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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Recovery After Surgery (ERAS) | Active Comparator | In this arm, the ERAS perioperative care program will be applied.
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. |
|
| Conventional perioperative program | No Intervention | In this arm, the conventional preoperative program will be applied.
Discharge criteria: Adequate pain control with oral analgesics Ability to tolerate soft diet Passage of flatus Mobilization Patients will be seen in clinic on post-operative D14. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Recovery After Surgery (ERAS) | Other | same as above as described in the "arms". |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative hospital stay | The number of days patient stays in hospital after the surgery | Within 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Serum lymphocyte counts | This is used to assess the patient's immunological status after the surgery. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Post-randomization exclusion criteria:
Since the operation itself is a determinant to postoperative course and management, the withdrawal criteria were established as follows:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shannon M Chan, MBCHB, FRCS | Contact | 35052627 | shannonchan@surgery.cuhk.edu.hk | |
| Anthony YB Teoh, MBCHB, FRCS | Contact | 35052627 | anthonyteoh@surgery.cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Shannon M Chan, MBCHB, FRCS | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese Universtiy of Hong Kong | Recruiting | Hong Kong | 00000 | Hong Kong |
The data of the patients will only be available to researches participating in this study.
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This is a randomised controlled study
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| Within 2 weeks |
| Forced vital capacity | This will be done in terms of peak flow rate at bedside. | Within 2 weeks |
| Mortality and morbidity | The morbidities would be recorded according to predefined criterion. Mortalities within 30 days would be included. | Within 30 days |
| Readmission rate | Readmission of more than 24 hours would be counted as readmission | Within 30 days |
| Quality of life assessments | This will be measured by European organisation for Research and Treatment of Cancer (EORTC)-stomach questionnaires | within 4 weeks |
| Direct hospital costs | All costs involving the admission and readmissions | within 30days |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D000080482 | Enhanced Recovery After Surgery |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D013514 | Surgical Procedures, Operative |
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