Recruitment
Between December 2018 and October
2019, a total of 397 women referred to the Peking Union Medical College
Hospital were screened for eligibility. 243 women did not meet the
inclusion criteria, and 10 women declined to participate in the trial.
Of the 144 eligible women, 72 were randomly assigned to the intervention
group and 72 to the control group (Fig. 1). Baseline characteristics of
the two groups did not differ significantly (Table 1). Three patients
withdrew their informed consent and 5 patients did not undergo eligible
surgery. One patient with endometrial carcinoma allocated to control
group had laparoscopic surgical staging instead of laparoscopic
hysterectomy given the suspected myometrial invasion indicated by MR
imaging. In addition, one laparoscopic myomectomy in the controlled
group was converted to transabdominal hysterectomy due to intraoperative
hemorrhage. After randomization, 67 women in the
intervention group and 69 women in the control group completed their
surgical procedures and received corresponding perioperative management
(per-protocol analysis, Appendix S1).
Protocol compliance in both the groups is presented in Table 2. The
compliance regarding key elements of the full ERAS program was
significantly higher in the intervention group than in the control
group.