Early Recovery After Surgery (ERAS) Versus Conventional Protocol After Laparoscopic 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 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 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 20 < Age < 80 Gastric cancer, adenocarcinoma, possible to perform laparoscopic distal 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: Emergency operation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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 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 |
| --- | --- | --- |
| Recovering Rate | Tolerance of diet for 24 hours A. Able to eat one third of more of soft-blend meal without abdominal discomfort, bloating, nausea, or vomiting Analgesic-free (oral or IV analgesic drugs not necessary after cessation of PCA) Safe ambulation (ambulation of 600m without assistance) Afebrile status without major complications (fever defined as body temperature greater than 37.5) Above total 4 criteria should be satisfied for the evaluation of complete recovery. | 4 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative length of hospital stay |  | up to 4 weeks after surgery | 
| 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 | 
| Complications during the admissionTime to first bowel motion |  | up to 30 days after surgery | 
| Readmission rate |  | up to 30 days after surgery | 
| Pain scores based on a visual analog scale the day of surgery and the subsequent 3 days | postoperative 2hours, 6 hours, 1 days, 2 days, 3 days | up to 3 days after surgery | 
| Quality of life | European organization for research and treatment of cancer (EORTC) and gastrointestinal quality of life index (GIQLI) questionnaire on postoperative 5 days, 1 month | up to 1 month 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), fast track, laparoscopic gastrectomy