- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT06316245
Capacité fonctionnelle et jours de vie hors de l'hôpital à 30 jours
Évaluation des jours en vie et hors hôpital à 30 jours chez les patients ayant une capacité fonctionnelle faible ou bonne subissant une chirurgie gastro-intestinale
This prospective observational study aims to compare days alive and out of hospital at 30 days (DAOH-30) in patients with poor or good functional capacity undergoing gastrointestinal surgeries. The investigators are testing the hypothesis that patients with good functional capacity will have longer days alive and out of hospital than those with poor.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Days Alive and Out of Hospital (DAOH) is a composite patient-centered outcome that integrates three critical clinical outcomes: death, hospital length of stay, and hospital readmission. It is associated with patient comorbidities, surgical complexity, and postoperative complications.
Evaluation of functional capacity before noncardiac surgery is recommended to identify the perioperative risks. Duke Activity Status Index (DASI) is one of the tools for determining functional capacity; the scores are between 0 and 58,2, and high scores are related to improved capacity. A DASI score of 34 and below was found to be a risk for moderate to severe complications and new disability.
The primary aim is to compare days alive and out of the hospital at 30 days in patients ≤ 34 and above 34 DASI scores. The secondary aims are to evaluate intensive care unit (ICU) need and duration, length of hospital stay, rehospitalization, postoperative complications, morbidity, and mortality in patients with DASI scores ≤ 34 and above 34. Days alive and out of hospital at 90 days will be compared in both groups as a secondary outcome. The investigators will also analyze the possible perioperative factors affecting the days alive and out of the hospital outcome.
Before the operation, the patients will answer the DASI questionnaire in the waiting area of the operating theatres. The patients will be divided into two groups according to the DASI score (Poor functional capacity: ≤ 34 points, good functional capacity: above 34 points).
Patient and surgical characteristics (comorbidities, American Society of Anesthesiologists physical status classification, laboratory values before the operation, frailty index value, American College of Surgeons Risk Calculator outcomes, surgery type, length of operation, intraoperative complications), ICU need and duration will be recorded. Postoperative complications ( cardiovascular, pulmonary, renal, neurologic, surgical, infectious, and wound ), the Postoperative Morbidity Survey (POMS) related morbidity and mortality on the 30th day will be investigated. Length of hospital stay starting with index surgery, rehospitalization and duration of further stays will be recorded. Days Alive and Out of Hospital at 30 days (DAOH-30) will be calculated using mortality, hospital length of stay, and readmissions between the date of the index surgery and the 30th postoperative day. 90th-day mortality and Days Alive and Out of Hospital at 90 days (DAOH-90) will also be investigated.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
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Fatih
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Istanbul, Fatih, Turquie (Türkiye), 34093
- Istanbul University Istanbul Medical Faculty, Department of Anesthesiology and Reanimation
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Patients undergoing gastrointestinal surgeries at Istanbul Medical Faculty in Istanbul-Turkey will be selected for the study population. Istanbul Medical Faculty is a tertiary center university hospital with approximately 25.000 surgeries annually.
La description
Inclusion Criteria:
- Patients undergoing intermediate and major upper or lower gastrointestinal surgeries (small intestine, colon, rectal, gastric, esophagus) with a predicted hospital stay of more than 24 hours
- Patients aged 18 and above
- Signed written informed consent
- Reaching all perioperative data
Exclusion Criteria:
- Day case/ambulatory or one overnight hospital stay for minor gastrointestinal and perianal surgeries (hernia repair, hemorrhoidectomy, perianal abscess and fistula, appendectomy)
- Hepatobiliary surgeries (hepatectomy, pancreas and gallbladder surgeries)
- Patients aged below 18
- Not signed written informed consent
- Missing perioperative data
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Group DASI ≤ 34
Patients with Duke Activity Status Index (DASI) scores are ≤ 34 before the surgery. |
All patients will answer the DASI questionnaire before surgery. According to their scores, they will be divided into two groups. A score of 34 and below will be considered poor, and above 34 will be considered to have good functional capacity. |
|
Group DASI > 34
Patients with Duke Activity Status Index (DASI) scores are > 34 before the surgery. |
All patients will answer the DASI questionnaire before surgery. According to their scores, they will be divided into two groups. A score of 34 and below will be considered poor, and above 34 will be considered to have good functional capacity. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Days alive and out of hospital at 30 days (DAOH-30)
Délai: 30 days
|
It is calculated using mortality, hospital length of stay, and readmissions between the date of the index surgery and the 30th postoperative day. |
30 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Days alive and out of hospital at 90 days (DAOH-90)
Délai: 90 days
|
It is calculated using mortality, hospital length of stay, and readmissions between the date of the index surgery and the 90th postoperative day. |
90 days
|
|
Postoperative complications
Délai: 30 days
|
Cardiovascular, pulmonary, renal, neurologic, surgical, infectious and wound complications |
30 days
|
|
The Postoperative Morbidity Survey (POMS) defined morbidity
Délai: 30 days
|
Pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, hematological, wound complications and pain will be examined according to POMS |
30 days
|
|
Mortality
Délai: 30 days and 90 days
|
In and out of hospital mortality |
30 days and 90 days
|
|
Intensive care unit (ICU) stay
Délai: 30 days
|
Duration of ICU stay (days) |
30 days
|
|
Length of hospital stay after index surgery
Délai: 30 days
|
Length of first hospital stay starting with index surgery (days) |
30 days
|
|
Rehospitalization
Délai: 30 days and 90 days
|
Readmission and hospitalization after first discharge |
30 days and 90 days
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Muserref B Dincer, Istanbul University, Istanbul Medical Faculty, Department Anesthesiology and Reanimation
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2024/178
Informations sur les médicaments et les dispositifs, documents d'étude
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