NCT01938313

Early Recovery After Surgery (ERAS) Versus Conventional Protocol After Laparoscopic Gastrectomy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
PROCEDURE	ERAS perioperative cares	1. Patient's preoperative counseling \& education before surgery 2. No Bowel preparation 3. Oral Carbohydrate Solution (OCS) loading until 2hours before surgery 4. Fluid restriction \& Management by pulse contour analysis or transesophageal doppler 5. Early mobilization 6. Early oral feeding (postoperative 1 day - sips of water, 2 days - semifluid diet (SFD), 3 days - soft blended diet (SBD)) 7. Epidural patient controlled analgesics (no opioids analgesics) 8. Postoperative Nausea Active Control 9. Thromboembolism prophylaxis by low molecular weighted heparin (LMWH) 10. Perioperative High content Oxygen therapy 11. No drain insertion 12. No Levin tube 13. Patients will be discharged at POD#4 if there's no problem.
PROCEDURE	Conventional perioperative cares	1. No Patient's preoperative counseling \& education before surgery 2. Bowel preparation 3. No Oral Carbohydrate Solution (OCS) loading until 2hours before surgery 4. Conventional Fluid Management by clinical signs (Urine output, heart rate etc.) 5. Conventional Mobilization 6. Conventional oral feeding (POD#2 SOW, #3 SFD, #4 SBD) 7. IV PCA 8. Postoperative Nausea Control if needed 9. No Thromboembolism prophylaxis 10. No or Low Content Oxygen therapy 11. Routine drain insertion 12. Levin tube insertion if needed

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-08-01
• Completion: 2016-04-01
• First posted: 2013-09-10
• Last updated: 2017-01-05

Locations

1 site across 1 country: South Korea