Enhanced Recovery After Surgery for Laparoscopic Gastrectomy for Patients With Gastric CancerPhase 3NCT03160924
The Impact of Enhanced Recovery After Surgery (ERAS) Program on Clinical and Immunological Outcomes for Minimally-invasive Gastrectomy
A Phase 3 study testing Enhanced Recovery After Surgery (ERAS) in people with Enhanced Recovery After Surgery for Laparoscopic Gastrectomy for Patients With Gastric Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Enhanced Recovery After Surgery for Laparoscopic Gastrectomy for Patients With Gastric Cancer
- What is being tested?
- Enhanced Recovery After Surgery (ERAS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2016to 31 May 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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:
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese Universtiy of Hong Kong
Hong Kong, 00000
Shannon M Chan, MBCHB, FRCS, 35052627, shannonchan@surgery.cuhk.edu.hk
Anthony YB Teoh, MBCHB, FRCS, 35052627, anthonyteoh@surgery.cuhk.edu.hk
About this study
Official title: The Impact of Enhanced Recovery After Surgery (ERAS) Program on Clinical and Immunological Outcomes for Minimally-invasive Gastrectomy: A Randomized 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.
Read the 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.
- Conditions
- Enhanced Recovery After Surgery for Laparoscopic Gastrectomy for Patients With Gastric Cancer
- Being tested
- Enhanced Recovery After Surgery (ERAS)
- Keywords
- Enhanced recovery after surgery, ERAS, Fast track recovery, Laparoscopic gastrectomy, Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery After Surgery (ERAS)Other
same as above as described in the "arms".
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Recovery After Surgery (ERAS) | Active comparator | 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. Receives: Other: Enhanced Recovery After Surgery (ERAS) |
| Conventional perioperative program | No intervention | In 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative hospital stay
The number of days patient stays in hospital after the surgery
Measured: Within 30 days
Secondary outcomes (7)
Serum lymphocyte counts
This is used to assess the patient's immunological status after the surgery.
Measured: 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.
Measured: Within 2 weeks
Forced vital capacity
This will be done in terms of peak flow rate at bedside.
Measured: Within 2 weeks
Mortality and morbidity
The morbidities would be recorded according to predefined criterion. Mortalities within 30 days would be included.
Measured: Within 30 days
Readmission rate
Readmission of more than 24 hours would be counted as readmission
Measured: Within 30 days
Quality of life assessments
This will be measured by European organisation for Research and Treatment of Cancer (EORTC)-stomach questionnaires
Measured: within 4 weeks
Direct hospital costs
All costs involving the admission and readmissions
Measured: within 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start1 Dec 2016
- Primary completion31 May 2021 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhanced Recovery After Surgery for Laparoscopic Gastrectomy for Patients With Gastric CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomised controlled study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHAN SHANNON MELISSA, Chinese University of Hong Kong
- Investigators
- Shannon M Chan, MBCHB, FRCS, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160924
- Sponsor's protocol ID
- CRE2015.530
- Status last verified
- May 2020
- First submitted
- 15 May 2017
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data of the patients will only be available to researches participating in this study.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Enhanced Recovery After Surgery (ERAS) Program on Clinical and Immunological Outcomes for Minimally-invasive Gastrectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03160924
- Acronym / sponsor ID
- CRE2015.530
- Conditions
- Enhanced Recovery After Surgery for Laparoscopic Gastrectomy for Patients With Gastric Cancer
- Keywords
- Enhanced recovery after surgery, ERAS, Fast track recovery, Laparoscopic gastrectomy, Gastric Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomised controlled study
| Arm | Type | Receives |
|---|---|---|
| Enhanced Recovery After Surgery (ERAS) | Active comparator | Other: 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. |
| Conventional perioperative program | No intervention | –In 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- Preoperative chemotherapy or radiotherapy
- Known metastatic disease
- Previous history of midline laparotomy
- Gastric outlet obstruction
- Known immunological dysfunction (e.g. HIV infection)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Recovery After Surgery (ERAS)same as above as described in the "arms". | Other | Enhanced Recovery After Surgery (ERAS) |
Primary outcome
Post-operative hospital stay
Time frame: Within 30 days
The number of days patient stays in hospital after the surgery
7 secondary outcomes
Serum lymphocyte counts
Time frame: Within 5 days of the surgery
Post-operative pain scores
Time frame: Within 2 weeks
Forced vital capacity
Time frame: Within 2 weeks
Mortality and morbidity
Time frame: Within 30 days
Readmission rate
Time frame: Within 30 days
Quality of life assessments
Time frame: within 4 weeks
Direct hospital costs
Time frame: within 30days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
- Individual participant dataSharing planned: No. The data of the patients will only be available to researches participating in this study.
Related trials for Enhanced Recovery After Surgery for Laparoscopic Gastrectomy for Patients With Gastric Cancer
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Peri-habilitation for Patients With Gastric Cancer
Gastric Cancer (Diagnosis), Gastric Cancer Patient
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon M Chan, MBCHB, FRCS principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enhanced Recovery After Surgery (ERAS) in people with Enhanced Recovery After Surgery for Laparoscopic Gastrectomy for Patients With Gastric Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shannon M Chan, MBCHB, FRCS (35052627, shannonchan@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative hospital stay (time frame: Within 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2020.