- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02084524
ANC1 Study Impact of a Geriatric and Nutritional Evaluation for the Malnutrition and Malnutrition Risk Screening in Patients Over 70 Years With Colorectal Surgery. (ANC1)
Malnutrition priori a major abdominal surgery is frequent and increases morbidity and mortality. The management of malnutrition has an impact in reducing postoperative complications. However malnutrition is rarely detected and Guidelines infrequently followed.
Recovery time and nutritional evaluation in elderly patients are major criteria in their postoperative management. Identifying malnutrition or malnutrition risk is fundamental to its treatment. It is therefore unsurprising that many validated tools for nutrition risk screening and nutrition assessment exist for the clinician to use in assisting with the accurate identification, referral and treatment of patients who are malnourished or at risk of malnutrition.
And nutritional management must be adapted and based on this evaluation and evolution of the general status (Guidelines Grade A).
A geriatric evaluation based on a screening of preoperative malnutrition should allow a better implementation of the European Society of Parenteral and Enteral Nutrition (ESPEN) guidelines.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
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Pierre Benite, France, 69495
- Recrutement
- Professeur Marc BONNEFOY
-
Contact:
- Laurent VILLENEUVE
- Numéro de téléphone: 04 788 645 36
- E-mail: laurent.villeneuve@chu-lyon.fr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Aged ≥ 70 years
- Colorectal or tumor resection with/without synchronous metastases
Exclusion Criteria:
- Emergency resection of colorectal tumor
- Unresectable colorectal tumor with/without synchronous metastases
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Dépistage
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Nutritional evaluation
|
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Perioperative nutritional management
Délai: During perioperative period From D-7 before date of hospitalization until discharge from the hospital, up to 30 days
|
Rate of nutritional support implemented in accordance with current European guidelines (ESPEN)
|
During perioperative period From D-7 before date of hospitalization until discharge from the hospital, up to 30 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Malnutrition screening
Délai: During preoperative seven days
|
Rate of malnutrition screening procedure
|
During preoperative seven days
|
|
Rate of preoperative nutritional management by immunonutrition implemented
Délai: During preoperative seven days
|
Nutritional management by immunonutrition implemented is based on a complete nutritional evaluation
|
During preoperative seven days
|
|
Rate of malnourished patients
Délai: During preoperative seven days
|
Rate of malnourished patients is defined by the ESPEN criteria
|
During preoperative seven days
|
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Rate of patients with cachexia
Délai: Seventh day preoperative
|
Rate of patients with cachexia is defined by the French National Authority for Health (HAS) criteria
|
Seventh day preoperative
|
|
Postoperative complications
Délai: Postoperative follow-up until discharge from hospital, up to 30 days
|
Rate and type of postoperative complications (Grade I, II et IIIa of Dindo classification)
|
Postoperative follow-up until discharge from hospital, up to 30 days
|
|
Rate of postoperative nutritional management implemented
Délai: Postoperative follow-up until discharge from hospital, up to 30 days
|
Nutritional management implemented is based on the ESPEN guidelines
|
Postoperative follow-up until discharge from hospital, up to 30 days
|
|
Evolution of the activities of daily living
Délai: During preoperative seven days and postoperative follow-up until discharge from hospital, up to 30 days
|
Variations of Activities of daily living (ADL) and Instrumental activities of daily living (IADL) scores
|
During preoperative seven days and postoperative follow-up until discharge from hospital, up to 30 days
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2011.703
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