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

Medical University of Vienna290 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

290

Conditions

Menorrhagia

Interventions

Thermal Balloon Endometrial AblationDEVICE

Thermal Balloon Endometrial Ablation for 10 minutes after curettage

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Landesklinikum Thermenregion Neunkirchen

Neunkirchen, Lower Austria, Austria

Outcomes

Primary Outcomes

Postsurgical change in bleeding patterns dependent on cavum probe length.

Success is defined as a-, hypo- or eumenorrhoea, regular cycle, reduction of dysmenorrhoea.

Time frame: 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.

Time frame: Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year.

Secondary Outcomes

Postsurgical change in dyspareunia

The questionnaire will ask for pre- and postsurgical dyspareunia.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: A questionnaire will be sent in September 2010, at least after one postsurgical year.

Data from ClinicalTrials.gov

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