Upper Vaginectomy Versus Brachytherapy in Patients With Early Stage Endometrial Cancer Treated With Laparoscopic Surgery: a Randomized Controlled Study.
Women with ESEC scheduled for laparoscopic surgery will be enrolled and randomized in three
arms [vaginectomy group (VG), brachytherapy group (BG), and control group (CG)]. All
laparoscopic procedures will consist of total hysterectomy, bilateral salpingo-oophorectomy,
peritoneal washing, systematic inspection of peritoneal cavity and biopsy of each suspect
lesion, and pelvic (and eventual para-aortic) lymphadenectomy. In VG an upper vaginecomy
will be added to standard laparoscopic procedures followed by observation, whereas BG will
receive post-operative brachytherapy. CG will be treated with standard protocol for
management of ESEC according to National Comprehensive Cancer Network (www.nccn.org).
Safety and efficacy data will be recorded in each group for 24 months of follow-up.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less
will be considered significant.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Vaginal cuff recurrences
Stefano Palomba, MD
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Italy: National Institute of Health