Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000589381
Ethics application status
Not yet submitted
Date submitted
29/09/2008
Date registered
21/11/2008
Date last updated
21/11/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Central American Research on Prophylactic Ovariectomy amongst Menopausal Women
Scientific title
Prophylactic ovariectomy for well-being and the quality of life in menopausal women
Secondary ID [1] 737 0
Nil
Universal Trial Number (UTN)
Trial acronym
CARPOMW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prophylactic ovariectomy 3854 0
Condition category
Condition code
Surgery 3941 3941 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The term prophylactic ovariectomy implies that the ovaries are normal at the time of the hysterectomy and that it is performed for possible future benefit.
Usually the decision to remove or preserve the ovaries is based on the surgeon’s recommendations or by request of the patient. Many clinics say that 45 years old is the age at which a prophylactic ovariectomy is strongly recommended. Also, the predominant teaching is that a prophylactic ovariectomy in patients with low risk of ovarian cancer must be avoided in women under 40 years old. It is routinely performed in women over 50 years old and is individualized in between.
Data gathered from the Centers for Disease Control and Prevention in the United States in between the years of 1988 and 1993, reported that ovarian retention only happens in about 40% to 50% of the patients who undergo a hysterectomy at the age of 40 or more. Conservative numbers suggest that about 300,000 women suffer from bilateral prophylactic ovariectomy each year in the same country.
In this trial, intervention group will undergo a hysterectomy without bilateral ovariectomy while the control group will have a bilateral ovariectomy (current clinical practice) during the hysterectomy.
Intervention code [1] 3477 0
Treatment: Surgery
Comparator / control treatment
Perform a prophylactic ovariectomy at the time of the hysterectomy.
Control group
Active

Outcomes
Primary outcome [1] 4839 0
mean well-being and quality of life scores. Researchers will interview each participant regarding their quality of life, using the MENCAV questionnaire.
This questionnaire is the first Spanish questionnaire designed to assess the quality of life in menopausal women. Analysis of the reliability and internal validity of the MENCAV suggests that the questionnaire has demonstrated a high degree of internal consistency (42). It has been developed from an aggregate of 213 items that after a process of reduction and testing was left with 37 items structured in 5 dimensions: physical health (10 items), psychological health (9 items), sexual relations (4 items), couple relationship (4 items), and social support (10 items). It is a valid, reliable instrument of quick administration.
Timepoint [1] 4839 0
The questionnaire will be administered on five separate occasions
1) Pre-operatively
And
2) Post-operatively.
six months, then one, two and five years
Secondary outcome [1] 8166 0
requirement for further pelvic surgical intervention.
Timepoint [1] 8166 0
at five years after randomisation.

Eligibility
Key inclusion criteria
A woman will be eligible for inclusion in this study only if all of the following criteria apply
1
Women about to have an elective hysterectomy for benign causes shall be considered.
2.
Woman has provided written informed consent to participate in the study.
Minimum age
45 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
A woman will not be eligible for inclusion in this study if any of the following criteria apply.
1.
The woman is currently participating or has participated in an investigational trial during the previous four months
2.
The woman in the judgment of the principal investigator, is unlikely to be able to be prospectively followed for a five year period
3.
The woman has a previous family history of first grade ovarian cancer
4.
The woman has antecedents of psychiatric disease and the use of psychotropic drugs.
5.
The woman requires a hysterectomy due to the presence of neoplasia.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be identified and potentially recruited through the pre-operational gynecological evaluations in out patient clinics of the participant hospital centers. Once the participants are identified and her eligibility has been confirmed, the informed consent will be sought. Once a participant has signed the informed consent sheet, they will be randomized.
the investigator will staple the envelope (closed), that contains the letter corresponding to the assigned group, to the inner part of the file’s cover to avoid it from getting lost during its handling by the nurse staff, filers or the rest of administrative workers at the day of the surgery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Web based software shall be used to complete the randomization process.
The participants shall be randomized from national coordination centers that will be located in either the epidemiology unit of the “Primero de Mayo” General Hospital in San Salvador or in the “Dr. A. Carit” Women’s Hospital in San José, Costa Rica. The operation centre will be located at IHCAI FOUNDATION in San Jose, Costa Rica.
The sequence generation will be develop using a computer program.
Every randomized participant will be analyzed in the group in which they were assigned following the principles of intent to treat analysis.
Randomisation of the participants will be completed as near to the date of surgery as possible to reduce the number of study withdrawals.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment outside Australia
Country [1] 1235 0
Costa Rica
State/province [1] 1235 0
Country [2] 1236 0
El Salvador
State/province [2] 1236 0
Country [3] 1237 0
Panama
State/province [3] 1237 0
Country [4] 1238 0
Uruguay
State/province [4] 1238 0

Funding & Sponsors
Funding source category [1] 3938 0
Charities/Societies/Foundations
Name [1] 3938 0
The International Health Central American Institute Foundation
Country [1] 3938 0
Costa Rica
Primary sponsor type
Charities/Societies/Foundations
Name
The International Health Central American Institute Foundation
Address
MAIN OFFICE P.O. Box 1677-2100
SAN JOSE, COSTA RICA
Country
Costa Rica
Secondary sponsor category [1] 3532 0
Other Collaborative groups
Name [1] 3532 0
Grupo de apoyo en medicina basada en la evidencia
Address [1] 3532 0
P.O. BOX 1677-2100 SAN JOSE COSTA RICA
Country [1] 3532 0
Costa Rica

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6005 0
San Salvador
Ethics committee address [1] 6005 0
Ethics committee country [1] 6005 0
Date submitted for ethics approval [1] 6005 0
10/11/2008
Approval date [1] 6005 0
Ethics approval number [1] 6005 0

Summary
Brief summary
To establish the potential harms or benefits of performing a prophylactic ovariectomy in conjunction with a hysterectomy in postmenopausal women.
The objectives are: to disprove the following null hypothesis’s
1. The well-being and the quality of life of post menopausal women shall not be adversely affected in those who have a hysterectomy in conjunction with ovariectomy compared to those who have a hysterectomy alone.
2. The requirement for further pelvic surgical intervention in post menopausal women who have a hysterectomy in conjunction with ovariectomy is not greater compared to those who have a hysterectomy alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28984 0
Address 28984 0
Country 28984 0
Phone 28984 0
Fax 28984 0
Email 28984 0
Contact person for public queries
Name 12141 0
Dr. Leonardo Orozco
Address 12141 0
P.O. Box 11619-1000, San José
Country 12141 0
Costa Rica
Phone 12141 0
506 83638584
Fax 12141 0
(506) 22263047
Email 12141 0
[email protected]
Contact person for scientific queries
Name 3069 0
Dr. Leonardo Orozco
Address 3069 0
P.O. Box 11619-1000, San José
Country 3069 0
Costa Rica
Phone 3069 0
506 83638584
Fax 3069 0
(506) 22263047
Email 3069 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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