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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic surgery | Active Comparator | within the laparoscopic (LPC) arm, 21 patients will be assigned to conventional LPC and another 21 to robotic surgery, consecutively. |
|
| surgery via v-NOTES | Experimental | surgery via v-NOTES |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic surgery | Procedure | the laparoscopic (LPC) arm, 21 patients will be assigned to conventional LPC and another 21 to robotic surgery, consecutively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| AGE | Number of years | Day 1 |
| Body Mass Index | numerical variable measured in "Kg/m2 | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant Women
Women with endometrial cancer
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| Name | Affiliation | Role |
|---|---|---|
| Rafael Guijarro Campillo, MD | HCUVA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HCUVA | Murcia | Murcia | 30120 | Spain |
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prospective, open-label, longitudinal, randomized, longitudinal, blind-blind third-party (observer-blind)
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| surgery via v-NOTES | Procedure | surgery via v-NOTES |
|
| times spent in surgical techniques | number of minutes the surgery lasts | 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). | 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. | 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) | 0, 30 days post surgery |
| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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