapy. |
| |
| Patients who did not receive neoadjuvant therapy, control group. | The control group will include 34 patients undergoing colorectal cancer surgery who have not received neoadjuvant therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin and subcutaneous tissue sampling for histopathological analysis | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of microvascular density | Imunohistochemical analysis of skin and subcutaneous tissue samples to quantify microvascular density using CD31 | Assessed on tissue samples collected during surgery |
| Degree of skin fibrosis | Histopathological analysis of skin and subcutaneous tissue samples to quantify fibrosis | Assessed on tissue samples collected during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| von Willebrand factor | Level of von Willebrand factor | Once, before surgery |
| Intraoperative hemodynamics | Monitoring of hypotension during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications - cardiovascular | New-onset arrhythmia | up to 30 days from the surgery |
| Postoperative complications - thromboembolic events | Clinically significant thromboembolic incident recorded in medical history |
Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josipa Glavas Tahtler, MD | Contact | 00385959080119 | glavasjosipa@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Josipa Glavas Tahtler, MD | KBC Osijek, MEFOS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KBC Osijek | Recruiting | Osijek | 31000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38460441 | Background | Elawa S, Fredriksson I, Steinvall I, Zotterman J, Farnebo S, Tesselaar E. Skin perfusion and oxygen saturation after mastectomy and radiation therapy in breast cancer patients. Breast. 2024 Jun;75:103704. doi: 10.1016/j.breast.2024.103704. Epub 2024 Mar 6. | |
| 36141305 | Background | Afolabi H, Salleh SM, Zakaria Z, Ch'ng ES, Mohd Nafi SN, Abdul Aziz AAB, Al-Mhanna SB, Wada Y, Abdulrahman AS. The Prediction of Survival Outcome and Prognosis Factor in Association with Comorbidity Status in Patients with Colorectal Cancer: A Research-Based Study. Healthcare (Basel). 2022 Sep 5;10(9):1693. doi: 10.3390/healthcare10091693. |
| Label | URL |
|---|---|
| Cancer today; Data visualization tools for exploring the global cancer burden in 2022 | View source |
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Sharing of individual participant data (IPD) may be limited due to participant privacy, regulatory requirements, or informed consent restrictions. Data access will only be granted if ethical and legal conditions allow.
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| Blood sampling for laboratory analyses before and after surgery | Procedure | 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. |
|
| During surgery |
| Vasoactive drugs | Need for the use of vasoactive drugs during surgery | During surgery |
| Blood transfusion during surgery | Need for blood product transfusions | During surgery |
| Postoperative laboratory parameters | Procalcitonin level | 16 hours after surgery |
| Postoperative laboratory parameters - CRP | C-reactive protein level | 16 hours after surgery |
| up to 30 days from the surgery |
| Postoperative complications - bleeding | Any bleeding registered in medical record | up to 30 days after surgery |
| Postoperative complications - wound infection | any wound complication requiring wound swabs, wound revision or surgical intervention | Up to 30 days from the surgery |
| Postoperative complications - anastomotic dehiscence | anastomotic dehiscence registered by abdominal surgon in medical records | Up to 30 days from the surgery |
| Patient Outcome - Mortality | Mortality registered in medical records | 30 days from surgery |
| Patient Outcome - ICU stay | Length of ICU stay | 30 days from surgery |
| Patient Outcome - hospital stay | Length of hospital stay | 30 days from surgery |
| 32387305 | Background | Chen CC, Wu ML, Huang KC, Huang IP, Chung YL. The Effects of Neoadjuvant Treatment on the Tumor Microenvironment in Rectal Cancer: Implications for Immune Activation and Therapy Response. Clin Colorectal Cancer. 2020 Dec;19(4):e164-e180. doi: 10.1016/j.clcc.2020.04.002. Epub 2020 Apr 16. |
| 37205202 | Background | Admasu FT, Dejenie TA, Ayehu GW, Zewde EA, Dessie G, Adugna DG, Enyew EF, Geto Z, Abebe EC. Evaluation of thromboembolic event, basic coagulation parameters, and associated factors in patients with colorectal cancer: a multicenter study. Front Oncol. 2023 May 2;13:1143122. doi: 10.3389/fonc.2023.1143122. eCollection 2023. |
| 28599468 | Background | Lee S, Huh SJ, Oh SY, Koh MS, Kim SH, Lee JH, Han JY, Choi HJ, Kim SJ, Kim HJ. Clinical significance of coagulation factors in operable colorectal cancer. Oncol Lett. 2017 Jun;13(6):4669-4674. doi: 10.3892/ol.2017.6058. Epub 2017 Apr 20. |
| 32968958 | Background | Gamboa AC, Lee RM, Turgeon MK, Varlamos C, Regenbogen SE, Hrebinko KA, Holder-Murray J, Wiseman JT, Ejaz A, Feng MP, Hawkins AT, Bauer P, Silviera M, Maithel SK, Balch GC. Impact of Postoperative Complications on Oncologic Outcomes After Rectal Cancer Surgery: An Analysis of the US Rectal Cancer Consortium. Ann Surg Oncol. 2021 Mar;28(3):1712-1721. doi: 10.1245/s10434-020-08976-8. Epub 2020 Sep 23. |
| 34537139 | Background | Hanna DN, Hawkins AT. Colorectal: Management of Postoperative Complications in Colorectal Surgery. Surg Clin North Am. 2021 Oct;101(5):717-729. doi: 10.1016/j.suc.2021.05.016. Epub 2021 Jul 30. |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D011184 | Postoperative Period |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D059035 | Perioperative Period |
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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