SYMPRES study
- Conditions
- - Niche- Cesarean section scar defect- Gynaecological symptoms- Laparoscopy
- Registration Number
- NL-OMON28362
- Lead Sponsor
- VU medical center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
women 18 years or older
- pre-menopausal (regular menstrual cyclus)
- large, symptomatic niche after caeserean section
Exclusion Criteria
- Age <18 years
- Pregnancy
- Desire to become pregnant within one year
- Contraindications for general anesthesia,
- (Suspected) malignancy,
- Uterine of cervical polyps
- Submucosal fibroids,
- Atypical endometrial cells
- Cervical dysplasia,
- Cervical or pelvic infection,
- Hydrosalphinx
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome is number of days of uterine blood loss between two menstruation, six months after randomisation, using avalidated blood loss calender to be filled in by the patient.
- Secondary Outcome Measures
Name Time Method Secundary outcomes are gynaecological complaints such as heavy and/or painful uterine blood loss. Patient satisfaction andquality-of-life. Surgical outcomes, niche characteristics, re-interventions, extra hormonal treatment or surgical interventions ninemonths after randomization. Medical consultations and costs