The Impact of Enhanced Recovery After Surgery (ERAS) Program on Clinical and Immunological Outcomes for Minimally-invasive Gastrectomy
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2016
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 15, 2017
CompletedFirst Posted
Study publicly available on registry
May 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2021
CompletedMay 22, 2020
May 1, 2020
4.5 years
May 15, 2017
May 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-operative hospital stay
The number of days patient stays in hospital after the surgery
Within 30 days
Secondary Outcomes (7)
Serum lymphocyte counts
Within 5 days of the surgery
Post-operative pain scores
Within 2 weeks
Forced vital capacity
Within 2 weeks
Mortality and morbidity
Within 30 days
Readmission rate
Within 30 days
- +2 more secondary outcomes
Study Arms (2)
Enhanced Recovery After Surgery (ERAS)
ACTIVE COMPARATORIn 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.
Conventional perioperative program
NO INTERVENTIONIn this arm, the conventional preoperative program will be applied. 1. No preoperative counselling 2. No Preoperative carbohydrate-loaded drink 3. Routine anaesthesia, no specific protocol on fluid restriction, opioids will be used as usual. Tramadol would be used as postoperative pain control. 4. Routine use of drains 5. Diet will be resumed when there is flatus clinically 6. Mobilisation as per patient's wish 7. Dietary counselling by dietician 8. 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 seen in clinic on post-operative D14.
Interventions
same as above as described in the "arms".
Eligibility Criteria
You may qualify if:
- Consecutive patients undergoing elective gastrectomy with the minimally-invasive approach
- Aged between 18 and 75 years
- American Society of Anesthesiologists (ASA) grading I-II
- No severe physical disability
- Patients who require no assistance with the activities of daily living
- Informed consent available.
You may not qualify if:
- Preoperative chemotherapy or radiotherapy
- Known metastatic disease
- Previous history of midline laparotomy
- Gastric outlet obstruction
- Known immunological dysfunction (e.g. HIV infection)
- Patients on steroids or immunosuppressive agents, patients with chronic pain syndrome and patients with chronic renal or liver disease
- Patients who are pregnant and mentally incapable of consent
- Since the operation itself is a determinant to postoperative course and management, the withdrawal criteria were established as follows:
- Intraoperative blood loss \>= 500ml
- Prolonged operation \>6hrs
- Gastrectomy not proceeded due to presence of peritoneal metastasis Concomitant resection of organs other than the gallbladder, eg. spleen, bowel
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Chinese Universtiy of Hong Kong
Hong Kong, 00000, Hong Kong
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shannon M Chan, MBCHB, FRCS
Chinese University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident Specialist
Study Record Dates
First Submitted
May 15, 2017
First Posted
May 19, 2017
Study Start
December 1, 2016
Primary Completion
May 31, 2021
Study Completion
May 31, 2021
Last Updated
May 22, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share
The data of the patients will only be available to researches participating in this study.