Perioperative Outcomes After Neoadjuvant Therapy in Colorectal Cancer

NCT07422974 | Recruiting

• 1 other identifier: CRC-NEO-001
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Carcinoma (CRC); Neoadjuvant Therapy; Endothelial Dysfunction; Complications

Keywords

Colorectal Carcinoma; Neoadjuvant Therapy; Microvascular Density; Treatment Outcome; Wound Healing; Critical care

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• von Willebrand factor

  Once, before surgery

• Intraoperative hemodynamics

  During surgery

• Vasoactive drugs

  During surgery

• Blood transfusion during surgery

  During surgery

• Postoperative laboratory parameters

  16 hours after surgery

Other Outcomes (8)

• Postoperative complications - cardiovascular

  up to 30 days from the surgery

• Postoperative complications - thromboembolic events

  up to 30 days from the surgery

• Postoperative complications - bleeding

  up to 30 days after surgery

Study Arms (2)

Patients who received neoadjuvant therapy.

The study will include 34 consecutive patients undergoing colorectal cancer surgery who received neoadjuvant therapy.

Procedure: Skin and subcutaneous tissue sampling for histopathological analysis; Procedure: Blood sampling for laboratory analyses before and after surgery

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.

Procedure: Skin and subcutaneous tissue sampling for histopathological analysis; Procedure: Blood sampling for laboratory analyses before and after surgery

Interventions

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).

Patients who did not receive neoadjuvant therapy, control group.; Patients who received neoadjuvant therapy.

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.

Patients who did not receive neoadjuvant therapy, control group.; Patients who received neoadjuvant therapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Osijek University Hospital: lead

Study Sites (1)

KBC Osijek

Osijek, 31000, Croatia

RECRUITING

Related Publications (7)

• 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.

  PMID: 38460441 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.

  PMID: 36141305 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.

  PMID: 32387305 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.

  PMID: 37205202 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.

  PMID: 28599468 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.

  PMID: 32968958 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.

  PMID: 34537139 BACKGROUND

Related Links

• Cancer today; Data visualization tools for exploring the global cancer burden in 2022

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Blood Specimen Collection; Postoperative Period

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Perioperative Period; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Josipa Glavas Tahtler, MD

  KBC Osijek, MEFOS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josipa Glavas Tahtler, MD

CONTACT

00385959080119; glavasjosipa@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 20, 2026
• Study Start: January 9, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-01

Locations

CR (1)