Enhanced Recovery After Surgery
Conditions
Keywords
Enhanced Recovery After Surgery, Stomach Neoplasms, Gastrectomy, Pain, Postoperative
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.
Interventions
PROCEDUREERAS protocol
The ERAS protocol involves a pre-admission patient education using audiovisual videos, the reduction of perioperative fasting time with administration of preoperative carbohydrate loading and early resumption of oral feeding after surgery, multimodal postoperative nausea and vomiting prevention, early removal of the nasogastric tube and urinary catheter, and multimodal analgesia to minimize opioid consumption after surgery.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A prospective randomized open-labeled study
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of the Quality of recovery-15 during the first 72 hours after surgery | postoperative 24, 48, and 72 hours | Korean version of Quality of recovery-15 questionnaire (0-150): 0, very poor recovery; 150, excellent recovery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain score | postoperative 24, 48, and 72 hours | 11-pointed NRS pain score at resting/coughing NRS (0-10): 0,no pain; 10, worst pain imaginable |
| Total fentanyl consumption | From the end of surgery to 24, 48, and 72 hours postoperatively | postoperative fentanyl consumption (mcg) via IV patient controlled analgesia |
| Postoperative nausea and vomiting | From the end of surgery to 24, 48, and 72 hours postoperatively | Incidence of postoperative nausea and vomiting (%) |
| Postoperative gastrointestinal dysfunction | postoperative 24, 48, and 72 hours | I-FEED score 3 points or more (postoperative gastrointestinal intolerance and dysfunction) |
| Recovery time | Evaluate every hour starting from 9A on the postoperative day 3 up to discharge | Postoperative time satisfying the following four criteria: (1) tolerance of soft blended diet (SBD) for 24 h; (2) safe ambulation of 600 m without assistance; (3) Adequate pain control (NRS ≤ 3) with oral non opioid analgesics; and (4) No abnormal physical findings or laboratory test |
Countries
South Korea
Outcome results
None listed