Adapted ERAS Pathway vs. Standard Care in Patients with Perforated Duodenal Ulcer-a Randomized Controlled Trial.

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.