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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000235

Enrollment

100

Registered

2017-02-10

Start date

2017-03-01

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 premalignant gynecological pathologies of the uterus Benign gynecological pathologies of the uterus, Premalignant gynecological pathologies of the uterus

Interventions

Group I - Cuban uterine manipulator (experimental): Totally Laparoscopic Hysterectomy using the uterine manipulator created in Cuba. Group II - Clermont-Ferrand Uterine manipulator (control): Totall

Laparoscopy

Gynecologic Surgical Procedures

Minimally Invasive Surgical Procedures

Hysterectomy

Uterine manipulator Clermont-Ferrand

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 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

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).

Design outcomes

Secondary

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

Measure

Time frame

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

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Primary

Measure	Time frame
1. Success on the procedure (Procedure realized: Yes, No). Measuring time: at the end of surgical procedure. 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. 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. 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.	—

Measure

Time frame

1. Success on the procedure (Procedure realized: Yes, No). Measuring time: at the end of surgical procedure. 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. 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. 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.

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Countries

Cuba

Contacts

Public ContactLuis Garcia Bannos

The Minimal Access Surgery National Centre

luisgustavo@infomed.sld.cu

Outcome results

None listed

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