- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03016026
Enhanced Recovery After Surgery (ERAS) on Laparoscopy-assisted Distal Gastrectomy
Effect of Enhanced Recovery After Surgery (ERAS) on Laparoscopy-assisted Distal Subtotal Gastrectomy: A Single Arm Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Preoperative education about ERAS program is administered in the ward after admission by a specific team. Breathing training and atomizing during the time of preoperative preparation is performed during hospitalization (5-7 days). Patients are allowed to eat a normal diet and intake of 1000 ml 10% carbohydrate drink 10 hours before surgery and oral 500ml 10% carbohydrate drink 2 hours before the induction of anesthesia. Mechanical bowel preparation is not recommended as routine procedure.
The intravenous fluid therapy is restricted. Urinary catheters are routinely placed after anesthesia. In principle, drainage and nasogastric tube are not placed (except the concerns of surgical safety). Surgical site infiltration is implemented.All patients undergo laparoscopic distal gastrectomy.
Urinary catheters are routinely removed within 24 hours after operation. An optimal management of acute postoperative pain is multimodal analgesia consists of surgical site infiltration, a nonsteroidal anti-inflammatory drug for postoperative three days (POD) and epidural analgesia. Adjunctive analgesia with acetaminophen is used after the resumption of oral intake until adequate pain relief. Patients were encouraged to move from POD 1. The patients are encouraged to a full fluid diet on POD 2. Adhere to the premise of eating little and often daily increase, then to semi-fluids to soft diet. A normal diet is often started on POD 4. Abdominal drains are routinely removed within 72 hours after operation.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Guangdong
-
Guangzhou, Guangdong, Porcelana, 510-515
- Reclutamiento
- Nanfang Hospital, Southern Medical University
-
Contacto:
- Yu Zhu, M.D.
- Número de teléfono: +86-135-6022-0055
- Correo electrónico: 283934099@qq.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age from over 18 to under 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT1-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition
- Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy
- no severe organ dysfunction
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) score class I or II
- Written informed consent
Exclusion Criteria:
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
- History of other malignant disease within past five years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within past six months
- History of cerebrovascular accident within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1<50% of predicted values
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: ERAS
Preoperative education,breathing training and atomizing during the time of preoperative preparation.Shorten fasting time and carbohydrate load.The intravenous fluid therapy is restricted.Drainage and nasogastric tube are not placed (except the concerns of surgical safety).All patients undergo laparoscopic distal gastrectomy.An optimal management of acute postoperative pain is multimodal analgesia consists of surgical site infiltration, a nonsteroidal anti-inflammatory drug for postoperative three days (POD) and epidural analgesia.Early oral take and move.
|
Undergo an ERAS program
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Postoperative hospital stays
Periodo de tiempo: 1 month
|
Days from surgery to discharge
|
1 month
|
Rehabilitative rate
Periodo de tiempo: 4 days
|
Postoperative 4 days
|
4 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Medical cost
Periodo de tiempo: 1 month
|
From surgery to discharge
|
1 month
|
Postoperative pain score
Periodo de tiempo: 4 days
|
Postoperative 4 days
|
4 days
|
Postoperative recovery index
Periodo de tiempo: 1 month
|
1 month
|
|
Postoperative inflammatory immune response
Periodo de tiempo: 4 days
|
Postoperative 4 days
|
4 days
|
Morbidity rates
Periodo de tiempo: 30 days
|
30 days
|
|
Mortality rates
Periodo de tiempo: 30 days
|
30 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Guoxin Li, MD.,Ph.D, Southern Medical University, Guangzhou,China
- Investigador principal: Kexuan Liu, MD.,Ph.D, Southern Medical University, Guangzhou,China
- Director de estudio: Hao Liu, MD.,Ph.D, Southern Medical University, Guangzhou,China
- Director de estudio: Li Zhen, MD.,Ph.D, Southern Medical University, Guangzhou,China
- Director de estudio: Xiaomin Hou, MD.,Ph.D, Southern Medical University, Guangzhou,China
- Director de estudio: Jiang Yu, MD.,Ph.D, Southern Medical University, Guangzhou,China
- Director de estudio: Yu Zhu, MD., MD.,Ph.D
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- ERAS-LAG-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .