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Effect of Oral Nutritional Supplements With Specialized Nutrients on Functional Recovery and Morbidity After Gastrointestinal Surgery

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Qué se está evaluando

Resource Support®

+ Resource Protein®

+ Placebo

Suplemento Dietético
Quiénes están siendo reclutados

De 50 a 80 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Controlado con Placebo
Intervencional
Inicio del estudio: octubre de 2007
Ver detalles del protocolo

Resumen

Patrocinador PrincipalCharite University, Berlin, Germany
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de octubre de 2007

Fecha en la que se inscribió al primer participante.

Nutritional supplementation in postoperative recovery is still debated. Functional impairment is known to develop both secondary to inflammatory processes or secondary to reduced nutritional intake (e.g. disease induced anorexia). Since major surgery represents a traumatic event, surgical patients are at increased risk of malnutrition due to starvation, activation of neuroendocrine stress axis, inflammation and the subsequent increase in metabolic rate. Gastrointestinal surgery in particular can create additional problems as it often directly affects and limits dietary intake postoperatively and these effects frequently continue after discharge. Whereas manifest malnutrition occurs in about 15% of general surgical patients and in about 40% of oncology patients, postoperative weight loss of 5 to 9% occur in all surgical patients during the first two months. Moreover studies have shown that the nutritional status generally declines in hospital and both functional and nutritional status deteriorate for two months after discharge in malnourished surgical patients. Most studies that have investigated nutritional support in the surgical setting have concentrated on perioperative or short term postoperative supplementation and focussed on in-hospital infection and complication rate. Hypothesis I: Nutritional intake is decreased after surgery which results in an impaired nutritional status which in turn is associated with a decreased functional status. Protein rich nutritional supplementation is able to reverse nutritional depletion and restore functionality. Hypothesis II: Surgical stress leads to inflammation; inflammation - in addition to reduced nutritional intake - impairs functional status and increases morbidity. Anti-inflammatory, protein rich nutritional supplementation aims to prevent inflammatory complications and therefore improves functional status and reduces morbidity. In patients with high risk for inflammation, a higher effect of anti-inflammatory oral nutrition on recovery of functional status is expected. This study aims to determine whether 4 week oral nutritional supplementation and/ or specialized nutrients is effective in restoring functional status and reducing morbidity in surgical patients.

Título OficialEffect of Oral Nutritional Supplements With Specialized Nutrients on Functional Recovery and Morbidity After Gastrointestinal Surgery
NCT00546975
Patrocinador PrincipalCharite University, Berlin, Germany
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 50 a 80 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Criterios

Inclusion Criteria: 1. Patients who are \> 50 years of age and \< 80 years 2. Patients who have signed a written Informed Consent (Appendix I) prior to admission to the study. 3. Patients who have an ECOG performance status (presurgery) of 0, 1 or 2 (Appendix II). 4. Patients able to orally consume 500 mL or more of liquid a day after adaption 5. Patients undergoing elective gastrointestinal surgery \[e.g. Colorectal surgery: colectomy, hemicolectomy, proctectomy; Small bowel resection/surgery; liver resection, splenectomy, non-whipple pancreatic surgery\] Exclusion Criteria: 1. Patients who are \> 80 years of age and \< 50 years 2. Patients who have co-morbid conditions, uncontrolled metabolic conditions or psychiatric conditions that might make tolerance or evaluation of the feeding formula difficult; 3. Patients undergoing Whipple´s procedure, gastrectomy, oesophageal resection 4. Patients who get preoperative nutritional support 5. Patients taking supplements (EPA, DHA) 6. Any concomitant severe disease e.g. * Patients with respiratory failure (FEV\<0.8l/sec) * Patients with renal failure (Cr \> 3mg/dl or dialysis patients) * Patients with hepatic dysfunction (Child \>A) * Patients with cardiac failure (NYHA \> III) 7. Patients suffering from an intestinal obstruction or ileus 8. Patients with an Hb level of \>8 g/dL experiencing gastrointestinal haemorrhaging 9. Patients with HIV 10. Patients requiring immunosuppression treatments 11. Pregnancy 12. Patients undergoing emergency surgery 13. Other patients determined by a study investigator to be inappropriate for enrolment in this study

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

3 grupos de intervención están designados en este estudio

33.333333333333336% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Resource Support® Novartis

Grupo II

Comparador Activo
Resource Protein®, Novartis

Grupo III

Placebo

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

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Este estudio tiene una ubicación

Suspendido

Dept of Surgery CCM

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Suspendido1 Centros de Estudio