Early non-compliance to ERAS in gynecological open surgery for malignancies, and post-operative complications: a multicenter, prospective, observational, cohort study.
Ferrari F., Bizzarri N., Fagotti A., Scambia G., Gozzini E., Soleymani Majd H., Rota M., Odicino F.
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.