Validation of an enhanced recovery after surgery protocol in gynecologic surgery: an Italian randomized study.

Tytuł:: Validation of an enhanced recovery after surgery protocol in gynecologic surgery: an Italian randomized study.
Autorzy:: Ferrari F; Department of Obstetrics and Gynecology, Spedali Civili, Brescia, Italy. Electronic address: .
Forte S; Department of Obstetrics and Gynecology, University of Brescia, Brescia, Italy.
Sbalzer N; Department of Anesthesia, Spedali Civili, Brescia, Italy.
Zizioli V; Department of Obstetrics and Gynecology, Spedali Civili, Brescia, Italy.
Mauri M; Department of Obstetrics and Gynecology, Spedali Civili, Brescia, Italy.
Maggi C; Department of Obstetrics and Gynecology, University of Brescia, Brescia, Italy.
Sartori E; Department of Obstetrics and Gynecology, University of Brescia, Brescia, Italy.
Odicino F; Department of Obstetrics and Gynecology, University of Brescia, Brescia, Italy.
Źródło:: American journal of obstetrics and gynecology [Am J Obstet Gynecol] 2020 Oct; Vol. 223 (4), pp. 543.e1-543.e14. Date of Electronic Publication: 2020 Jul 08.
Typ publikacji:: Journal Article; Randomized Controlled Trial; Validation Study
Język:: English
Imprint Name(s):: Publication: <2005->: New York : Elsevier
Original Publication: St. Louis.
MeSH Terms:: Enhanced Recovery After Surgery*
Recovery of Function*
Endometrial Neoplasms/*surgery
Gynecologic Surgical Procedures/*methods
Length of Stay/*statistics & numerical data
Ovarian Neoplasms/*surgery
Postoperative Complications/*epidemiology
Aged ; Female ; Genital Diseases, Female/surgery ; Guideline Adherence ; Humans ; Ileus/epidemiology ; Italy/epidemiology ; Lymph Node Excision ; Middle Aged ; Pain Measurement ; Pain, Postoperative/epidemiology ; Patient Readmission ; Patient Satisfaction ; Postoperative Nausea and Vomiting/epidemiology ; Time Factors
Contributed Indexing:: Keywords: enhanced recovery after surgery; gynecologic surgery; gynecology; ovarian cancer
Molecular Sequence:: ClinicalTrials.gov NCT03347409
Entry Date(s):: Date Created: 20200712 Date Completed: 20201123 Latest Revision: 20210306
Update Code:: 20240105
DOI:: 10.1016/j.ajog.2020.07.003
PMID:: 32652064
: Czasopismo naukowe

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Background: The enhanced recovery after surgery concept, which was introduced 20 years ago, is based on a multimodal approach to improve the functional rehabilitation of patients after surgery.
Objective: This study aimed to validate an enhanced recovery after surgery protocol in gynecologic surgery for both benign and malignant diseases (endometrial cancer and advanced ovarian cancer) and to measure the adherence to the enhanced recovery after surgery protocol items in a randomized trial setting.
Study Design: In this trial (NCT03347409), we randomly assigned patients to undergo standard perioperative care or enhanced recovery after surgery protocol. The primary outcome is a shorter length of stay in favor of the enhanced recovery after surgery protocol. Secondary outcomes include measurement of adherence to the enhanced recovery after surgery protocol items: comparison of postoperative pain, vomiting, and nausea; anesthesiologic and surgical complications up to 30 days after surgery; rate of readmissions; the time to event in hours for bowel movements, flatus, drinking, hunger, eating, and walking; and the quality of recovery using a validated questionnaire (QoR-15). Finally, we explored the length of stay in the prespecified subgroups at randomization, based on the type of surgical access and gynecologic disease.
Results: A total of 168 women were available for analysis: 85 women (50.6%) were assigned to the standard perioperative care group, and 83 women (49.4%) were assigned to the enhanced recovery after surgery protocol group. The 2 groups were similar for age, body mass index, comorbidities, anesthesiological risk, smoking habits, surgical access, and complexity of surgical procedures. Seventy-two patients (42.9%) underwent surgery for benign disease, 48 (28.6%) for endometrial cancer, and 48 (28.6%) for ovarian cancer. Women in the enhanced recovery after surgery protocol group had a shorter length of stay (median: 2 [interquartile range, 2-3] vs 4 [interquartile range, 4-7] days; P<.001). A decreased rate of postoperative complications was noted for the enhanced recovery after surgery protocol group, as well as an earlier time to occur for all the events. Mean adherence to protocol items was 84.8% (95% confidence interval, 79.7-89.8), and we registered a better satisfaction in the enhanced recovery after surgery protocol group. The shortening of the length of stay was confirmed also in the prespecified subgroup analysis.
Conclusion: Application of the enhanced recovery after surgery protocol in gynecologic surgery translated to a shorter length of stay regardless of surgical access and type of gynecologic disease. Adherence to the enhanced recovery after surgery protocol items in the setting of a randomized trial was high.
(Copyright © 2020 Elsevier Inc. All rights reserved.)

Comment in: Am J Obstet Gynecol. 2020 Oct;223(4):473-474. (PMID: 32977904)
Comment in: Am J Obstet Gynecol. 2021 Mar;224(3):336-337. (PMID: 33207233)
Comment in: Am J Obstet Gynecol. 2021 Mar;224(3):335-336. (PMID: 33207237)

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