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Randomized clinical trial of enhanced recovery versus standard care after laparoscopic sleeve gastrectomy |
Lemanu DP, Singh PP, Berridge K, Burr M, Birch C, Babor R, MacCormick AD, Arroll B, Hill AG |
The British Journal of Surgery 2013 Mar;100(4):482-489 |
clinical trial |
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
BACKGROUND: Optimized perioperative care within an enhanced recovery after surgery (ERAS) protocol is designed to reduce morbidity after surgery, resulting in a shorter hospital stay. The present study evaluated this approach in the context of sleeve gastrectomy for patients with morbid obesity. METHODS: Patients were allocated to perioperative care according to a bariatric ERAS protocol or a control group that received standard care. These groups were also compared with a historical group of patients who underwent laparoscopic sleeve gastrectomy at the same institution between 2006 and 2010, selected using matched propensity scores. The primary outcome was median length of hospital stay. Secondary outcomes included readmission rates, postoperative morbidity, postoperative fatigue and mean cost per patient. RESULTS: Of 116 patients included in the analysis, 78 were allocated to the ERAS (40) or control (38) group and there were 38 in the historical group. There were no differences in baseline characteristics between groups. Median hospital stay was significantly shorter in the ERAS group (1 day) than in the control (2 days; p < 0.001) and historical (3 days; p < 0.001) groups. It was also shorter in the control group than in the historical group (p = 0.010). There was no difference in readmission rates, postoperative complications or postoperative fatigue. The mean cost per patient was significantly higher in the historical group than in the ERAS (p = 0.010) and control (p = 0.018) groups. CONCLUSION: The ERAS protocol in the setting of bariatric surgery shortened hospital stay and was cost-effective. There was no increase in perioperative morbidity. REGISTRATION NUMBER: NCT01303809 ClinicalTrials.gov.
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