Clinical trial · Observational
Changes in Coagulation in Colorectal Cancer Patients Undergoing Surgical Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bleeding | — | UNRESOLVED | — |
| Coagulation | — | UNRESOLVED | — |
| Colorectal Neoplasms Malignant | — | UNRESOLVED | — |
| Cytoreductive Surgery | — | UNRESOLVED | — |
| Intestinal Neoplasms | Intestinal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Laparoscopic Surgery | — | UNRESOLVED | — |
| Laparoscopy | — | UNRESOLVED | — |
| Minimally Invasive Surgical Procedures | — | UNRESOLVED | — |
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- 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)
- label
- 48 minimally invasive patients
- description
- 48 rectal cancer patients undergoing minimally invasive rectal cancer resection
Primary outcomes (1)
- measure
- The difference between changes in concentration of prothrombin fragment 1+2.
- timeFrame
- Data will be analyzed, assessed, and presented within three years.
- description
- 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.
Secondary outcomes (42)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available