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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastric Cancer
- Sponsor
- Seoul National University Bundang Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Tolerance of diet for 24 hours
- Last Updated
- 4 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 total gastrectomy and proximal gastrectomy for gastric cancer, receiving either ERAS protocol or conventional postoperative cares.
Investigators
Sang-Hoon Ahn
Profesor
Seoul National University Bundang Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Tolerance of diet for 24 hours
Time Frame: 4 days after surgery
Tolerance of diet for 24 hours. Able to eat one third of more of soft-blend meal without abdominal discomfort, bloating, nausea, or vomiting
Analgesic-free
Time Frame: 4 days after surgery
Analgesic-free (oral or IV analgesic drugs not necessary after cessation of PCA)
Safe ambulation
Time Frame: 4 days after surgery
Safe ambulation (ambulation of 600m without assistance)
Afebrile status without major complications
Time Frame: 4 days after surgery
Afebrile status without major complications (fever defined as body temperature greater than 37.5)
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)
- Time to first bowel motion(up to 7 days after surgery)