Autologous graft in extensive myomectomies

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:

Free autologous graft of striated muscle and omentum in extensive myomectomies

Secondary indentifying numbers:

08310

Issuing authority of the secondary identifying numbers:

Provincial University Gynaeco-Obstetric Hospital “Mariana Grajales”, Villa Clara

Source(s) of monetary or material support:

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

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:

Pedro E.

Midle name:

Last name:

Alemán Ramírez

Medical Specialty :

Specialist in Gynecology

Affiliation:

Provincial University Gynaeco-Obstetric Hospital “Mariana Grajales”

Postal address:

Avenida 26 de Julio. Reparto Escambray, Villa Clara

City:

Santa Clara

País:

Cuba

Zip Code:

50200

Telephone:

+53-42272012

Email address:

aleman@capiro.vcl.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:

Provincial University Gynaeco-Obstetric Hospital “Mariana Grajales”; December 16th , 1996.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

01/12/1999

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:

Abdominal myomectomy

Health condition(s) code:

Leiomyoma

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Neoplasms, Muscle Tissue

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

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.

Intervention code:

Uterine Myomectomy

Transplantation, Autologous

Muscle, Striated

Omentum

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):

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.

Key secondary outcomes:

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

Selection criterias

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

Gender:

Female

Minimum age:

20 years

Maximum age:

35 years

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.

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:

Non-randomized controlled trial

Masking:

Open

Control group:

Placebo

Study design:

Other

Other design:

Historical control

Phase:

Target sample size:

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:

Pedro

Middle Name:

Last Name:

Alemán Ramírez

Specialty:

Specialist in Gynecology

Affiliation:

Provincial University Gynaeco-Obstetric Hospital “Mariana Grajales”

Postal Address:

Avenida 26 de julio. Reparto Escambray, Santa Clara

City:

Villa Clara

País:

Cuba

Zip Code:

50200

Telephone:

27 2012

Email :

aleman@capiro.vcl.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:

Pedro

Middle Name:

Last Name:

Alemán Ramírez

Specialty:

Specialist in Gynecology

Affiliation:

Provincial University Gynaeco-Obstetric Hospital “Mariana Grajales”

Postal Address:

Avenida 26 de julio. Reparto Escambray, Santa Clara

City:

Villa Clara

País:

Cuba

Zip Code:

50200

Telephone:

27 2012

Email :

aleman@capiro.vcl.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:

RPCEC00000020

Date of Registration in Primary Registry:

2008-09-12

Record Verification Date:

2017/01/16

Next update date:

2018/01/16

Link to the spanish version:

Click here [2]