Cuban uterine manipulator, new device for the hysterectomy totally laparoscopic.

Phase 3

Conditions: Benign and premalignant gynecological pathologies of the uterus
Benign gynecological pathologies of the uterus,
Premalignant gynecological pathologies of the uterus
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases

Registration Number: RPCEC00000235

Lead Sponsor: ational Center for Minimal Access Surgery

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Female

Target Recruitment: 100

Inclusion Criteria

1. Patients female older than 18 years-old.
2. Patients with the diagnostic of the benign and premalign gynecological conditions of the uterus and indication of the hysterectomy.
3 No surgical diseases that state an associated surgical procedure.
4. Anesthetic evaluation ASA I-II-III.
5. Patients that they consent to being a part of the study. (informed consent).

Exclusion Criteria

1. Patients with the indication of the vaginal hysterectomy for uterus prolapse.
2. Patients with con?rmed gynecological cancer.
3. Patients with contraindication for laparoscopic surgery.
4. Anesthetic contraindication (ASA IV y V).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Success on the procedure (Procedure realized: Yes, No). Measuring time: at the end of surgical procedure.<br>2. Feasibility and security of the designed rigid system (Complications or phenomena that appear due to the use of the instrument), Measuring time: at the end of surgical procedure. <br>3. Adverse effects of the neumo ocluccive globe designed. (Complications or phenomena that appear due to the use of the instrument). Measuring time: at the end of surgical procedure. <br>4. Applied force when using the manipulator (Surgical technique variation suggested according to the type of manipulator used). Measuring time: at the end of surgical procedure. <br>

Secondary Outcome Measures

Name	Time	Method
1. Median body mass index (according to weight and size calculation). Measuring time: Preoperative. <br>2. Weight of uterus (measured in gr according to measure by ultrasound) Measuring time: Preoperative. <br>3. Transoperative bleeding (amount of blood collected measured in ml by self aspiration) Measuring time: at the end of surgical procedure. <br>4. Operative time (Time of the procedures in minutes). Measuring time: at the end of surgical procedure. <br>5. Postoperative pain (Pain after procedures using a visual analogue scale). Measuring time: 6, 24 hours after procedure.<br>6. Postoperative and intraoperative complications (Yes, No).Measuring time: 7, 30 and 45 days after procedure. <br>7. Hospital stays (Length of hospital stay, measured in days). Measuring time: at leaving the hospital.