Effectiveness of ERAS on Postoperative Recovery After Minimally Invasive Gastrectomy

Официальное название

Effectiveness of Enhanced Recovery After Surgery (ERAS) on Postoperative Recovery After Minimally Invasive Gastrectomy: A Multi-center Open-labeled Randomized Controlled Study

Обзор

This prospective, randomized, open-label, multicenter study is designed to evaluate the impact of an enhanced recovery after surgery (ERAS) protocol on the rate of meeting discharge criteria in patients undergoing minimally-invasive gastrectomy for gastric cancer. We hypothesize that implementation of our ERAS protocol will significantly increase the proportion of patients who meet standardized discharge criteria following minimally-invasive gastrectomy.

Подробное описание

Adult patients undergoing elective minimally invasive gastrectomy were randomly allocated to receive either the ERAS protocol (n = 154) or the conventional protocol (n = 154). The conventional group received the current standard perioperative care at our institution, whereas the ERAS group received a newly developed ERAS protocol, which included preoperative carbohydrate loading, reduced perioperative fasting duration, and multimodal opioid-sparing analgesia. The primary outcome was the proportion of patients who met standardized discharge criteria at 9:00 AM on postoperative day 4. Secondary outcomes included the EQ-5D-5L index assessed at 24, 48, 72, and 96 hours postoperatively; pain intensity at rest and during coughing measured using an 11-point numeric rating scale at 2, 24, 48, and 72 hours postoperatively; gastrointestinal dysfunction assessed using the I-FEED score at 24, 48, and 72 hours postoperatively; the incidence of postoperative nausea and vomiting within 0-24, 24-48, and 48-72 hours after surgery; the incidence of major postoperative complications classified by the Clavien-Dindo grading system during hospitalization; and postoperative length of hospital stay.

Вмешательства

• Процедура ERAS protocol
  The ERAS protocol includes pre-admission patient education through audiovisual materials; reduction of perioperative fasting duration with preoperative carbohydrate loading and early postoperative oral intake; multimodal prophylaxis for postoperative nausea and vomiting; early removal of surgical drains and intravenous lines; early mobilization; and multimodal analgesia aimed at minimizing postoperative opioid use. The detailed protocol used in this study has been published previously \[https://

Первичные конечные точки

• Proportion of patients who fulfilled all of the predefined discharge criteria [Срок оценки: At 9:00 AM on postoperative day]

Вторичные конечные точки (5)

• Postoperative pain score [Срок оценки: postoperative 2, 24, 48, and 72 hours]
• Postoperative gastrointestinal dysfunction [Срок оценки: postoperative 24, 48, and 72 hours]
• Postoperative nausea and vomiting [Срок оценки: From the end of surgery to 24, 48, and 72 hours postoperatively]
• Quality of recovery assessed using the EQ-5D-5L questionnaire [Срок оценки: postoperative 24, 48, and 72 hours]
• Major postoperative complication [Срок оценки: At 30 days postoperatively]

Критерии участия

Критерии включения

• Adults aged ≥19 years scheduled to undergo elective laparoscopic or robotic gastrectomy for gastric cancer
• American Society of Anesthesiologists physical status classification I to III
• Ability to provide written informed consent, demonstrate understanding of the study protocol, and complete patient-reported outcome measures appropriately

Критерии исключения

• Requirement for resection of organs other than the stomach during surgery (except for cholecystectomy)
• History of upper abdominal surgery (except for cholecystectomy)
• Known hypersensitivity to fentanyl, ropivacaine, acetaminophen, or non-steroidal anti-inflammatory drugs
• Determined by the investigator or study personnel to be otherwise unsuitable for participation in the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 10 центров

• Pusan National University Hospital — Busan
• Dongsan Hospital, Keimyung University School of Medicine — Daegu
• Chungnam National University Hospital — Daejeon
• National Cancer Center — Goyang
• Seoul National University Bundang Hospital — Seongnam
• Seoul National University Hospital — Seoul
• Seoul St. Mary's Hospital — Seoul
• Severance hospital — Seoul
• … и ещё 2 центра

Публикации

• Lee HJ, Kim J, Koo BW, Suh YS, Lee JM, Han DS, Hong SH, Lee HH, Yoo YC, Kim HI, Rho JY, Yoon HM, Kim HY, Hur H, Kim HJ, Choi CI, Hong B, Lee SI, Park K, Ryu SW, Park DJ. Survey of Perioperative Practices in Gastric Cancer Surgery for Establishing an Enhanced Recovery After Surgery Program Across 10 Tertiary Hospitals in South Korea. J Gastric Cancer. 2025 Jul;25(3):424-436. doi: 10.5230/jgc.2025.2 PMID 40631472
• Lee HJ, Kim J, Yoon SH, Kong SH, Kim WH, Park DJ, Lee HJ, Yang HK. Effectiveness of ERAS program on postoperative recovery after gastric cancer surgery: a randomized clinical trial. Int J Surg. 2025 May 1;111(5):3306-3313. doi: 10.1097/JS9.0000000000002328. PMID 40072360

Идентификаторы

NCT: NCT06984952 · 2501-115-1609

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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