caesarean scar defect Niche
Conditions
Interventions
The intervention group will undergo a laparoscopic niche resection. This
procedure is standard care and will be performed by an experience gynaecologist
(> 200 previous laparoscopic niche resections
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - women 18 years or older - pre-menopausal (regular menstrual cyclus) - large, symptomatic niche after caeserean section
Exclusion criteria
Exclusion criteria: - Age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is number of days of uterine blood loss between two menstruation, six months after randomisation, using a validated blood loss calender to be filled in by the patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary outcomes are gynaecological complaints such as heavy and/or painful uterine blood loss. Patient satisfaction and quality-of-life. Surgical outcomes, niche characteristics, re-interventions, extra hormonal treatment or surgical interventions nine months after randomization. Medical consultations and costs. | — |
Countries
Netherlands
Outcome results
None listed