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

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OBJECTIVE The study aims to validate an enhanced recovery after surgery (ERAS) protocol in gynecological surgery both for benign and malignant disease (endometrial cancer and advanced ovarian cancer) and to… Click to show full abstract

OBJECTIVE The study aims to validate an enhanced recovery after surgery (ERAS) protocol in gynecological surgery both for benign and malignant disease (endometrial cancer and advanced ovarian cancer) and to measure the adherence to ERAS items in a randomized trial setting. STUDY DESIGN In this trial (NCT03347409), we randomly assigned patients to undergo standard perioperative care or ERAS protocol. The primary outcome is a shorter length of stay in favor of ERAS. Secondary outcomes include measurement of adherence to ERAS items, comparison of postoperative pain, vomiting and nausea, anesthesiological and surgical complications up to thirty days after surgery, rate of readmissions, the time-to-event in hours for bowel movements, flatus, drink, hunger, eating and walking and lastly 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 gynecological disease. RESULTS A total of 168 women were available for analysis, of them 85 (50.6%) underwent standard perioperative care while 83 (49.4%) were assigned to ERAS. The two groups were similar for age, BMI, comorbidities, anesthesiological risk, smoking habits, surgical access and complexity of surgical procedures. Seventy-two patients (42.9%) underwent surgery for benign surgery, 48 (28.6%) for endometrial cancer and 48 (28.6%) for ovarian cancer. Women in the ERAS group had a shorter length of stay [median 2 (IQR 2-3) versus 4 (IQR 4-7) days; p < .001]. A decreased rate of postoperative complications was noted for ERAS, as well as an earlier time to occur for all the events. Mean adherence to protocol items is 84.8% (CI 95% 79.7-89.8) and we registered a better satisfaction in the ERAS group. The shortening of the length of stay was confirmed also in the prespecified subgroup analysis. CONCLUSION Application of ERAS protocol in gynecological surgery translated in a shorter length of stay, regardless of surgical access and type of gynecological disease. Adherence to ERAS items in the setting of a randomized trial is high.

Keywords: surgery; gynecological surgery; study; protocol; length stay; protocol gynecological

Journal Title: American journal of obstetrics and gynecology
Year Published: 2020

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