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

NCT ID: NCT07074067

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-11
• Study Completion Date: 2025-05-27

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic surgery

within the laparoscopic (LPC) arm, 21 patients will be assigned to conventional LPC and another 21 to robotic surgery, consecutively.

Group Type: ACTIVE_COMPARATOR

Laparoscopic surgery

Intervention Type: PROCEDURE

the laparoscopic (LPC) arm, 21 patients will be assigned to conventional LPC and another 21 to robotic surgery, consecutively.

surgery via v-NOTES

surgery via v-NOTES

Group Type: EXPERIMENTAL

surgery via v-NOTES

Intervention Type: PROCEDURE

surgery via v-NOTES

Interventions

Laparoscopic surgery

the laparoscopic (LPC) arm, 21 patients will be assigned to conventional LPC and another 21 to robotic surgery, consecutively.

Intervention Type: PROCEDURE

surgery via v-NOTES

surgery via v-NOTES

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age of majority (> 18 years)
• Willingness to participate in the study and signing of informed consent
• Histological diagnosis, by endometrial biopsy (either using a Cornier cannula or directed by diagnostic hysteroscopy) of atypical endometrial hyperplasia or low-grade endometrioid adenocarcinoma (G1-G2), with an initial stage (IA) at preoperative evaluation

Exclusion Criteria

Pregnant Women

• Nullicottitis
• Severe uterine prolapse (grade IV)
• Large myomatous uterus (greater than 18 weeks of gestation)
• Severe comorbidities that contraindicate surgery, such as sepsis, severe renal failure, severe cardiopulmonary disease, or severe coagulopathies 33
• Presence of previous illnesses or treatments that may have caused severe pelvic adhesions that obliterate the Douglas pouch and prevent vaginal entry, such as deep pelvic endometriosis, severe pelvic inflammatory disease, inflammatory bowel disease (ulcerative colitis, diverticulitis, Crohn's disease), or a history of pelvic radiotherapy, among others
• Concomitant presence of adnexal masses or formations of considerable size that are expected to substantially lengthen the uterus Surgical time due to the difficulty of extraction
• Contraindication to general anesthesia
• Active pelvic or lower urinary tract infection
• Clinical suspicion of advanced stage of the neoplasia
• Any histological type of endometrial cancer other than those described previously.
• High histological grade (G3)
• Current abnormality in cervical cytology (CVC) requiring more aggressive surgical intervention
• Revocation of informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rafael Guijarro Campillo, MD

Role: PRINCIPAL_INVESTIGATOR

HCUVA

Locations

HCUVA

Murcia, Murcia, Spain

Countries

Spain

Other Identifiers

2022-4-5-HCUVA

Identifier Type: -

Identifier Source: org_study_id