Protocol Number: 09-CH-0085
Study Design: This is a clinic-based patient survey of prospectively recruited women undergoing a laparoscopy for symptoms suggestive of endometriosis or for tubal sterilization. Descriptive, as well as nested case-control studies will be conducted using information collected from patients in the registry to investigate the impact of endometriosis and associated symptoms, and test etiological hypotheses. Primary Outcome: The primary purpose of this survey is to collect systematic, comprehensive epidemiological information on the impact of endometriosis among women world-wide, in terms of prevalence, diagnostic delay, quality of life, economic effect indicators, health care utilization, and risk-factors. Secondary Outcomes: A secondary purpose of the register is to provide a frame-work for future follow-up studies of women diagnosed with endometriosis, allowing the investigation of indicators of effectiveness of different treatment options; long-term quality of life issues, as well as personal and economic (productivity) costs of endometriosis. The multi-center nature of the study should allow variability of endometriosis illness outcomes and associations to be assessed across participating countries. Statistical Methods: Basic descriptive analyses will include prevalence estimates according to different age and demographic characteristics, across countries. The analyses of most outcomes will be conducted by comparing women with endometriosis (cases) to those without (controls), both of which will have been recruited through the same process. To avoid bias, cases will be matched to controls on characteristics such as age, country of residence and clinic attended. The analysis of the data will take into consideration this matching; in addition, adjustment for symptoms for which the laparoscopy was indicated (pelvic pain, infertility) will be included. Continuous variables and categorical variables will be analyzed with the appropriate statistical tests. Duration of Patient Participation: Women are informed about the study at the consultation during which their laparoscopy is scheduled. If they accept to participate, they are asked to fill in an online questionnaire any time before their scheduled surgery. Unless they consent to being contacted sometime in the future for follow-up surveys, their active participation in the study ends. If they wish to participate in future surveys, they will be contacted at most every 1-2 years.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 05/05/2009
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