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

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000235
• Date of registration: 10/02/2017
• Prospective Registration: Yes
• Primary sponsor: National Center for Minimal Access Surgery
• Public title: Cuban uterine manipulator, new device for the hysterectomy totally laparoscopic.
• Scientific title: Cuban uterine manipulator, new device for the hysterectomy totally laparoscopic. - CUMNDHTL
• Date of first enrolment: 01/03/2017
• Target sample size: 100
• Recruitment status: Pending
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000235-En
• Study type: Interventional
• Study design: Allocation: Randomized controlled trial. Masking: Single Blind. Control group: Active. Assignment: Parallel. Purpose: Treatment
• Phase: 3

Countries of recruitment

Cuba

Contacts

• Name: Luis Gustavo Garcia Bannos
• Affiliation: The Minimal Access Surgery National Centre

• Name: Luis Gustavo Garcia Bannos
• Affiliation: The Minimal Access Surgery National Center

Key inclusion & exclusion 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: 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).

Age minimum: 18 years
Age maximum: None
Gender: Female

Health Condition(s) or Problem(s) studied

Female Urogenital Diseases

Premalignant gynecological pathologies of the uterus

Genital Diseases, Female

Uterine Diseases

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

Premalignant gynecological pathologies of the uterus

Benign gynecological pathologies of the uterus,

Intervention(s)

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

Hysterectomy

Laparoscopy

Gynecologic Surgical Procedures

Uterine manipulator Clermont-Ferrand

Minimally Invasive Surgical Procedures

Primary Outcome(s)

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.

Secondary Outcome(s)

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.

Secondary ID(s)

Not applicable

Source(s) of Monetary Support

Cuban Ministry of Public Health (MINSAP)

Secondary Sponsor(s)

Not applicable