CompletedNot Applicable

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

Spain84 participantsStarted 2022-07-11

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 a…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time taken to perform surgery

Timeframe: Perioperative

Trial details

NCT IDNCT07074067

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-27

View on ClinicalTrials.gov More Endometrial Adenocarcinoma trials