Central American Research on Prophylactic Ovariectomy amongst Menopausal Wome

Not Applicable

• Conditions: Prophylactic ovariectomy; Surgery - Other surgery

• Registration Number: ACTRN12608000589381
• Lead Sponsor: The International Health Central American Institute Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 500

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mean well-being and quality of life scores. Researchers will interview each participant regarding their quality of life, using the MENCAV questionnaire.<br>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.[The questionnaire will be administered on five separate occasions<br>1) Pre-operatively<br>And<br>2) Post-operatively.<br>six months, then one, two and five years]

Secondary Outcome Measures

Name	Time	Method
requirement for further pelvic surgical intervention.[at five years after randomisation.]