Single Incision Plus One Port Laparoscopic Surgery Assistant Enhanced Recovery After Surgery on Colorectal Cancer
Effect of Single Incision Plus One Port Laparoscopic Surgery Assistant Enhanced Recovery After Surgery on Colorectal Cancer : A Single Arm Trial
Conventional laparoscopic surgery (CLS) for colorectal cancer has been demonstrated to be safe and feasible and present minimally invasive benefits including faster recovery, reduced postoperative pain and shorter hospital stay, also acquiring comparable oncologic outcomes with open surgery. To achieve further minimally invasive outcomes, SILS plus one port surgery was attempted by some surgeons. Preliminary results showed that SILS+1 could achieve better minimally invasive benefits than CLS while preserving oncologic feasibility.
Till now, ERAS has been practiced in colorectal cancer surgery for approximately 20 years. Studies have proven that ERAS is safe and significantly improved the recovery course of patients during perioperative period, meanwhile, the expense could be greatly reduced.
Based on ERAS studies protocols and SILS+1 trials, investigators tried to combine SILS+1 with ERAS, hopefully to provide patients with more safe, economic, feasible and rapid surgery and perioperative strategies.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
Contactos y Ubicaciones
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Primary tumor diagnosed as adenocarcinoma confirmed pathologically by endoscopic biopsy
- cT1-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition
- Located in the cecum, ascending colon, transverse colon, descending colon, sigmoid colon, the upper segment of the rectum.
- Diameter ≦ 5cm
- 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:
- Unsuitable for patients undergoing single incision plus one port laparoscopic surgery
- Patients with Complications caused by colorectal cancer ( bleeding , perforation, obstruction or incomplete obstruction )
- Previous abdominal surgery
- Malignant diseases within the past 5years
- Requirements of simultaneous surgery for another diseases
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: SILS plus one assistant ERAS
Preoperative: preadmission information, education, counseling, optimization ( breathing training), shortening fasting time and carbohydrate load Intraoperative: The intravenous fluid therapy is restricted. All patients undergo single incision plus one port laparoscopic surgery(SILS plus one). A suitable warming device (such as forced-air heating blankets) and warmed intravenous fluids are been adopted routinely to keep body temperature Postoperative: multimodal analgesia (surgical site infiltration, a nonsteroidal anti-inflammatory drug, epidural analgesia) early oral intake and move. nasogastric tubes should not be used routinely. Nasogastric tubes inserted during surgery are been removed before reversal of an aesthesia. |
SILS plus one port surgery and enhanced recovery after surgery protocol both are methods taking the minimally invasive benefits for the patients including faster recovery, reduced postoperative pain and shorter hospital stay.
Otros nombres:
|
¿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
|
The percentage of patients who met discharge criteria in the fourth day after surgery
|
4 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Medical cost
Periodo de tiempo: 1 month
|
The patient's expenses from surgery to discharge are recorded in RMB "yuan"
|
1 month
|
|
Postoperative pain score
Periodo de tiempo: Once a day from 6 hours to the fourth day after surgery
|
Postoperative pain is recorded using the visual analog scale (VAS) pain score tool on postoperative day .
On a scale of 1 to 10, the higher the score, the greater the pain.
|
Once a day from 6 hours to the fourth day after surgery
|
|
Postoperative recovery index
Periodo de tiempo: 1 month
|
The first Time to early mobilization(hour), flatus(hour), liquid diet(hour), soft diet(hour), removal of the Nasogastric tubes(hour) , removal of the peritoneal drainage(hour) are used to assess the postoperative recovery
|
1 month
|
|
Postoperative inflammatory immune response
Periodo de tiempo: 3 days
|
It includes the number of white blood cells and lymphocytes,CRP, IL-6
|
3 days
|
|
compliance with ERAS measures
Periodo de tiempo: perioperative
|
It is defined as if the patients complete every ERAS measure or not.
We can defined it "yes " or "not".
|
perioperative
|
|
6 min postoperative walking test(6MWT)
Periodo de tiempo: Once a day from the frist to the fourth day after surgery
|
Study site, subject preparation, trial procedures, and medical monitoring refer to the 6MWT guidelines issued by the American thoracic society in 2002.
|
Once a day from the frist to the fourth day after surgery
|
|
hospital readmissions
Periodo de tiempo: 30days
|
It can be defined as the number of patients readmitted within 30 days because of postoperative complications.
|
30days
|
|
Morbidity and mortality rates
Periodo de tiempo: 30 days
|
Morbidity and mortality rates are defined as postoperative complications graded according to Clavien-Dindo within 30 days.
|
30 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Wang Yannan, M.D, Nanfang Hospital of Southern Medical University
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
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
- NFEC-2019-156
Información sobre medicamentos y dispositivos, documentos del estudio
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