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

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

CUMNDHTL

Scientific title:

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

Acronym of Scientific Title:

CUMNDHTL

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Cuban Ministry of Public Health (MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Luis

Midle name:

Gustavo

Last name:

Garcia Bannos

Medical Specialty :

Obstetric and Gynecology Specialist. Second degree

Affiliation:

National Center for Minimal Access Surgery

Postal address:

Calle Parraga #215, entre San Mariano y Vista Alegre, La Vibora, 10 de Octubre

City:

Havana

País:

Cuba

Zip Code:

10700

Telephone:

+53-76400179

Email address:

luisgustavo@infomed.sld.cu [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

National Center for Minimal Access Surgery, August 1th, 2016

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

01/03/2017

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Benign and premalignant gynecological pathologies of the uterus

Health condition(s) code:

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Health condition keyword:

Benign gynecological pathologies of the uterus,

Premalignant 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.

Intervention code:

Hysterectomy

Laparoscopy

Gynecologic Surgical Procedures

Minimally Invasive Surgical Procedures

Intervention keyword:

Uterine manipulator Clermont-Ferrand

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

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.

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Female

Minimum age:

18 years

Maximum age:

None

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 conﬁrmed gynecological cancer. 3. Patients with contraindication for laparoscopic surgery. 4. Anesthetic contraindication (ASA IV y V).

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Single Blind

Control group:

Active

Study design:

Parallel

Phase:

Target sample size:

100

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Luis

Middle Name:

Gustavo

Last Name:

Garcia Bannos

Specialty:

Obstetric and Gynecology Specialist. Second degree

Affiliation:

The Minimal Access Surgery National Centre

Postal Address:

Calle Parraga 215, entre San Mariano y Vista Alegre. La Vibora. 10 de Octubre

City:

Havana

País:

Cuba

Zip Code:

10700

Telephone:

+537-6400179

Email :

luisgustavo@infomed.sld.cu [1]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Luis

Middle Name:

Gustavo

Last Name:

Garcia Bannos

Specialty:

Obstetric and Gynecology Specialist. Second degree

Affiliation:

The Minimal Access Surgery National Center

Postal Address:

Calle Parraga 215, entre San Mariano y Vista Alegre. La Vibora. 10 de Octubre.

City:

Havana

País:

Cuba

Zip Code:

10700

Telephone:

+537-6400179

Email :

luisgustavo@infomed.sld.cu [1]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000235

Date of Registration in Primary Registry:

10/02/2017

Record Verification Date:

2017/02/10

Next update date:

2018/02/10

Link to the spanish version:

Click here [2]