Endometrial tissue ablation: a clinical trial.
Completed
- Conditions
- Dysfunctional uterine bleeding
- Registration Number
- NL-OMON22028
- Lead Sponsor
- Channa Klein; J.Kleijn@mmc.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 160
Inclusion Criteria
1. Refractory menorrhagia with no definable organic cause (dysfunctional uterine bleeding);
2. Ages over 25 years old;
Exclusion Criteria
1. Presence of bacteremia, sepsis, or other active systemic infection;
2. Active or recurrent chronic pelvic inflammatory disease;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patients satisfaction:<br /><br>At each follow up visit/ telephone call patients satisfaction was noted. Patients can express their level satisfaction by using - completely satisfied, satisfied, doubtful satisfied or not satisfied.<br>It¡¯s also noted if any kind of reintervention is performed, such as the use of oral contraceptives or surgery.
- Secondary Outcome Measures
Name Time Method 1. Quality of life:<br /><br>All patients are asked to complete quality of life questionnaires at baseline, at two days, six weeks, three months, six months and twelve months after surgery. We evaluate quality of life with the medical outcomes study SF 36, the Rotterdam symptom checklist and a structured clinical history questionnaire;<br /><br>2. Amennorhoea:<br /><br>At each follow up visit/ telephone call duration of menstruation, dysmennorhoea and presence of clots are registered. Patients also complete a pictorial chart.