Early non-compliance to ERAS in gynecological open surgery for malignancies, and post-operative complications: a multicenter, prospective, observational, cohort study

Background: Open surgical procedures for gynecological malignancies have a potential risk of post-operative complications and hence prolonged hospitalization, despite adherence to an Enhanced Recovery After Surgery (ERAS) protocol.

Primary objective: To investigate the relationship between non-compliance to an ERAS protocol in the post-operative setting and the rate of post-operative complications, in women who underwent open surgery for gynecological malignancies.

Study hypothesis: Early non-compliance with the ERAS protocol increases the risk of post-operative complications.

Trial design: Multicenter, prospective, observational, cohort study.

Major inclusion criteria: Patients with histologically proven gynecological cancer (endometrial, uterine, tubo-ovarian, and cervical) undergoing elective open surgery and managed according to ERAS guidelines.

Exclusion criteria: Patients with post-operative recovery in an intensive care unit, undergoing anterior or total pelvic exenteration or intraperitoneal chemotherapy. Previous radiotherapy or previous non-gynecological major abdominal surgery.

Primary endpoint: Association of non-compliance with the ERAS protocol using five selected indicators on post-operative day 2 with the rate of 30-day post-operative complications.

Sample size: 600 patients will be enrolled in the study.

Estimated dates for completing accrual and presenting results: At present, 106 patients have been recruited. Based on this, the accrual should be completed in 2025. Results should be presented at the end of 2025.

Trial registration: NCT05738902.