Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2017
Adapted ERAS Pathway vs. Standard Care in Patients with Perforated Duodenal Ulcer-a Randomized Controlled Trial.
Сравнительное исследованиеEquivalence TrialСтатьяНазвание и аннотация: Перевод в очереди
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Mohsina Subair, Shanmugam Dasarathan, Sureshkumar Sathasivam, Kundra Pankaj, Mahalakshmy T, Kate Vikram
Аннотация
OBJECTIVES: The objective of this study was to evaluate the feasibility and efficacy of ERAS pathways in patients undergoing emergency simple closure of perforated duodenal ulcer (PDU).
METHODS: This single-center, prospective, open-labeled, superiority, RCT was carried out from August 2014 to July 2016. Patients of PDU undergoing open simple closure were randomized preoperatively in 1:1 ratio into standard care and adapted ERAS group. Patients with refractory shock, ASA class ≥3, and perforation size ≥1 cm were excluded. Primary outcome was the length of hospitalization (LOH). Secondary outcomes were functional recovery parameters and morbidity.
RESULTS: Forty-nine and 50 patients were included in standard care and ERAS group, respectively. Patients in ERAS group had a significantly early functional recovery (days) for the time to first flatus (1.47 ± 0.18; p < 0.001), first stool (2.25 ± 0.20; p < 0.001), first fluid diet (2.72 ± 0.38; p < 0.001), and solid diet (3.70 ± 0.44; p < 0.001). LOH in ERAS group was significantly shorter (mean difference of 4.41 ± 0.64 days; p < 0.001). There was a significant reduction in postoperative morbidity such as superficial SSI (RR 0.35, p = 0.02), postoperative nausea and vomiting (RR 0.28, p < 0.0001), and pulmonary complications (RR 0.24, p = 0.04) in the ERAS vs. standard care group with similar leak rates (1/50 vs.2/49).
CONCLUSION: ERAS pathways are safe and feasible in select patients undergoing emergency simple closure of PDU.
METHODS: This single-center, prospective, open-labeled, superiority, RCT was carried out from August 2014 to July 2016. Patients of PDU undergoing open simple closure were randomized preoperatively in 1:1 ratio into standard care and adapted ERAS group. Patients with refractory shock, ASA class ≥3, and perforation size ≥1 cm were excluded. Primary outcome was the length of hospitalization (LOH). Secondary outcomes were functional recovery parameters and morbidity.
RESULTS: Forty-nine and 50 patients were included in standard care and ERAS group, respectively. Patients in ERAS group had a significantly early functional recovery (days) for the time to first flatus (1.47 ± 0.18; p < 0.001), first stool (2.25 ± 0.20; p < 0.001), first fluid diet (2.72 ± 0.38; p < 0.001), and solid diet (3.70 ± 0.44; p < 0.001). LOH in ERAS group was significantly shorter (mean difference of 4.41 ± 0.64 days; p < 0.001). There was a significant reduction in postoperative morbidity such as superficial SSI (RR 0.35, p = 0.02), postoperative nausea and vomiting (RR 0.28, p < 0.0001), and pulmonary complications (RR 0.24, p = 0.04) in the ERAS vs. standard care group with similar leak rates (1/50 vs.2/49).
CONCLUSION: ERAS pathways are safe and feasible in select patients undergoing emergency simple closure of PDU.