Totally Laparoscopic Hysterectomy with Single-Port Access. Validation of a new technique in Cuba.
Phase 3
Recruiting
- Conditions
- Benign and premalign gynecological conditions of the uterus
- Registration Number
- RPCEC00000176
- Lead Sponsor
- ational Center for Minimal Access Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 180
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. Patients in whom have weight of uterus measure by preoperative ultrasound findings up 280 g.
4. Anesthetic evaluation ASA I and II.
5. Median body mass index lower than 35.
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).
5. Patients that refuse the treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Success on the procedures of laparoscopic hysterectomy (Success on the procedures: Yes, No). Measuring time: at the end of surgical procedure. <br>Postoperative pain (Pain after procedures using a Visual Analogue Scale). Measuring time: at 6, 24 hours and 15 days after procedure. <br>Aesthetics results (Satisfaction with scar aesthetics using a Visual Analogue Scale). Measuring time: 30 days after procedure.<br>
- Secondary Outcome Measures
Name Time Method Postoperative and intraoperative complications (Yes, No). Measuring time: 30 days after procedure. <br>Dead (Yes, No). Measuring time: 30 days after procedure. <br>Operative time (Time of the procedures in minutes). Measuring time: at the end of surgical procedure. <br>Length of hospital stays (Duration, in days, of hospital stay). Measuring time: at leaving the hospital.<br>