Changes in Coagulation in Colorectal Cancer Patients Undergoing Surgical Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-06

Study Completion Date

2024-05-27

Brief Summary

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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.

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Detailed Description

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Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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48 cytoreductive surgery with HIPEC patients

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

No interventions assigned to this group

48 minimally invasive patients

48 rectal cancer patients undergoing minimally invasive rectal cancer resection

No interventions assigned to this group

Eligibility Criteria

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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