- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03070626
Preoperative Loading With Carbohydrates in Lung Cancer Surgery
Administration of preoperative oral carbohydrates are suggested to reduce insulin resistance due to surgical stress.
The aim of this study is to investigate whether preoperative oral carbohydrate loading can contribute to lower incidence of postoperative discomfort and to reduce complications in elective lung cancer patients undergoing video assisted thorascopic surgery (VATS).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Fasting from 6-12hours before elective surgery is still standard of care in many departements, including our departement in Oslo University Hospital.
Surgery is a trauma that triggers a catabolic stress response with high emissions of hormones and immune activation. These activations can affect brain, heart, muscles and liver. The metabolic changes may in addition influence development of pain, tissue damage, ileus, tachycardia and other hemodynamic disturbances. Preoperative fasting has shown an increase of surgical stress and to impact catabolic processes which secondarily may lead to insulin resistance and hyperglycemia in non-diabetic patients. Insulin resistance and hyperglycaemia are known to increase the incidence of postoperative infections. Previous studies have also shown that prolonged fasting increases the incidence of gastrointestinal problems. A 12 hour fast before surgery has shown delayed recovery.
Studies have shown that patients undergoing lung cancer surgery suffer from multiple symptoms and experience discomfort in the postoperative phase. Symptoms include dyspnea, fatigue, pain, weakness, cough, dry mouth, nervousness, difficulty sleeping, stomach-/intestinal-problems and lack of appetite. Carbohydrate-rich supplements have shown a positive effect on other perioperative symptoms and measures, but is to our knowledge currently not investigated in lung cancer surgery.
Therefore, there is a need to explore the possible advantages of preoperative oral carbohydrate loading in lung cancer surgery.
The primary aim of this study is to investigate whether preoperative carbohydrate loading with PreOp® provides less postoperative discomfort in the early postoperative phase measured by Quality of Recovery-40 (QoR-40), a validated and widely used measure of quality of recovery.
The secondary aim is to investigate if preoperative loading with carbohydrates affect the incidence of postoperative complications such as stomach-/intestinal problems and heart rhythm disorder, in addition to contribute to faster mobilization and to reduce hospital length of stay.
This study may provide important data regarding the lung cancer patients perioperative symptoms, complications and well-being when using a carbohydrate-rich supplement as intervention to standard of care.
In this study, the intervention group will be given 800ml of a oral carbohydrate supplement, PreOp®, the night before surgery and 400ml of the same supplement, PreOp®, 2-4 hours prior to surgery. The control group will be fasted from 24h, the night before surgery, in accordance to the departements standard of care.
Both groups, the interventional and the control group, will follow the department's perioperative course with regard to anesthetic and surgical procedures.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Per Reidar Woldbæk, MD, PhD
- Número de teléfono: +4798895427
- Correo electrónico: UXPEWO@ous-hf.no
Copia de seguridad de contactos de estudio
- Nombre: Astrid B. Krohn-Hansen, bachelor
- Número de teléfono: +4792270669 +4723015453
- Correo electrónico: astkro@ous-hf.no
Ubicaciones de estudio
-
-
-
Oslo, Noruega, 0450
- Reclutamiento
- Oslo University Hospital
-
Contacto:
- Per Reidar Woldbaek, MD, PhD
- Número de teléfono: +4798895427
- Correo electrónico: uxpewo@ous-hf.no
-
Contacto:
- Astrid Krohn-Hansen, RN
- Número de teléfono: +4792270669
- Correo electrónico: astkro@ous-hf.no
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
adult patients undergoing elective video-assisted thoracoscopic surgery due to lung neoplasms.
- ability to understand and speak Norwegian
Exclusion Criteria:
- impaired gastric emptying
- diabetes
- ongoing treatment for pain
- ongoing infection
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Interventional group
Carbohydrate-rich, dietary supplement: PreOp® 800ml day before surgery and PreOp® 400ml 2-4hours preoperative.
|
No preoperative drink.
Otros nombres:
|
Sin intervención: Control group
Standard of care: Fasting from 24hours (midnight), night before surgery.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Postoperative discomfort measured by the questionnaire "Quality of recovery 40" (QoR-40) measured on the first postoperative day.
Periodo de tiempo: First postoperative day
|
Postoperative discomfort measured by the questionnaire "Quality of recovery 40" (QoR-40) measured on the first postoperative day.
|
First postoperative day
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Gastrointestinal discomfort postoperatively.
Periodo de tiempo: First seven postoperative days.
|
Number of patients experiencing nausea, vomiting, diarrhea and/or obstipation.
|
First seven postoperative days.
|
Heart rhythm disturbances postoperatively.
Periodo de tiempo: First seven postoperative days.
|
Number of patients with arrhythmia lasting more than 5 min or treated with antiarrhythmic agents.
|
First seven postoperative days.
|
Time to mobilization.
Periodo de tiempo: First seven postoperative days.
|
Time to mobilization out of bed (to chair or walking) as registered by the attending nurse.
|
First seven postoperative days.
|
Length of stay
Periodo de tiempo: First seven postoperative days.
|
Length of hospital stay to discharge for index admission.
|
First seven postoperative days.
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2016/2020
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre PreOp®
-
Insel Gruppe AG, University Hospital BernReclutamientoColonización Microbiana | Dieta, SaludableSuiza
-
Karolinska InstitutetTerminadoSensibilidad a la insulinaSuecia
-
Medical University of GdanskDesconocido
-
Fresenius KabiTerminadoNutrición Enteral (Alimento para Fines Médicos Especiales)Italia
-
University of Milano BicoccaUniversity of Pavia; European Institute of Oncology; University of Siena; San Raffaele...Terminado
-
Brugmann University HospitalReclutamiento
-
Uppsala UniversityKarolinska InstitutetTerminadoFractura de cadera | Gastroparesia | Nutrición insuficiente leve
-
Fresenius KabiTerminadoTumores rectalesPaíses Bajos
-
Pomeranian Medical University SzczecinDesconocidoNáuseas y vómitos postoperatoriosPolonia
-
University of NottinghamTerminado