Enhanced Recovery After Surgery in Autologous Breast Reconstruction: A Pilot Randomized Controlled Trial

Abstract

Background: Enhanced recovery after surgery (ERAS) is an approach to perioperative care shown to shorten hospital length of stay (LoS) and decrease opioid use after colorectal surgery. There is increasing interest in applying ERAS to breast reconstruction, but the supporting evidence is limited. In this pilot study we evaluated the feasibility of conducting a randomized controlled trial (RCT) comparing ERAS to standard perioperative care among patients undergoing abdominal-based autologous breast reconstruction (AABR) for breast cancer. Methods: We conducted a parallel two-arm pilot RCT of adult patients undergoing AABR between November 2019 and April 2020. Patients were randomly assigned to ERAS or standard perioperative care. Feasibility outcomes included patient rates of eligibility, recruitment, retention, and adherence to study protocol. The primary clinical outcome was median hospital length of stay. Secondary clinical outcomes included in-hospital opioid use, adverse events at 30-days, and quality of life questionnaires including BREAST-Q and EQ-5D-5L at 30-days. Results: Of 22 screened patients, 21 (95.4%) were eligible for the study and 20 patients (95.2% of eligible) consented to study enrollment. Two patients did not undergo surgery due to COVID-19 related cancellations. Among the 18 randomized patients (90%) 10 received the study intervention and 8 received standard care. All patients undergoing surgery completed the trial with 30-day follow-up. There was 85.8% adherence to study protocol items in the ERAS group. The ERAS group had a slightly shorter median hospital length of stay (ERAS 4 days, IQR 3-5; Standard care 4.5 days, IQR 3.25-5.75) and lower mean total oral morphine equivalent consumed (ERAS 82.3mg, SD 66.5; Standard care 408.1mg, SD 368.6). Conclusions: This pilot study supports the feasibility of a larger RCT evaluating effectiveness of ERAS, as demonstrated by high rates of patient recruitment, study completion, and adherence to study protocols. Effectiveness outcomes also encourage a larger RCT.