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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERAS group | Experimental | Perioperative care for laparoscopic distal gastrectomy is managed according to ERAS protocol. |
|
| Conventional group | No Intervention | Perioperative care for laparoscopic distal gastrectomy is managed according to our current perioperative practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERAS protocol | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the Quality of recovery-15 during the first 72 hours after surgery | Korean version of Quality of recovery-15 questionnaire (0-150): 0, "very poor recovery"; 150, "excellent recovery" | postoperative 24, 48, and 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain score | 11-pointed NRS pain score at resting/coughing NRS (0-10): 0,"no pain"; 10, "worst pain imaginable" | postoperative 24, 48, and 72 hours |
| Total fentanyl consumption | postoperative fentanyl consumption (mcg) via IV patient controlled analgesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Do Joong Park, MD, PhD | Seoul National University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | KS013 | South Korea |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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A prospective randomized open-labeled study
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| From the end of surgery to 24, 48, and 72 hours postoperatively |
| Postoperative nausea and vomiting | Incidence of postoperative nausea and vomiting (%) | From the end of surgery to 24, 48, and 72 hours postoperatively |
| Postoperative gastrointestinal dysfunction | I-FEED score 3 points or more (postoperative gastrointestinal intolerance and dysfunction) | postoperative 24, 48, and 72 hours |
| Recovery time | 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 | Evaluate every hour starting from 9A on the postoperative day 3 up to discharge |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |