Perioperative Systemic Therapy for Isolated Resectable Colorectal Peritoneal Metastases
NCT02758951
Abdominal Neoplasms, Body Temperature Changes
Genk, Flanders, Belgium
View Trial DetailsNCT Number: NCT04744688
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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Notify Me18 year and older
All sexes
Observational
Aarhus University Hospital, Aarhus, Aarhus N, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Cytoreductive surgery with HIPEC patients:
Minimally invasive rectal cancer patients:
Exclusion criteria
(both groups):
Time frame: Data will be analyzed, assessed, and presented within three years.
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.
Time frame: Data will be analyzed, assessed, and presented within three years
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.
Time frame: Data will be analyzed, assessed, and presented within three years
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.
Time frame: Data will be analyzed, assessed, and presented within three years
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.
Time frame: Data will be analyzed, assessed, and presented within three years.
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.
Time frame: Data will be analyzed, assessed, and presented within three years.
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.
Time frame: Data will be analyzed, assessed, and presented within three years.
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.
Time frame: Data will be analyzed, assessed, and presented within three years.
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.
Time frame: Data will be analyzed, assessed, and presented within three years.
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.
Time frame: Data will be analyzed, assessed, and presented within three years.
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.
Time frame: Data will be analyzed, assessed, and presented within three years.
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.
Thrombin generation will be measured by:
Lagtime (min), time to peak (min), peak thrombin (nM) and endogenous thrombin potential (nM*min).
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes of fibrin clot structure from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Fibrin clot structure will be measured by clot maximum, absorbance (arbitrary units), network density, lysis time (seconds), lysis area (balance between clot formation and lysis).
Time frame: Data will be analyzed, assessed, and presented within three years.
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.
Time frame: Data will be analyzed, assessed, and presented within three years.
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.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from before surgery to the end of surgery (both groups).
ROTEM will include EXTEM, INTEM, FIBTEM, and APTEM by clotting time (seconds), clot formation time (seconds), alpha-angle (degrees), amplitude 10 min after clotting time (mm), maximum clot firmness (mm), lysis index 30 min after clotting time (mm), maximum lysis (mm).
Time frame: Data will be analyzed, assessed, and presented within three years.
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.
Time frame: Data will be analyzed, assessed, and presented within three years.
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.
Time frame: Data will be analyzed, assessed, and presented within three years.
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.
Time frame: Data will be analyzed, assessed, and presented within three years.
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.
Time frame: Data will be analyzed, assessed, and presented within three years.
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.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC. Thrombin generation will be measured by: Lagtime (min), time to peak (min), peak thrombin (nM) and endogenous thrombin potential (nM*min).
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC. Fibrin clot structure will be measured by clot maximum, absorbance (arbitrary units), network density, lysis time (seconds), lysis area (balance between clot formation and lysis).
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery to the end HIPEC.
ROTEM will include EXTEM, INTEM, FIBTEM, and APTEM by clotting time (seconds), clot formation time (seconds), alpha-angle (degrees), amplitude 10 min after clotting time (mm), maximum clot firmness (mm), lysis index 30 min after clotting time (mm), maximum lysis (mm).
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years
Bilateral doppler ultrasonography of the veins in the lower extremities.The scan will be performed within the postoperative period from day 3 to day 7.
Time frame: Data will be analyzed, assessed, and presented within three years
Bilateral doppler ultrasonography of the veins in the lower extremities.The scan will be performed within the postoperative period from day 3 to day 7.
University of Aarhus
Other
Acronym: CONTEST
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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