Changes in Coagulation in Colorectal Cancer Patients Undergoing Surgical Treatment (CONTEST)

University of Aarhus

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT04744688

1-10-72-212-20

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria (both groups):

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

Trial design

90 participants in 2 patient groups

48 cytoreductive surgery with HIPEC patients

Description:

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

48 minimally invasive patients

Description:

48 rectal cancer patients undergoing minimally invasive rectal cancer resection