Modified enhanced recovery after surgery protocol in patients with acute cholecystitis: efficacy, safety and feasibility. Multicenter randomized control study.

Laparoscopic cholecystectomy (LC) is a common surgical procedure in acute cholecystitis (AC). Patients often suffer from considerable postoperative pain and indigestion, which prolongs in-hospital stay. The enhanced recovery after surgery (ERAS) program has proven its efficacy in elective surgery and could hypothetically improve outcomes of emergency LC. Currently, there is no ERAS program for LC in patients with AC. A modified ERAS (mERAS) protocol was studied in a prospective, randomized non-blinded clinical trial (NCT03754751). The mERAS group consisted of 88 patients the control group of 101 patients. The modified protocol included a patient information brochure; minimizing drain use; local anesthesia; low-pressure pneumoperitoneum; PONV prophylaxis, early mobilization and oral diet. The primary outcome was postoperative length of stay (pLOS). The postoperative length of stay in the mERAS group was shorter (24 (21-45.5) h) than in the control (45 (41-68) h) (p < 0.0001). One re-admission in the mERAS group was reported (p = 0.466). There difference in complications was insignificant (mERAS 6.8% vs 5% p = 0.757). Post-operative pain intensity was significantly lower in the mERAS group immediately after awaking (3.7 ± 1.8 vs 5.4 ± 1.3 p < 0.0001), 2 h (3.3 ± 1.7 vs 4.9 ± 1.6 p =  0.0006), 6 h (2.9 ± 1.5 vs 4.2 ± 1.2 p  < 0.0001), 12 h (2.7 ± 0.9 vs 4.1 ± 1.2 p = 0.0001) and 24 h after surgery (2.1 ± 1.2 vs 3 ± 1.2 p <  0.0001). The incidence of shoulder and neck pain was lower in mERAS group (13.6% vs 34.7% p = 0.0009). Peristalsis recovery was similar in both groups. The proposed protocol improved postoperative recovery and reduced hospital stay in patients with AC without increasing the rate of complications or re-admissions.

RCT Entities:   Population Interventions Outcomes