Hysteroscopic resection of uterine scar defects (niche) in patients with abnormal bleeding, a randomised controlled trial
Completed
- Conditions
- CS scar defectIsthmocele10013326
- Registration Number
- NL-OMON39029
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Patients with post menstrual spotting (more than 2 days or menstruation of at least 10 days) and a large niche(at least 2mm) with a residual myometrium more than 3 mm.
Exclusion Criteria
Patients aged below 18 or pregnant.
Other causes of postmenstrual spotting ( abnormalities in the uterine cavity)
Contraindications for general or spinal anesthesia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary: number of days with postmenstrual spotting in the first 6 months after<br /><br>randomization</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary: menstrual pattern (score card) and related pain (VAS) and<br /><br>disturbance (VAS), quality of life (SF36, EuroQol), patient satisfaction,<br /><br>sexual function (FSFI), medical consultation and medication use, complications,<br /><br>sick leave, and costs (diary) after 3, 6 and 12 months after randomization.<br /><br>Characterisitics of the niche (3 months after randomization, size/volume of the<br /><br>niche).</p><br>