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

Phase 3

• Conditions: Enhanced Recovery After Surgery for Laparoscopic Gastrectomy for Patients With Gastric Cancer
• Interventions: Other: Enhanced Recovery After Surgery (ERAS)

• Registration Number: NCT03160924
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study Start: 2016-12-01
• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-17
• Study First Posted: 2017-05-19
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-20
• Last Update Posted: 2020-05-22
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Recovery After Surgery (ERAS)	Enhanced Recovery After Surgery (ERAS)	In this arm, the ERAS perioperative care program will be applied. 1. Preoperative counselling by surgeon, dietician and physiotherapist 2. Preoperative carbohydrate-loaded drink 800ml 12.5% Carbohydrate drink 8h before surgery 400ml 12.5% Carbohydrate drink 4h before surgery (Omit 4h drink if patient has DM) 3. Fluid restriction, avoid opioids, use of Cox-II inhibitors as analgesics 4. Avoid use of drains 5. Early resumption of diet 6. Early mobilisation with physiotherapist 7. Dietary counselling by dietician 8. Early discharge if fulfil discharge criteria. Discharge criteria: Adequate pain control with oral analgesics Ability to tolerate soft diet Passage of flatus Mobilization Patients will be called by doctors every day after discharge to monitor their clinical status. There will be a low threshold for readmitting patients. Patients will also be given a hotline to call if they feel unwell. They will be seen in clinic on post-operative D7 and D14.

Primary Outcome Measures

Name	Time	Method
Post-operative hospital stay	Within 30 days	The number of days patient stays in hospital after the surgery

Secondary Outcome Measures

Name	Time	Method
Serum lymphocyte counts	Within 5 days of the surgery	This is used to assess the patient's immunological status after the surgery.
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.
Readmission rate	Within 30 days	Readmission of more than 24 hours would be counted as readmission
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

Trial Locations

Locations (1)

The Chinese Universtiy of Hong Kong; 🇭🇰 Hong Kong, Hong Kong