Effectiveness of Enhanced Recovery After Surgery (ERAS) on Postoperative Recovery After Laparoscopic Distal Gastrectomy: An Open-labeled Randomized Controlled Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Enhanced Recovery After Surgery
- Sponsor
- Seoul National University Hospital
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Change of the Quality of recovery-15 during the first 72 hours after surgery
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This prospective, randomized, open-labeled study is designed to evaluate the impact of enhanced recovery after surgery (ERAS) protocol on postoperative quality of recovery in patients undergoing laparoscopic distal gastrectomy. We hypothesize that our ERAS protocol can significantly improve the postoperative quality of recovery in patients with laparoscopic distal gastrectomy.
Detailed Description
Adult patients undergoing elective laparoscopic distal gastrectomy are randomly allocated to receive the ERAS protocol (n=49) or conventional protocol (n=49). The conventional groups receive our current perioperative management. The ERAS groups receive our new ERAS protocol including preoperative carbohydrate loading, shortening of perioperative fasting time, and multimodal opioid-sparing analgesia. The primary outcome measure was the postoperative quality of recovery evaluated using the Korean version of Quality of recovery-15 at 24, 48, and 72 hours postoperatively. The secondary outcome measures were pain intensity at rest and during coughing evaluated using an 11-point numeric rating scale at 24, 48, and 72 hours postoperatively, gastrointestinal dysfunction evaluated using the I-FEED score at 24, 48, and 72 hours postoperatively, the occurrence of postoperative nausea and vomiting during the first postoperative 24 hours, postoperative 24 to 48 hour period, and postoperative 48 to 72 hour period, the occurrence of major postoperative complications according to the Clavien-Dindo classification during hospitalization, and length of hospital stay.
Investigators
Hojin Lee, MD, PhD
Professor
Seoul National University Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients scheduled to undergo elective laparoscopic distal gastrectomy
- •American Society of Anesthesiologists (ASA)physical classification I-II
- •ECOG Performance Status Scale 0 or 1
- •Willingness and ability to sign an informed consent document
Exclusion Criteria
- •Patients with chronic pain
- •Gastrectomy with combined resection of other organs
- •Patients with history of upper abdominal surgery
- •Allergies to anesthetic or analgesic medications (fentanyl, ropivacaine, acetaminophen, NSAIDs)
- •Medical or psychological disease that can affect the treatment response
Outcomes
Primary Outcomes
Change of the Quality of recovery-15 during the first 72 hours after surgery
Time Frame: postoperative 24, 48, and 72 hours
Korean version of Quality of recovery-15 questionnaire (0-150): 0, "very poor recovery"; 150, "excellent recovery"
Secondary Outcomes
- Postoperative pain score(postoperative 24, 48, and 72 hours)
- Total fentanyl consumption(From the end of surgery to 24, 48, and 72 hours postoperatively)
- Postoperative nausea and vomiting(From the end of surgery to 24, 48, and 72 hours postoperatively)
- Postoperative gastrointestinal dysfunction(postoperative 24, 48, and 72 hours)
- Recovery time(Evaluate every hour starting from 9A on the postoperative day 3 up to discharge)