Our analysis demonstrates that unselective implementation of ERAS protocol can be safe in a low volume unit and realize its advantage by a marked decrease in operation time, shortened LOS and with more patients securely discharge on POD1 without an increase in complications.
Since the concept of a multimodal approach to control postoperative pathophysiology and improve recovery was first introduced in 1997 [19], relevant protocols have evolved. The rationale is to hasten convalescence by reducing perioperative stress. From then onwards, guidelines have been established regarding recommendations for integral ERAS components in bariatric field [17]. Recently, several systemic reviews and meta-analyses have demonstrated the superiority of enhanced recovery protocols in terms of carrying out more efficient surgical procedures, lessening the length of hospitalization and effectively reducing overall morbidities compared with standard care [8, 20, 21]. That being said, to generally implement the ERAS regimen remains questionable since this approach is not without risks [9, 22]. For instance, Rebibo et al. reported a cohort with a 40% increase in the readmission rate (from 4% to 5.6%) [23] and others observed an increase in the ER visit rate [24]. Using the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program data set, Inaba et al. found a significantly higher morbidity (3.76% vs. 1.54%) and mortality rate (0.94% vs. 0.05%) when comparing same-day discharge to POD1 discharge [25]. Similarly, Morton et al. discovered that an LOS of ≤1 day was associated with a significantly increased risk of 30-day mortality (OR 2.02) for RYGB patients [26]. In fact, ERAS be implemented under the setting of specialized high-volume centers is frequently deemed a prerequisite to conduct these projects safely [9]. For example, McCarty et al. proposed that 84% of patients can be discharged within 23 hours postoperatively with a readmission rate as low as 1.7% for 2000 consecutive RYGB patients [27]. Similarly, Jacobsen et al. published an ERAS cohort based on a single high-volume center with a significantly shortened hospital stay (from 3 days to 2 days), an early complication rate as low as 2.8% and a readmission rate of only 1.9% [28]. In this regard, it seems reckless to conduct ERAS in a non-accredited low volume unit with fewer than 50 perennial cases.
Moreover, unlike our study background, a vast accumulating experience can usually be found when referring to preceding research that has been conducted with low case numbers. Hahl et al. analyzed data from 318 patients who underwent RYGB during a 4-year period with excellent results showing a mean LOS of only 1.3 days and 83% of patients discharged on POD1 [29]. Notably, their accumulative experience at that time was already far more than five hundred cases. Similar to our study, Awad et al. introduce a series of 226 cases that comprised various bariatric procedures. With a low 30-day complication rate of only 4.4% and a readmission rate of 2.7% [12]; however, this particular study were conducted at a regional high-volume tertiary referral center. Therefore, whether these superior outcomes merely reflect clinician proficiency remains unclear. Some other studies were notably undertaken via independent patient-selection or procedure-selection process. Such as Sasse et al. presented a 38 RYGB case series with a 100% POD1 discharge rate and a low 30-day complication rate of only 2.6% [30]. However, their study group represented fewer than 3% of their total RYGB cases as a result of stringent patient selection. Likewise, Fares et al. accomplished a high POD1 discharge rate of up to 94.8% from a consecutive 96 RYGB case series in a small, teaching community hospital with only 5.2% complications [31]. Nevertheless, the study group comprised 55% of patients selected from a total caseload of 173. Lam et al. reported their recent work which yielding remarkable results in terms of 83.1% of patients achieving POD1 discharge with a 1.5% readmission rate whereas they selected 130 out of 240 total cases in their research, and all subjects were receiving SG [32]. Even so, there was no coherent criterion for subject selection and risk stratification among these studies. On the other hand, a noticeable tendency toward an increase in adverse outcomes was found in several studies that were specifically endorsed with an unselective approach. For example, Geubbels et al. followed a cohort of 360 unselected RYGB patients and found an increasing early complication rate (from 17.3% to 18.3%) and an increasing readmission rate (from 4.8% to 8.1%) after ERAS conduction [33]. Similarly, Mannaerts et al. reported a significantly higher minor complication rate (20.7% vs. 16.1%) and a higher ER visit rate (16.8% vs. 12.5%) [34]. By unselective approach, our series comprised various susceptible groups; for example, 5 (5.6%) patients were aged >65 yrs. (range, 65-74 yrs.), 4 (4.4%) patients had a BMI of >50 kg/m2 (range, 52.5-73.7 kg/m2), and two other patients had a wheelchair-bound status. Unlike the aforementioned studies, a tendency of decreasing 30-day ER visits (2 (2.2%) vs. 5 (8%)), readmissions (1 (1.1%) vs. 3 (4.8%)), 30-day complication rates (5 (5.5%) vs. 6 (9.7%)) was found via our ERAS regimen despite none of these values reaching statistical significance. Compared to an LOS ranging from 1 day to 2.9 days, readmission rates between 1.7% and 8.1%, early complication rates between 2.8% and 18.3%, and mortality rates of up to 0.7% across former, high-volume studies [12, 27-29, 35], a total LOS of 2.6 days was accomplished in our series and fall in line with these valuable large studies.
Further analysis and comparing patients discharged on POD1 with those discharged later, there was no statistically significant increase in ER visits (1/41 (2.4%) vs. 1/49 (2%)), readmissions (1 /41 (2.4%) vs. 0) or overall complication rates (1/41 (2.4%) vs. 4/49 (8.2%)). Therefore, our initial result did not come at the expense of patient safety.
It is clear that a major difference in procedures was noted between groups, with significantly more patients who underwent RYGB in the ERAS group. Subgroups analysis revealed similar trend of advantages after ERAS implementation in terms of operation time (RYGB, 128 min vs. 104 min; OAGB, 150 min vs.99 min), LOS (RYGB, 3.4 days vs. 2.5 days; OAGB, 3.3 days vs. 2.8 days) and accomplishment of POD1 discharge (RYGB, 0% vs. 54.7%; OAGB, 1.9% vs. 33.3%) with no increment of complications. Though there were lacks of comparison study regarding impact of ERAS for individual procedure, the index protocol benefits both procedures in current study. Another interesting finding in our study was OAGB (n=53) took significant longer op time than RYGB (n=8) in control group. In addition to the research sample is too small, our results can be partially explained by differences in the demographic characteristics between groups with RYGB comprising younger patients (31.3 yrs. vs. 39.8 yrs.) with a lower BMI (37.5 kg/m2 vs. 42.0 kg/m2) for these are well -identified factors that affect the operation time.
Our study shows that ERAS can be safely performed unselectively under low-volume setting and provided with beneficial effects usually reported from high-volume, specialized centers.