Changes in Coagulation in Colorectal Cancer Patients Undergoing Surgical Treatment

NCT04744688 | Completed DMC

• 1 other identifier: 1-10-72-212-20
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Bleeding; Venous thromboembolism; Coagulation; Cancer surgery; Thromboprophylaxis; Colorectal cancer; Cancer; Peritoneal metastases; Postoperative complications; Rectal cancer

Outcome Measures

Primary Outcomes (1)

• The difference between changes in concentration of prothrombin fragment 1+2.

  The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.

  Data will be analyzed, assessed, and presented within three years.

Secondary Outcomes (42)

• The difference between changes in platelet concentration from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.

  Data will be analyzed, assessed, and presented within three years

• The difference between changes in concentration of immature platelets from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.

  Data will be analyzed, assessed, and presented within three years

• The difference between changes in concentration of plasma selectin from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.

  Data will be analyzed, assessed, and presented within three years

• The difference between changes in activated partial thromboplastin time "APTT" (seconds) from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.

  Data will be analyzed, assessed, and presented within three years.

• The difference between changes in international normalized ratio "INR" (seconds) from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.

  Data will be analyzed, assessed, and presented within three years.

Study Arms (2)

48 cytoreductive surgery with HIPEC patients

48 patients with peritoneal metastases from colorectal cancer undergoing cytoreductive surgery with HIPEC (cytoreductive surgery with HIPEC patients)

48 minimally invasive patients

48 rectal cancer patients undergoing minimally invasive rectal cancer resection

Eligibility Criteria

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

Study Population

This study will include patients with peritoneal metastases from colorectal cancer undergoing cytoreductive surgery with HIPEC and rectal cancer patients undergoing minimally invasive rectal cancer resection. Patients will be identified at the outpatient clinic and undergo surgical treatment at the Department of Surgery, Aarhus University Hospital, Denmark.

You may qualify if:

• Cytoreductive surgery with HIPEC patients:
• Able to give informed consent
• Age ≥ 18 years
• Diagnosed with peritoneal metastases from colorectal cancer
• Planned to undergo cytoreductive surgery with HIPEC
• Minimally invasive rectal cancer patients:
• Able to give informed consent
• Age ≥ 18 years
• Diagnosed with rectal cancer
• Planned to undergo minimal invasive rectal cancer resection with one of: total mesorectal excision, partial mesorectal excision or abdominoperineal excision

You may not qualify if:

• Thromboembolic event within 90 days before surgery
• Secondary malignancy within previous 5 years or concomitant, except non-melanoma skin cancer.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (2)

Aarhus University Hospital

Aarhus, Aarhus N, 8200, Denmark

Location

Thrombosis and Haemostasis Research Unit, Department for Clinical Biochemistry, Aarhus University Hospital

Aarhus N, 8000, Denmark

Location

MeSH Terms

Conditions

Peritoneal Neoplasms; Colonic Neoplasms; Intestinal Neoplasms; Venous Thromboembolism; Hemorrhage; Thrombosis; Postoperative Complications; Colorectal Neoplasms; Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Rectal Diseases

Study Officials

• Anne-Mette Hvas, MD, PhD

  Thrombosis and Haemostasis Research Unit, Department of Clinical Biochemistry, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: February 9, 2021
• Study Start: April 6, 2021
• Primary Completion: December 15, 2023
• Study Completion: May 27, 2024
• Last Updated: May 29, 2024

Record last verified: 2020-12

Locations

DK (2)