Enhanced Recovery After Surgery for Laparoscopic Gastrectomy for Patients With Gastric Cancer
Conditions
Keywords
Enhanced recovery after surgery, ERAS, Fast track recovery, Laparoscopic gastrectomy, Gastric Cancer
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.
Interventions
same as above as described in the arms.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
This is a randomised controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative hospital stay | Within 30 days | The number of days patient stays in hospital after the surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain scores | Within 2 weeks | 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. |
| Forced vital capacity | Within 2 weeks | This will be done in terms of peak flow rate at bedside. |
| Mortality and morbidity | Within 30 days | The morbidities would be recorded according to predefined criterion. Mortalities within 30 days would be included. |
| Serum lymphocyte counts | Within 5 days of the surgery | This is used to assess the patient's immunological status after the surgery. |
| Quality of life assessments | within 4 weeks | This will be measured by European organisation for Research and Treatment of Cancer (EORTC)-stomach questionnaires |
| Direct hospital costs | within 30days | All costs involving the admission and readmissions |
| Readmission rate | Within 30 days | Readmission of more than 24 hours would be counted as readmission |
Countries
Hong Kong
Contacts
Primary ContactShannon M Chan, MBCHB, FRCS
Backup ContactAnthony YB Teoh, MBCHB, FRCS
Outcome results
None listed