NCT07074067

V-Notes Hysterectomy in Patients With Endometrial cáncer Compared With Laparoscopic Surgery (Robotically Assisted or Not): ENOLA TRIAL

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The v-NOTES surgical approach may provide important advantages over the already established effective technique (laparoscopy) for safely and successfully removing the uterus and adnexa in patients with low-grade endometrioid adenocarcinoma FIGO IA and atypical endometrial hyperplasia, such as a better aesthetic outcome, a shorter hospital stays, and a decrease in pain and postoperative complications. without increasing surgical time and with equal safety for the patient.

Detailed description

A prospective, open-label, longitudinal, randomized, longitudinal, blind-blind third-party (observer-blind) clinical trial will be conducted. Patients with a diagnosis of endometrioid adenocarcinoma IA G1-G2 and atypical endometrial hyperplasia will be recruited in the Gynecology Oncology consultations of the HCUVA. Patients who meet all the inclusion criteria and none of the exclusion criteria from the trial will be informed about the study, and if they agree to participate, they will sign the informed consent. The data will be included in the Hospital's computer system (Selene), and will be compiled in a database that will be accessible only by the physicians included in the study. Subsequently, this database will be analysed by a statistician from outside the HCUVA's Gynaecology Service. After surgery, patients will be monitored after surgery, first on the hospitalization floor prior to discharge, and later in face-to-face consultations as well as by telephone.

Conditions

• Endometrial Adenocarcinoma

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic surgery	the laparoscopic (LPC) arm, 21 patients will be assigned to conventional LPC and another 21 to robotic surgery, consecutively.
PROCEDURE	surgery via v-NOTES	surgery via v-NOTES

Timeline

• Start date: 2022-07-11
• Primary completion: 2025-05-27
• Completion: 2025-05-27
• First posted: 2025-07-20
• Last updated: 2025-07-20

Locations

1 site across 1 country: Spain