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临床试验/NCT03160924
NCT03160924Unknown3 期

The Impact of Enhanced Recovery After Surgery (ERAS) Program on Clinical and Immunological Outcomes for Minimally-invasive Gastrectomy: A Randomized Controlled Trial

Chinese University of Hong Kong2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
3 期
入组人数
50
试验地点
2
主要终点
Post-operative hospital stay

研究概览

简要总结

Over the past two decades, fast track surgery, also known as "enhanced recovery after surgery (ERAS)" has been initiated and developed in colorectal surgery by Kehlet. The program is rapidly gaining popularity due to the significant benefits demonstrated in lowering complication rates and reducing hospital stay and costs. The benefits demonstrated in colorectal surgery by randomized trials and meta-analyses reduced pain, morbidity and hospital stay. Data in gastrectomy however, is scarce. Therefore the aim of this study is to compare the outcomes of laparoscopic gastrectomies with two different perioperative approaches, the traditional and the ERAS approach in a setting of a randomised controlled trial.

详细描述

Over the past two decades, fast track surgery, also known as "enhanced recovery after surgery (ERAS)" has been initiated and developed in colorectal surgery by Kehlet. The program is rapidly gaining popularity due to the significant benefits demonstrated in lowering complication rates and reducing hospital stay and costs. The benefits demonstrated in colorectal surgery by randomized trials and meta-analyses reduced pain, morbidity and hospital stay. Data in gastrectomy however, is scarce. Therefore the aim of this study is to compare the outcomes of laparoscopic gastrectomies with two different perioperative approaches, the traditional and the ERAS approach in a setting of a randomised controlled trial.

ERAS involves an integrated multi-disciplinary program of various medical interventions involving surgeons, anaesthetists, physiotherapists, dieticians and nurses, aiming at enhancing postoperative recovery by reducing surgical stress response resulting in earlier discharge and potentially reduced morbidities. The program focuses on minimising the impact of surgery on patients' homeostasis. The reduction of postoperative physiological stress by the attenuation of the neurohormonal response to the surgical intervention not only provides the basis for a faster recovery, but also diminishes the risk of organ dysfunction and complications. The ERAS program consists of well-organised pathways of clinical interventions that begin from out-patient preoperative information, counselling and physical optimization, proceeding to pre-, intra- and postoperative protocol-driven actions and end with patient discharge following pre-established criteria. The main pillars of ERAS program consist of extensive preoperative counselling, non sedative premedication, no preoperative fasting but with pre-operative carbohydrate loading, tailored anaesthesiology, peri-operative intravenous fluid restriction, non-opioid pain management, non routine use of nasogastric tubes, early removal of urinary catheter, and early postoperative feeding and mobilization.

ERAS program will be implemented in one arm and the other arm would be conventional peri-operative care. This is a randomised controlled study. Apart from clinical outcomes, the immunological outcomes will also be assessed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consecutive patients undergoing elective gastrectomy with the minimally-invasive approach
  • Aged between 18 and 75 years
  • American Society of Anesthesiologists (ASA) grading I-II
  • No severe physical disability
  • Patients who require no assistance with the activities of daily living
  • Informed consent available.

排除标准

  • Preoperative chemotherapy or radiotherapy
  • Known metastatic disease
  • Previous history of midline laparotomy
  • Gastric outlet obstruction
  • Known immunological dysfunction (e.g. HIV infection)
  • Patients on steroids or immunosuppressive agents, patients with chronic pain syndrome and patients with chronic renal or liver disease
  • Patients who are pregnant and mentally incapable of consent
  • Post-randomization exclusion criteria:
  • Since the operation itself is a determinant to postoperative course and management, the withdrawal criteria were established as follows:
  • Intraoperative blood loss >= 500ml
  • Prolonged operation >6hrs
  • Gastrectomy not proceeded due to presence of peritoneal metastasis Concomitant resection of organs other than the gallbladder, eg. spleen, bowel

结局指标

主要结局

Post-operative hospital stay

时间窗: Within 30 days

The number of days patient stays in hospital after the surgery

次要结局

  • Serum lymphocyte counts(Within 5 days of the surgery)
  • Post-operative pain scores(Within 2 weeks)
  • Forced vital capacity(Within 2 weeks)
  • Mortality and morbidity(Within 30 days)
  • Readmission rate(Within 30 days)
  • Quality of life assessments(within 4 weeks)
  • Direct hospital costs(within 30days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

CHAN SHANNON MELISSA

Resident Specialist

Chinese University of Hong Kong

研究点 (2)

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