Clinical trial NCT03160924: The Impact of Enhanced Recovery After Surgery (ERAS) Program on Clinical and Immunological Outcomes for Minimally-invasive Gastrectomy
Official title: The Impact of Enhanced Recovery After Surgery (ERAS) Program on Clinical and Immunological Outcomes for Minimally-invasive Gastrectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Enhanced Recovery After Surgery for Laparoscopic Gastrectomy for Patients With Gastric Cancer
Keywords: Enhanced recovery after surgery
ERAS
Fast track recovery
Laparoscopic gastrectomy
Gastric Cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomised controlled study
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Preoperative chemotherapy or radiotherapy
2. Known metastatic disease
3. Previous history of midline laparotomy
4. Gastric outlet obstruction
5. Known immunological dysfunction (e.g. HIV infection)
6. Patients on steroids or immunosuppressive agents, patients with chronic pain syndrome and patients with chronic renal or liver disease
7. 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:

1. Intraoperative blood loss \>= 500ml
2. Prolonged operation \>6hrs
3. Gastrectomy not proceeded due to presence of peritoneal metastasis Concomitant resection of organs other than the gallbladder, eg. spleen, bowel

Primary outcomes:
measure: Post-operative hospital stay
timeFrame: Within 30 days
Secondary outcomes:
measure: Serum lymphocyte counts
timeFrame: Within 5 days of the surgery
measure: Post-operative pain scores
timeFrame: Within 2 weeks
measure: Forced vital capacity
timeFrame: Within 2 weeks
measure: Mortality and morbidity
timeFrame: Within 30 days
measure: Readmission rate
timeFrame: Within 30 days
measure: Quality of life assessments
timeFrame: within 4 weeks
measure: Direct hospital costs
timeFrame: within 30days
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese Universtiy of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Shannon M Chan, MBCHB, FRCS
role: PRINCIPAL_INVESTIGATOR
References: