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

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Abstract

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.

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Data used to support the findings of this study are available from the corresponding author upon reasonable request.

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Authors and Affiliations

  1. Research Institute of Clinical Surgery, Pirogov Russian National Research Medical University, Ostrovityanov str., 1, 117997, Moscow, Russia

    Taras Nechay, Svetlana Titkova, Alexander Tyagunov, Mikhail Anurov & Alexander Sazhin

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  1. Taras Nechay
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  2. Svetlana Titkova
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  3. Alexander Tyagunov
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  4. Mikhail Anurov
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  5. Alexander Sazhin
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Contributions

TN, ST, MA and AS conceived and planned the study design. AS was involved in planning and supervised the work. ST and MA performed the analysis. TN, AE and ST drafted the manuscript and designed the tables. AS, AT and TN supervised the project. All authors provided critical feedback and helped shape the research, analysis and manuscript. All authors discussed the results and commented on the manuscript. All authors read and approved the final manuscript.

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Correspondence to Taras Nechay.

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Conflict of interest

Taras Nechay, Svetlana Titkova, Alexander Tyagunov, Mikhail Anurov and Alexander Sazhin certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript.

Ethics approval

The study had been approved by the local Ethics Committee of Pirogov Russian National Research Medical University (Protocol No. 161-30-01-17).

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All subjects gave informed voluntary consent for participation in the study.

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Study has been approved by the institutional ethics committee and have been performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments.

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Nechay, T., Titkova, S., Tyagunov, A. et al. Modified enhanced recovery after surgery protocol in patients with acute cholecystitis: efficacy, safety and feasibility. Multicenter randomized control study. Updates Surg 73, 1407–1417 (2021). https://doi.org/10.1007/s13304-021-01031-5

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