- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
- 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).
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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İzmir, Tacchino, 35180
- Tepecik Training and Research Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Patients with anastomotic leakage
Post operative anastomotic leakage
|
C Reactive protein and sodium
|
|
Patients without anastomotic leakage
Post operative without anastomotic leakage
|
C Reactive protein and sodium
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Early predictive factors of anastomotic leakege
Lasso di tempo: 2 or 3 days
|
The anastomotic leak of the measurement The measurement tool is the laboratory parameters.
|
2 or 3 days
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Processi patologici
- Neoplasie
- Neoplasie per sede
- Complicanze postoperatorie
- Neoplasie gastrointestinali
- Neoplasie dell'apparato digerente
- Malattie gastrointestinali
- Malattie del colon
- Malattie intestinali
- Neoplasie intestinali
- Malattie del retto
- Neoplasie colorettali
- Perdita anastomotica
Altri numeri di identificazione dello studio
- 2020/13-51
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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