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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
the laparoscopic (LPC) arm, 21 patients will be assigned to conventional LPC and another 21 to robotic surgery, consecutively.
surgery via v-NOTES
HCUVA
Murcia, Murcia, Spain
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
Time frame: Perioperative
AGE
Number of years
Time frame: Day 1
Body Mass Index
numerical variable measured in "Kg/m2
Time frame: Day 1
times spent in surgical techniques
number of minutes the surgery lasts
Time frame: 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).
Time frame: 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.
Time frame: 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)
Time frame: 0, 30 days post surgery
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