- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01244022
Cytokine Changes After Colorectal Cancer Resection
Postoperative Serum Cytokine Changes After Radical Resection of Colorectal Cancer
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Every surgical intervention represents a stress for patient's organism. During the operation, numerous changes in the patient's metabolism take place, that are termed surgical stress response. Leading cause of surgical stress response is tissue destruction that always accompanies operations. Surgical stress response is effected through activation of hypothalamus-pituitary-adrenal axis and through sympathetic activation.
The consequences of surgical stress response are numerous. Surgical stress response is essential to uneventful postoperative recovery. On the other hand, excessive surgical stress response may lead to serious postoperative complications, such as heart and kidney failure, venous thrombosis, disruption of operative wound and wound infection.
In prior studies the investigators have shown the kinetics of postoperative serum interleukin changes after radical resection of gastric cancer.
This study aims at determining reliable markers of surgical stress response severity in patients undergoing radical resection of colorectal cancer.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
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Zagreb, Kroatien, 10000
- University Hospital Dubrava
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Pathohistologically verified colorectal cancer
Exclusion Criteria:
- Distant metastases noticed before or during surgery
- History of autoimmune diseases or immunodeficiencies
- Use of immunomodulatory drugs within 1 year prior to surgery
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Colorectal cancer patients
Patients with pathohistologically verified colorectal cancer or adenoma with epithelial dysplasia
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Open radical resection of colorectal cancer, according to oncological principals, depending on the tumor site
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Postoperative changes of serum cytokine levels
Tidsramme: 1 day, 2 days and 7 days postoperatively
|
Serum cytokine levels will be determined at 1st, 2nd and 7th postoperative day and compared to preoperative values.
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1 day, 2 days and 7 days postoperatively
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Early postoperative complications
Tidsramme: Within one month after surgery
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Within one month after surgery
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Drazen Servis, M.D., Ph.D., University Hospital Dubrava
Publikationer og nyttige links
Generelle publikationer
- Servis D, Busic Z, Stipancic I, Patrlj L, Gagro A. Serum cytokine changes after gastric resection or gastrectomy for gastric cancer. Hepatogastroenterology. 2008 Sep-Oct;55(86-87):1868-72.
- Etherek L, Servis D, Unic A. Soluble Triggering Receptor Expressed on Myeloid Cells-1 and Inflammatory Markers in Colorectal Cancer Surgery: A Prospective Cohort Study. Chin Med J (Engl). 2017 Nov 20;130(22):2691-2696. doi: 10.4103/0366-6999.218022.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DS-P03112010
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