Endometrial AdenocarcinomaENOLANCT07074067
V-Notes Hysterectomy in Patients With Endometrial cáncer Compared With Laparoscopic Surgery (Robotically Assisted or Not): ENOLA TRIAL
A study testing Laparoscopic surgery and surgery via v-NOTES in people with Endometrial Adenocarcinoma, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Adenocarcinoma
- What is being tested?
- Laparoscopic surgery and surgery via v-NOTES
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- 11 Jul 2022to 27 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Laparoscopic surgery, surgery via v-NOTES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic surgeryProcedure or surgery
the laparoscopic (LPC) arm, 21 patients will be assigned to conventional LPC and another 21 to robotic surgery, consecutively.
surgery via v-NOTESProcedure or surgery
surgery via v-NOTES
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic surgery | Active comparator | within the laparoscopic (LPC) arm, 21 patients will be assigned to conventional LPC and another 21 to robotic surgery, consecutively. Receives: Procedure: Laparoscopic surgery |
| surgery via v-NOTES | Experimental | surgery via v-NOTES Receives: Procedure: surgery via v-NOTES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Perioperative
Secondary outcomes (6)
AGE
Number of years
Measured: Day 1
Body Mass Index
numerical variable measured in "Kg/m2
Measured: Day 1
times spent in surgical techniques
number of minutes the surgery lasts
Measured: 1 day post surgery
Measurement of post-surgical pain
using the Visual Analog Scale (VAS) in the immediate postoperative period It consists of a 10-centimeter straight line, where one end represents the absence of pain (0) and the other, the worst pain imaginable (10).
Measured: 6 and 24 hours after the intervention
Study of overall patient satisfaction upon hospital discharge
Study of overall patient satisfaction upon hospital discharge: "SERVQHOS (quality of hospital services) a questionnaire to assess the perceived quality of hospital care through 20 items across 5 dimensions, each item is rated using a Likert-type(1-7) scale allowing free subjective evaluation.
Measured: Trough study completion, an average of a1 year
Study of patient quality of life before and one month after surgery
SF12 V2 Quality of Life Questionnaire"SF-12v2 is a shortened form (12 items) of the SF-36v2 Health Survey. (minimum 20 points maximum 60 points)
Measured: 0, 30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start11 Jul 2022
- Primary completion27 May 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, open-label, longitudinal, randomized, longitudinal, blind-blind third-party (observer-blind)
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafael Guijarro Campillo, MD, Principal investigator, HCUVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074067
- Sponsor's protocol ID
- 2022-4-5-HCUVA
- Acronym
- ENOLA
- Status last verified
- Jul 2025
- First submitted
- 27 Jun 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- V-Notes Hysterectomy in Patients With Endometrial cáncer Compared With Laparoscopic Surgery (Robotically Assisted or Not): ENOLA TRIAL
- ClinicalTrials.gov ID
- NCT07074067
- Acronym / sponsor ID
- ENOLA / 2022-4-5-HCUVA
- Conditions
- Endometrial Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUniversity, hospital or other
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, open-label, longitudinal, randomized, longitudinal, blind-blind third-party (observer-blind)
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic surgery | Active comparator | Procedure: Laparoscopic surgerywithin the laparoscopic (LPC) arm, 21 patients will be assigned to conventional LPC and another 21 to robotic surgery, consecutively. |
| surgery via v-NOTES | Experimental | Procedure: surgery via v-NOTESsurgery via v-NOTES |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic surgerythe laparoscopic (LPC) arm, 21 patients will be assigned to conventional LPC and another 21 to robotic surgery, consecutively. | Procedure or surgery | Laparoscopic surgery |
| surgery via v-NOTESsurgery via v-NOTES | Procedure or surgery | surgery via v-NOTES |
Primary outcome
Time taken to perform surgery
Time frame: Perioperative
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
6 secondary outcomes
AGE
Time frame: Day 1
Body Mass Index
Time frame: Day 1
times spent in surgical techniques
Time frame: 1 day post surgery
Measurement of post-surgical pain
Time frame: 6 and 24 hours after the intervention
Study of overall patient satisfaction upon hospital discharge
Time frame: Trough study completion, an average of a1 year
Study of patient quality of life before and one month after surgery
Time frame: 0, 30 days post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael Guijarro Campillo, MD principal investigator
HCUVA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic surgery and surgery via v-NOTES in people with Endometrial Adenocarcinoma, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time taken to perform surgery (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.