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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
50
same as above as described in the "arms".
The Chinese Universtiy of Hong Kong
Hong Kong, Hong Kong
RECRUITINGPost-operative hospital stay
The number of days patient stays in hospital after the surgery
Time frame: Within 30 days
Serum lymphocyte counts
This is used to assess the patient's immunological status after the surgery.
Time frame: Within 5 days of the surgery
Post-operative pain scores
Pain scores on visual analogue scale (from 0 that implies no pain at all, to 100 which implies the worst pain imaginable) assessed daily from day 0 onwards till discharge. Pain assessments will be conducted after patients have been in a resting supine position for 5 minutes and then repeated after coughing for ten times.
Time frame: Within 2 weeks
Forced vital capacity
This will be done in terms of peak flow rate at bedside.
Time frame: Within 2 weeks
Mortality and morbidity
The morbidities would be recorded according to predefined criterion. Mortalities within 30 days would be included.
Time frame: Within 30 days
Readmission rate
Readmission of more than 24 hours would be counted as readmission
Time frame: Within 30 days
Quality of life assessments
This will be measured by European organisation for Research and Treatment of Cancer (EORTC)-stomach questionnaires
Time frame: within 4 weeks
Direct hospital costs
All costs involving the admission and readmissions
Time frame: within 30days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.