Comparison of ERAS (Early Recovery After Surgery) Protocol With Conventional Protocol After Laparoscopic Gastrectomy: A Prospective Randomized Controlled Trial (Phase II Study))
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Gastric Cancer
- Sponsor
- Seoul National University Bundang Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Recovering Rate
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Hyung-Ho Kim
Professor
Seoul National University Bundang Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Recovering Rate
Time Frame: 4 days after surgery
1. 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 2. Analgesic-free (oral or IV analgesic drugs not necessary after cessation of PCA) 3. Safe ambulation (ambulation of 600m without assistance) 4. 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.
Secondary Outcomes
- Postoperative length of hospital stay(up to 4 weeks after surgery)
- Time to tolerance of a full diet(up to 1 month after surgery)
- Complications during the admissionTime to first bowel motion(up to 30 days after surgery)
- Quality of life(up to 1 month after surgery)
- Readmission rate(up to 30 days after surgery)
- Time to first bowel motion Time to first bowel motion(up to 7 days after surgery)
- Pain scores based on a visual analog scale the day of surgery and the subsequent 3 days(up to 3 days after surgery)