So Hyun Kang1, Yoontaek Lee1, Sa-Hong Min1, Young Suk Park1, Sang-Hoon Ahn2,3, Do Joong Park1,4, Hyung-Ho Kim1,4. 1. Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Korea. 2. Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Korea. viscaria@snubh.org. 3. Department of Surgery, Seoul National University College of Medicine, Seoul, Korea. viscaria@snubh.org. 4. Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.
Abstract
BACKGROUND: The application of ERAS protocol has widely gained acceptance after gastrointestinal surgery. Well-designed, randomized, control trials are needed to evaluate fully its safety and efficacy in the field of gastric cancer. This study aims to compare the enhanced recovery after surgery (ERAS) protocol and the conventional perioperative care program after totally laparoscopic distal gastrectomy (TLDG) in gastric cancer. METHODS:Patients with gastric cancer indicated for TLDG were randomly assigned to either the ERAS group or the conventional group. The ERAS protocol included short fasting time, fluid restriction, early oral feeding, immediate mobilization, and use of epidural patient-controlled analgesia. Primary endpoint was recovery time, which was defined with the criteria of tolerable diet, safe ambulation, no requirement of additional analgesics, and afebrile state. Hospital stay, pain score, complications, and readmission rate were secondary endpoints. RESULTS: A total of 97 patients who underwent TLDG from October 2012 to August 2014 were enrolled (ERAS = 46, conventional = 51). The ERAS group had faster recovery time (111.6 ± 34.3 vs. 126.7 ± 30.7 h; p = 0.026) and significantly less pain through postoperative days 1-4. Possible hospital stay also was faster in the ERAS group (5.0 ± 1.9 vs. 5.7 ± 1.6 days, p = 0.038), but there was no difference in actual hospital stay. No difference was found in complication, and there was no mortality or readmission in both groups. CONCLUSIONS:ERAS is safe and enhances postoperative recovery after TLDG in gastric cancer. TRIAL REGISTRATION: The trial was registered in ClinicalTrials.gov (NCT01938313).
RCT Entities:
BACKGROUND: The application of ERAS protocol has widely gained acceptance after gastrointestinal surgery. Well-designed, randomized, control trials are needed to evaluate fully its safety and efficacy in the field of gastric cancer. This study aims to compare the enhanced recovery after surgery (ERAS) protocol and the conventional perioperative care program after totally laparoscopic distal gastrectomy (TLDG) in gastric cancer. METHODS:Patients with gastric cancer indicated for TLDG were randomly assigned to either the ERAS group or the conventional group. The ERAS protocol included short fasting time, fluid restriction, early oral feeding, immediate mobilization, and use of epidural patient-controlled analgesia. Primary endpoint was recovery time, which was defined with the criteria of tolerable diet, safe ambulation, no requirement of additional analgesics, and afebrile state. Hospital stay, pain score, complications, and readmission rate were secondary endpoints. RESULTS: A total of 97 patients who underwent TLDG from October 2012 to August 2014 were enrolled (ERAS = 46, conventional = 51). The ERAS group had faster recovery time (111.6 ± 34.3 vs. 126.7 ± 30.7 h; p = 0.026) and significantly less pain through postoperative days 1-4. Possible hospital stay also was faster in the ERAS group (5.0 ± 1.9 vs. 5.7 ± 1.6 days, p = 0.038), but there was no difference in actual hospital stay. No difference was found in complication, and there was no mortality or readmission in both groups. CONCLUSIONS: ERAS is safe and enhances postoperative recovery after TLDG in gastric cancer. TRIAL REGISTRATION: The trial was registered in ClinicalTrials.gov (NCT01938313).
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