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

NCT ID: NCT03160924

Last Updated: 2020-05-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-01
• Study Completion Date: 2021-05-31

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.

Conditions

Enhanced Recovery After Surgery for Laparoscopic Gastrectomy for Patients With Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Enhanced Recovery After Surgery (ERAS)

Intervention Type: OTHER

same as above as described in the "arms".

Conventional perioperative program

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Enhanced Recovery After Surgery (ERAS)

same as above as described in the "arms".

Intervention Type: OTHER

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

CHAN SHANNON MELISSA

Resident Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shannon M Chan, MBCHB, FRCS

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

The Chinese Universtiy of Hong Kong

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Shannon M Chan, MBCHB, FRCS

Role: CONTACT

shannonchan@surgery.cuhk.edu.hk

35052627

Anthony YB Teoh, MBCHB, FRCS

Role: CONTACT

anthonyteoh@surgery.cuhk.edu.hk

35052627

Facility Contacts

Shannon M Chan, MBCHB, FRCS

Role: primary

shannonchan@surgery.cuhk.edu.hk

35052627

Anthony YB Teoh, MBCHB, FRCS

Role: backup

anthonyteoh@surgery.cuhk.edu.hk

35052627

Other Identifiers

CRE2015.530

Identifier Type: -

Identifier Source: org_study_id