No registrations found.
ID
Source
Brief title
Health condition
- Niche
- Cesarean section scar defect
- Gynaecological symptoms
- Laparoscopy
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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
Background summary
niche is a defect that can develop at the site a cesarean section scar. Approximately 60% of the women with aprevious cesarean section will develop such a niche. In 25% of the niches, a large symptomatic niche develops,with less than 3 mm of residual myometrium. This causes complaints such as abnormal uterine blood loss,dysmenorrhea, chronic pelvic pain and is related to infertility. Several hormonal therapies are available forgynecological complaints, such as oral anticonceptives, progesterone, intra-uterine device (IUD) with levenorgestrel. In case of failure of or contraindications to hormonal therapy, surgical intervention can be considered. Several innovative surgical therapies have been developed to treat niche-related symptoms, such as a laparoscopic niche resection. This treatment has been proven effective in the reduction of postmenstrual spotting and menstrual pain and its implementation in daily practice is increasing internationally. However,information on the effectiveness of this treatment in comparison with hormonal therapy in reduction of symptoms for women without a child wish, has not been studied yet. In the present study we aim to include women with a large niche and gynecological symptoms, randomize between a laparoscopic niche resection within 6 weeks(Intervention group) and hormonal therapy for nine months (Control group). After nine months, if the provided treatment is not effective enough, patients are eligible for additional surgical interventions.
Study objective
Laparoscopic niche-resection is a superior treatment for symptomatic niches compared with hormonal therapy.
Study design
- 3, 6 months
- follow up 12, 24 months
Intervention
Intervention: Laparoscopic niche resection performed within 6 weeks after randomization.
Control: Hormonal therapy (oral anticonceptives, progesterone, levenorgestrel IUD, GnRH agonist) for nine months.
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9534 |
| CCMO | NL73649.029.20 |
| OMON | NL-OMON54858 |