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

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.

Scientific title:

Secondary indentifying numbers:

cncma006

Issuing authority of the secondary identifying numbers:

National Center for Minimal Access Surgery

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:

Javier

Midle name:

Ernesto

Last name:

Barreras Gonzalez

Medical Specialty :

General Surgery Specialist. Second degree

Affiliation:

National Center for Minimal Access Surgery

Postal address:

Calle Párraga #215, entre San Mariano y Vista Alegre, La Víbora, 10 de Octubre

City:

La Habana

Country:

Cuba

Zip Code:

10700

Telephone:

+53-76400179

Email address:

javier@cce.sld.cu [1]

javier.barrera@infomed.sld.cu [2]

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, October 1th, 2013

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

05/01/2015

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 premalign gynecological conditions of the uterus

Intervention(s):

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

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):

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.

Key secondary outcomes:

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.

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. 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 conﬁrmed gynecological cancer. 3. Patients with contraindication for laparoscopic surgery. 4. Anesthetic contraindication ( ASA IV y V). 5. Patients that refuse the treatment.

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:

180

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:

Javier

Middle Name:

Ernesto

Last Name:

Barreras Gonzalez

Specialty:

General Surgery 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

Country:

Cuba

Zip Code:

10700

Telephone:

+537-6400179

Email :

javier@cce.sld.cu [1]

javier.barrera@infomed.sld.cu [2]

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:

Javier

Middle Name:

Ernesto

Last Name:

Barreras Gonzalez

Specialty:

General Surgery 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

Country:

Cuba

Zip Code:

10700

Telephone:

+537-6400179

Email :

javier@cce.sld.cu [1]

javier.barrera@infomed.sld.cu [2]

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:

RPCEC00000176

Date of Registration in Primary Registry:

22/04/2014

Record Verification Date:

2016/03/05

Next update date:

2017/03/05

Link to the spanish version:

Click here [3]