ERAS (Early Recovery After Surgery) Protocol After Laparoscopic Total Gastrectomy and Proximal Gastrectomy

Study Overview
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Brief Summary
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Enhanced Recovery After Surgery (ERAS) programs have been introduced with purposes of reducing the surgical stress response and obtaining optimal recovery after surgery.

Detailed Description
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There is strong evidence of the usefulness of the ERAS programs in patients undergoing colorectal surgery in terms of significantly reduced postoperative complications and shorter length of hospital stay, compared to the patients of conventional treatment. However, few studies exist about the implication of ERAS programs in the laparoscopic gastrectomy. The aim of this study was to compare the recovery rate, morbidity, and quality of life in the patients undergoing laparoscopic total gastrectomy and proximal gastrectomy for gastric cancer, receiving either ERAS protocol or conventional postoperative cares.

Official Title
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Comparison of ERAS (Early Recovery After Surgery) Protocol With Conventional Protocol After Laparoscopic Total Gastrectomy and Proximal Gastrectomy: A Prospective Randomized Controlled Trial (Phase II Study)

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: ERAS perioperative cares
* Procedure: Conventional perioperative cares


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective surgery American Society of Anesthesiologists (ASA) scores < 3 Gastric cancer, adenocarcinoma, possible to perform laparoscopic total gastrectomy and proximal gastrectomy Informed consent No other treatment (Radiation, Chemotherapy or Immunotherapy) on this gastric cancer or other type of cancer. No systemic inflammatory disease Exclusion Criteria: conversion to open

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ERAS perioperative cares<br>Patients planned to undergoing laparoscopic total gastrectomy, following the ERAS protocols | Procedure: ERAS perioperative cares<br>* Patient's preoperative counseling & education before surgery No Bowel preparation Oral Carbohydrate Solution (OCS) loading until 2hours before surgery Fluid restriction & Management by pulse contour analysis or transesophageal doppler Early mobilization Early oral feeding (postoperative 1 day - sips of water, 2 days - semifluid diet (SFD), 3 days - soft blended diet (SBD)) Epidural patient controlled analgesics (no opioids analgesics) Postoperative Nausea Active Control Thromboembolism prophylaxis by low molecular weighted heparin (LMWH) Perioperative High content Oxygen therapy No drain insertion No Levin tube Patients will be discharged at POD#4 if there's no problem.<br>|
| Active Comparator: Conventional perioperative cares<br>Patents will be managed by our hospital's critical pathways | Procedure: Conventional perioperative cares<br>* No Patient's preoperative counseling & education before surgery Bowel preparation No Oral Carbohydrate Solution (OCS) loading until 2hours before surgery Conventional Fluid Management by clinical signs (Urine output, heart rate etc.) Conventional Mobilization Conventional oral feeding (POD#2 SOW, #3 SFD, #4 SBD) IV PCA Postoperative Nausea Control if needed No Thromboembolism prophylaxis No or Low Content Oxygen therapy Routine drain insertion Levin tube insertion if needed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance of diet for 24 hours | Tolerance of diet for 24 hours. Able to eat one third of more of soft-blend meal without abdominal discomfort, bloating, nausea, or vomiting | 4 days after surgery | 
| Analgesic-free | Analgesic-free (oral or IV analgesic drugs not necessary after cessation of PCA) | 4 days after surgery | 
| Safe ambulation | Safe ambulation (ambulation of 600m without assistance) | 4 days after surgery | 
| Afebrile status without major complications | Afebrile status without major complications (fever defined as body temperature greater than 37.5) | 4 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative length of hospital stay | Postoperative length of hospital stay | up to 4 weeks after surgery | 
| Time to tolerance of a full diet | Time to tolerance of a full diet | up to 1 month after surgery | 
| Time to first bowel motion | Time to first bowel motion | up to 7 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, ERAS (early recovery after surgery), laparoscopic total gastrectomy