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

Abstract

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, 2e3] vs 4 [interquartile range, 4e7] 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, 79.7e89.8), 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.

Level I evidence establishes enhanced recovery after surgery as standard of care in gynecologic surgery: now is the time to implement!

“…12,13 However, some have questioned the validity of ERAS in gynecology as these aforementioned studies are based on cohort-sequential (pre-vs post-) designs, and it has been argued that they are prone to observer bias and the Hawthorne effect. 14 In this issue of the Journal, the article "Validation of an enhanced recovery after surgery protocol in gynecological surgery: an Italian randomized study" 15 provides level I evidence to support the efficacy of ERAS in our specialty. Ferrari and colleagues 15 randomly assigned 168 women to either a standard perioperative care arm or an ERAS arm.…”

“…14 This study implemented few of the recommended ERAS elements in the guidelines and failed to report on compliance with many elements in their protocol. In contrast, the ERAS protocol described by Ferrari et al 15 is compliant with the RECOvER checklist 16 and aligned with ERAS gynecology guidelines. 5e7 Ferrari and colleagues 15 reported their compliance on nearly 40 items, with an overall average ERAS protocol compliance of 85%.…”

“…In contrast, the ERAS protocol described by Ferrari et al 15 is compliant with the RECOvER checklist 16 and aligned with ERAS gynecology guidelines. 5e7 Ferrari and colleagues 15 reported their compliance on nearly 40 items, with an overall average ERAS protocol compliance of 85%. 15 This is impressive and among the highest compliance achieved so far in the ERAS literature.…”

“…5e7 Ferrari and colleagues 15 reported their compliance on nearly 40 items, with an overall average ERAS protocol compliance of 85%. 15 This is impressive and among the highest compliance achieved so far in the ERAS literature. It is possible that this high compliance was a result of splitting the hospital surgeons and staff into 2 groups (ERAS and standard care) so that there would be no crossover (and confusion) about what care pathway to follow.…”

“…Volume status is currently a topic of much debate in the ERAS arena, particularly in relation to the recent Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery trial. 18 Although it appears that measures were taken by Ferrari and colleagues 15 to achieve euvolemia (avoidance of mechanical bowel preparation, carbohydrate loading, use of goal-directed fluid therapy), they did not quantify differences in fluids between the groups, which would have provided more objective information on this important outcome.…”