- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04717648
C-Reactive Protein and Sodium in Predicting Anastomotic Leakage
The Effect of Postoperative C-Reactive Protein and Sodium Value on the Early Prediction of Anastomotic Leaks in Patients Operated on for Colorectal Cancer
Anastomotic leakage is serious morbidity that can develop in patients operated on for colorectal cancer and can reach potentially life-threatening dimensions. Many international studies have been conducted to reduce and eliminate this postoperative complication that may have a mortal course. In these studies, preoperative, perioperative and postoperative factors of the patient, operation techniques, structure of the material used in the operation and multiple factors belonging to the surgeon were held responsible. Intraabdominal sepsis secondary to late anastomotic leakage and subsequent multiorgan failure can cost the patient's life. Anastomotic leaks that develop in patients who have been operated for colorectal cancer; In order to detect patients' postoperative clinical findings, laboratory examinations, imaging tests, and to eliminate them before intraabdominal sepsis develops, studies including many different laboratory and imaging methods have been carried out. Although previous studies have shown that there are many laboratory examinations and imaging methods that can predict anastomotic leaks early, they have many advantages over each other in terms of efficiency, sensitivity, specificity, and cost.
The investigators aimed to investigate the effectiveness of C reactive protein and blood sodium value, as well as their superiority, among the tests that can predict postoperative anastomotic leakage, especially in patients who have undergone a single anastomosis following resection for non-metastatic colorectal cancer.
Studieoversikt
Detaljert beskrivelse
- Investigate the effectiveness of postoperative C-reactive protein and sodium values in predicting anastomotic leakage in the early postoperative period in patients who have undergone anastomosis following resection for non-metastatic colorectal cancer, and their superiority to each other.
- Investigate the effectiveness of these laboratory parameters in developing anastomotic leaks according to tumor location and different age subgroups (<45 years, 45-65 years,> 65 years).
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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İzmir, Tyrkia, 35180
- Tepecik Training and Research Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Patients over the age of 18 who were operated due to elective colorectal cancer
- Patients who are known to have no solid organ metastases in preoperative imaging methods and whose perioperative surgery notes support this finding
- Patients with ileocolic, colocolic, colorectal anastomosis during the operation
- Patients whose postoperative 1,3,5th day C- Reactive protein and sodium values were measured
Exclusion Criteria:
- Patients under the age of 18
- Emergency operated patients
- Patients on a routine dialysis program due to Chronic renal failure
- Patients with a known diagnosis of liver cirrhosis
- Patients who are irresectable during the operation and therefore have undergone palliative surgery
- Patients whose C- Reactive protein and Sodium values were not measured on the postoperative 1, 3, 5th day
- Patients with abdominoperineal resection and no bowel anastomosis during the operation
- Patients who have not undergone ileocolic, colocolic, colorectal or ileorectal anastomosis during the operation.
- Patients found to be metastatic during the operation
- Patients who have undergone additional surgical resection (metastasectomy, etc.) due to solid organ metastasis during the operation
- Patients who have had more than one gastrointestinal anastomosis during the same surgery
- Patients undergoing concurrent hyperthermic intraperitoneal chemotherapy (HIPEC) and / or cytoreductive surgery
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Patients with anastomotic leakage
Post operative anastomotic leakage
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C Reactive protein and sodium
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Patients without anastomotic leakage
Post operative without anastomotic leakage
|
C Reactive protein and sodium
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Early predictive factors of anastomotic leakege
Tidsramme: 2 or 3 days
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The anastomotic leak of the measurement The measurement tool is the laboratory parameters.
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2 or 3 days
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Patologiske prosesser
- Neoplasmer
- Neoplasmer etter nettsted
- Postoperative komplikasjoner
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Kolonsykdommer
- Tarmsykdommer
- Intestinale neoplasmer
- Rektale sykdommer
- Kolorektale neoplasmer
- Anastomotisk lekkasje
Andre studie-ID-numre
- 2020/13-51
Plan for individuelle deltakerdata (IPD)
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