Autologous graft in extensive myomectomies

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000020
• Date of registration: 12/09/2008
• Primary sponsor: Provincial University Gynaeco-Obstetric Hospital “Mariana Grajales” of Santa Clara City, Villa Clara
• Public title: Autologous graft in extensive myomectomies
• Scientific title: Free autologous graft of striated muscle and omentum in extensive myomectomies
• Date of first enrolment: 01/12/1999
• Target sample size: 17
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000020-En
• Study type: Interventional
• Study design: Randomization: Nonrandomized Trial Blinding: Open. Placebo: Placebo Assignment: Other Purpose: Treatment Other design features: Historical control

Countries of recruitment

Cuba

Contacts

• Name: Dr. Pedro E Alemán Ramírez
• Affiliation: Provincial University Gynaeco-Obstetric Hospital “Mariana Grajales” Santa Clara

• Name: Dr. Pedro E Alemán Ramírez
• Affiliation: Provincial University Gynaeco-Obstetric Hospital “Mariana Grajales” Santa Clara .

Key inclusion & exclusion criteria

Inclusion criteria: - Diagnostic criteria: symptomatic 20 to 35 years of age women suffering from voluminous and/or multiple myomas with reproductive interest; voluntary principle and written consent – Inclusion particular criterium - Extensive myomectomy
Exclusion criteria: Uncontrollable hemostasis changing myomectomia into hysterectomy; diffuse uterine myomatosis; uterine malignant diseases; uterine adenomyosis; gynaecological infections; pelvic endometriosis.

Age minimum: 20 years
Age maximum: 35 years
Gender: Female

Health Condition(s) or Problem(s) studied

Abdominal myomectomy

Intervention(s)

An autologous transplant of striated muscle and omentum or epiploon is used in the defect produced by standard abdominal myomectomy with extensive loss of uterus tissue: 50% loss of myometrium and /or endometrium that does not admit anatomical or functional repairing.

Primary Outcome(s)

For measuring efficacy, Clinical and symptomatic improvement of the diseases after surgery in more than 80% of patients, Measurement time: 2 months. Reproductive achievement in 60% of patients after one year of avoiding pregnancy, Measurement time: 3 years. Security Criteria: occurrence of complications classified as moderate that can be immediately solved. WHO Report (1995), Measurement time: 1 month.

Secondary Outcome(s)

Improvement in quality of life, in the couple relationship and in the social field, Measurement time: 3 years

Secondary ID(s)

08310

Source(s) of Monetary Support

Budgeted unit Provincial University Gynaeco-Obstetric Hospital “Mariana Grajales” of Santa Clara City, Villa Clara.