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

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

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03160924
• Other study ID #: CRE2015.530
• Status: Recruiting
• Phase: Phase 3
• Start date: December 1, 2016
• Est. completion date: May 31, 2021

Study information

• Verified date: May 2020
• Source: Chinese University of Hong Kong
• Contact: Shannon M Chan, MBCHB, FRCS
• Phone: 35052627
• Email: shannonchan[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Enhanced Recovery After Surgery for Laparoscopic Gastrectomy for Patients With Gastric Cancer
• Stomach Neoplasms

Intervention

Other:
• Enhanced Recovery After Surgery (ERAS)
same as above as described in the "arms".

Locations

Country	Name	City	State
Hong Kong	The Chinese Universtiy of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative hospital stay	The number of days patient stays in hospital after the surgery	Within 30 days
Secondary	Serum lymphocyte counts	This is used to assess the patient's immunological status after the surgery.	Within 5 days of the surgery
Secondary	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.	Within 2 weeks
Secondary	Forced vital capacity	This will be done in terms of peak flow rate at bedside.	Within 2 weeks
Secondary	Mortality and morbidity	The morbidities would be recorded according to predefined criterion. Mortalities within 30 days would be included.	Within 30 days
Secondary	Readmission rate	Readmission of more than 24 hours would be counted as readmission	Within 30 days
Secondary	Quality of life assessments	This will be measured by European organisation for Research and Treatment of Cancer (EORTC)-stomach questionnaires	within 4 weeks
Secondary	Direct hospital costs	All costs involving the admission and readmissions	within 30days