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Changes in Coagulation in Colorectal Cancer Patients Undergoing Surgical Treatment

NCT04744688 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2024-05-29

No results posted yet for this study

Summary

Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) has prolonged the survival substantially for selected patients with peritoneal metastases from colorectal cancer.Bleeding and thromboembolic disease have been reported as postoperative complications related to this advanced open surgical treatment. However, perioperative changes in coagulation and fibrinolysis are only sparsely reported in the literature.The mainstay of treatment with curative intend of none-advanced colorectal cancer is minimally invasive laparoscopic surgery followed by adjuvant chemotherapy. The approach is considered associated with a lower risk of thromboembolic disease than open surgery. Despite differences in extent of surgery and thromboembolic risk the same extended thromboprophylaxis regimen for 28 days is currently prescribed to patients undergoing cytoreductive surgery with HIPEC as well as minimally invasive rectal cancer resection. This study aims to investigate all parts of the coagulation system and fibrinolysis, and thereby thromboembolic risk and potential bleeding in two groups of patients with different extent of surgical trauma: 1) Colorectal cancer patients undergoing cytoreductive surgery with HIPEC and 2) rectal cancer patients undergoing minimal invasive rectal cancer resection. Our hypothesis is that patients undergoing cytoreductive surgery with HIPEC are exposed to more aggravated alterations of coagulation and fibrinolysis than patients undergoing minimally invasive rectal cancer resection.

Conditions

  • Peritoneal Metastases
  • Peritoneal Carcinomatosis
  • Colorectal Neoplasms Malignant
  • Intestinal Neoplasms
  • Cytoreductive Surgery
  • Venous Thromboembolism
  • Bleeding
  • Laparoscopic Surgery
  • Coagulation
  • Surgical Procedures, Operative
  • Postoperative Complications
  • Laparoscopy
  • Minimally Invasive Surgical Procedures
  • Surgical Oncology

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Anne-Mette Hvas, MD, PhD · Thrombosis and Haemostasis Research Unit, Department of Clinical Biochemistry, Aarhus University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-06
Primary Completion
2023-12-15
Completion
2024-05-27

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04744688 on ClinicalTrials.gov