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Evaluation of enhanced recovery after surgery program components implemented in laparoscopic appendectomy: prospective randomized clinical study.

ABSTRACT:

Background

Laparoscopic appendectomy (LA) is a widely used surgical procedure. Patients often suffer from considerable postoperative pain and indigestion, which prolongs their in-hospital stay. Almost 10% of patients develop postoperative complications. The enhanced recovery after surgery (ERAS) program has proven its efficacy in elective surgery and could hypothetically improve LA outcomes. Currently, there is no ERAS program for LA.

Methods

A modified ERAS (mERAS) protocol was studied in a prospective, randomized nonblinded clinical trial. The mERAS group consisted of 50 patients; the control group, of 54 patients. The mERAS protocol included a patient information brochure; minimizing drain use; local anesthesia; low-pressure pneumoperitoneum; early mobilization and oral diet. The primary outcome was postoperative length of stay (pLOS).

Results

Modified protocol reduced median pLOS to 1.25 days vs 2 days in the controls (p < 0.0001). Twenty-one (42%) mERAS patients and 4 (7.4%) controls were discharged within 24 h (p < 0.001) after surgery; 0 readmissions were reported. Postoperative pain intensity assessed on the visual analogue scale was significantly lower in the mERAS group [mERAS vs control 0 h, 2 h, 6 h, 12 h and 24 h after surgery: 2.33 ± 2.12 vs 4.19 ± 2.08 (p < 0.0001), 2.27 ± 1.91 vs 4.02 ± 1.89 (p < 0.0001), 2.28 ± 1.98 vs 3.70 ± 1.57 (p = 0.0001), 1.98 ± 1.72 vs 3.43 ± 1.54 (p < 0.0001) and 1.80 ± 1.74 vs 3.00 ± 1.27 (p = 0.032), respectively)]. The severity of shoulder and neck pain was lower but its incidence was similar. Peristalsis recovery was achieved earlier in the study group (median (min-max))-mERAS 7 (2-34) h vs control 11 (3-43) h; p = 0.009) but did not affect the time of the first flatus 23 (2-72) h vs 29 (6-70) h, respectively; p = 0.499).

Conclusions

The modified ERAS program for LA has advantages over the traditional approach.

Registration

This trial was registered at ClinicalTrials.gov as NCT03754777 (27/11/2018).

SUBMITTER: Nechay T

PROVIDER: S-EPMC7329822 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:To study the implementation of an enhanced recovery after surgery (ERAS) program at a large University Hospital from "pilot study" to "standard of care".The study was designed as a prospective single centre cohort study. A prospective evaluation of compliance to a protocol based on full application of all ERAS principles, through the progressive steps of its implementation, was performed. Results achieved in the initial pilot study conducted by a dedicated team (n = 47) were compared to those achieved in the shared protocol phase (n = 143) three years later. Outcomes were length of postoperative hospital stay, readmission rate, compliance to the protocol and morbidity. Primary endpoint was the description of the results and the identification of critical issues of large scale implementation of an ERAS program in colorectal surgery emerged in the experience of a single center. Secondary endpoint was the identification of interventions that have been proven to be effective for facilitating the transition from traditional care pathways to a multimodal management protocol according to ERAS principles in colorectal surgery at a single center.During the initial pilot study (March 2009 to December 2010; 47 patients) conducted by a dedicated multidisciplinary team, compliance to the items of ERAS protocol was 93%, with a median length of hospital stay (LOS) of 3 d. Early anastomotic fistulas were observed in 2 cases (4.2%), which required reoperation (Clavien-Dindo grade IIIb). None of the patients had been discharged before the onset of the complication, which could therefore receive prompt treatment. There were also four (8.5%) minor complications (Clavien-Dindo grade II). Thirty days readmission rate was 4%. Perioperative mortality was nil. After implementation of the protocol throughout the Hospital in unselected patients (May 2012 to December 2012; 147 patients) compliance was 74%, with a median LOS of 6 d. Early anastomotic fistulas were observed in 11 cases (7.7%), 5 (3.5%) of which required reoperation (Clavien-Dindo grade IIIb). Two early anastomotic fistulas were treated by radiologic/endoscopic manoeuvres and 4 were treated conservatively. There were also 36 (25.2%) minor complications, 21 (14.7%) of which were Clavien-Dindo grade II and 15 (10.5%) of which were Clavien-Dindo grade?I. Only two patients whose course was adversely affected by the development of an anastomotic leak had been discharged before the onset of the complication itself, requiring readmission. Readmission rate within 30 d was 4%. Perioperative mortality was 1%.Our results confirm that introduction of an ERAS protocol for colorectal surgery allows quicker postoperative recovery and shortens the length of stay compared to historical series.