NCT04744688Completed
Changes in Coagulation in Colorectal Cancer Patients Undergoing Surgical Treatment
Source: ClinicalTrials.gov · Last updated 29 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 90 (actual)
- First submitted
- 4 Jan 2021
- Start date
- 6 Apr 2021
- Primary completion date
- 15 Dec 2023
- Lead sponsor
- University of Aarhus
- Diseases
- Colorectal cancer
- NCT number
- NCT04744688
What you commit to
- Study type: Observational
- Participants enrolled: 90
- From 6 Apr 2021 to the primary completion date, 15 Dec 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Thromboembolic event within 90 days before surgery
- Secondary malignancy within previous 5 years or concomitant, except non-melanoma skin cancer.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Thrombosis and Haemostasis Research Unit, Department for Clinical Biochemistry, Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.