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

NCT07074067 | Completed

• 1 other identifier: 2022-4-5-HCUVA
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Time taken to perform surgery

  Surgical time will be defined, in the case of the laparoscopic/robotic route, as the time elapsed from the insertion of the first trocar to the removal of the last one, and in the case of the v-NOTES route, as the time elapsed from the beginning of the vaginal surgery to the end of the surgery. The previous time of positioning of the patient, anesthesia, asepsis and sizing of the surgical field will not be taken into account

  Perioperative

Secondary Outcomes (6)

• AGE

  Day 1

• Body Mass Index

  Day 1

• times spent in surgical techniques

  1 day post surgery

• Measurement of post-surgical pain

  6 and 24 hours after the intervention

• Study of overall patient satisfaction upon hospital discharge

  Trough study completion, an average of a1 year

Study Arms (2)

Laparoscopic surgery

ACTIVE COMPARATOR

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

Procedure: Laparoscopic surgery

surgery via v-NOTES

EXPERIMENTAL

surgery via v-NOTES

Procedure: surgery via v-NOTES

Interventions

Laparoscopic surgery PROCEDURE

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

Laparoscopic surgery

surgery via v-NOTES PROCEDURE

surgery via v-NOTES

surgery via v-NOTES

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women with endometrial cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia: lead

Study Sites (1)

HCUVA

Murcia, Murcia, 30120, Spain

Location

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Rafael Guijarro Campillo, MD

  HCUVA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, open-label, longitudinal, randomized, longitudinal, blind-blind third-party (observer-blind)

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 20, 2025
• Study Start: July 11, 2022
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

ES (1)