Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length

Study Overview
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Brief Summary
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CavatermTM is a second-generation thermal balloon ablation device in the management of menorrhagia. The purpose of this study is to investigate the success (questionnaire) of CavatermTM dependent on uterus probe length, especially corpus probe length, which is measured during surgery.

Official Title
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Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length, a Questionnaire Investigation on 290 Patients

Conditions
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Menorrhagia

Intervention / Treatment
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* Device: Thermal Balloon Endometrial Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CavatermTM operation because of menorrhagia timeframe: January 2006 till August 2009 older than 29 years and younger than 56 years Exclusion Criteria: pregnancy fragmentary filled questionnaire more than 1 CavatermTM operation

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Thermal Balloon Endometrial Ablation|Thermal Balloon Endometrial Ablation for 10 minutes after curettage|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postsurgical change in bleeding patterns dependent on cavum probe length. | Success is defined as a-, hypo- or eumenorrhoea, regular cycle, reduction of dysmenorrhoea. | Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year. | 
| Postsurgical change in patient satisfaction dependent on cavum probe length. | The questionnaire will ask for satisfaction and recommendation to the best friend. | Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postsurgical change in dyspareunia | The questionnaire will ask for pre- and postsurgical dyspareunia. | A questionnaire will be sent in September 2010, at least after one postsurgical year. | 
| Postsurgical change in Premenstrual Syndrome | The questionnaire will ask for pre- and postsurgical Premestrual Syndrome. | A questionnaire will be sent in September 2010, at least after one postsurgical year. | 
| Prevention of further gynaecological therapies | The questionnaire will ask for postsurgical hysterectomy and further medications. | A questionnaire will be sent in September 2010, at least after one postsurgical year. | 
| Improvement of quality of life | The questionnaire will ask for postsurgical quality of life. | A questionnaire will be sent in September 2010, at least after one postsurgical year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menorrhagia, dysfunctional uterine bleeding, endometrial ablation, cavatermTM, probe