Totally Laparoscopic Hysterectomy with Single-Port Access. Validation of a new technique in Cuba.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000176

Enrollment

180

Registered

2014-04-22

Start date

2015-01-05

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign and premalign gynecological conditions of the uterus

Interventions

Experimental group: Totally Laparoscopic Hysterectomy with Single-Port access. Control group: Totally Laparoscopic Hysterectomy standard with multiple ports access.

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Success on the procedures of laparoscopic hysterectomy (Success on the procedures: Yes, No). Measuring time: at the end of surgical procedure. Postoperative pain (Pain after procedures using a Visual Analogue Scale). Measuring time: at 6, 24 hours and 15 days after procedure. Aesthetics results (Satisfaction with scar aesthetics using a Visual Analogue Scale). Measuring time: 30 days after procedure.	—

Measure

Time frame

Success on the procedures of laparoscopic hysterectomy (Success on the procedures: Yes, No). Measuring time: at the end of surgical procedure. Postoperative pain (Pain after procedures using a Visual Analogue Scale). Measuring time: at 6, 24 hours and 15 days after procedure. Aesthetics results (Satisfaction with scar aesthetics using a Visual Analogue Scale). Measuring time: 30 days after procedure.

—

Secondary

Measure	Time frame
Postoperative and intraoperative complications (Yes, No). Measuring time: 30 days after procedure. Dead (Yes, No). Measuring time: 30 days after procedure. Operative time (Time of the procedures in minutes). Measuring time: at the end of surgical procedure. Length of hospital stays (Duration, in days, of hospital stay). Measuring time: at leaving the hospital.	—

Countries

Cuba

Contacts

Public ContactJavier Barreras Gonzalez

The Minimal Access Surgery National Centre

javier@cce.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026