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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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RPCEC |
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Last refreshed on:
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1 April 2024 |
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Main ID: |
RPCEC00000176 |
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Date of registration:
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22/04/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Totally Laparoscopic Hysterectomy with Single-Port Access. Validation of a new technique in Cuba.
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Scientific title:
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Totally Laparoscopic Hysterectomy with Single-Port Access. Validation of a new technique in Cuba. |
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Date of first enrolment:
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05/01/2015 |
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Target sample size:
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180 |
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Recruitment status: |
Recruiting |
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URL:
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https://rpcec.sld.cu/en/trials/RPCEC00000176-En |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized controlled trial. Masking: Single Blind. Control group: Active. Assignment: Parallel. Purpose: Treatment
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Phase:
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3
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Countries of recruitment
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Cuba
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Contacts
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Name:
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Javier Ernesto
Barreras Gonzalez |
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Address:
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Calle Parraga #215, entre San Mariano y Vista Alegre. La Vibora. 10 de Octubre.
10700
Havana
Cuba |
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Telephone:
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javier@cce.sld.cu |
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Email:
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Affiliation:
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The Minimal Access Surgery National Center |
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Name:
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Javier Ernesto
Barreras Gonzalez |
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Address:
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Calle Parraga #215, entre San Mariano y Vista Alegre. La Vibora. 10 de Octubre.
10700
Havana
Cuba |
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Telephone:
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Email:
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javier@cce.sld.cu |
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Affiliation:
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The Minimal Access Surgery National Centre |
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Key inclusion & exclusion criteria
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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 con?rmed gynecological cancer.
3. Patients with contraindication for laparoscopic surgery.
4. Anesthetic contraindication ( ASA IV y V).
5. Patients that refuse the treatment.
Age minimum:
18 years
Age maximum:
None
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Benign and premalign gynecological conditions of the uterus
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Intervention(s)
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Experimental group: Totally Laparoscopic Hysterectomy with Single-Port access.
Control group: Totally Laparoscopic Hysterectomy standard with multiple ports access.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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Cuban Ministry of Public Health (MINSAP)
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Ethics review
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Status:
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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