V-Notes Hysterectomy in Patients With Endometrial cáncer Compared With Laparoscopic Surgery (Robo… (NCT07074067) | Clinical Trial Compass
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 range18 Years
SexFEMALE
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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…
What they're measuring
1
Time taken to perform surgery
Timeframe: Perioperative
Trial details
NCT IDNCT07074067
SponsorFundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia