Symptomatic niches for laparoscopic niche resection, a randomized clinical trial

Recruiting

• Conditions: caesarean scar defect; Niche; 10013326

• Registration Number: NL-OMON54858
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• 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
<p>Primary outcome is number of days of uterine blood loss between two<br /><br>menstruation, six months after randomisation, using a validated blood loss<br /><br>calender to be filled in by the patient.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary outcomes are gynaecological complaints such as heavy and/or painful<br /><br>uterine blood loss. Patient satisfaction and quality-of-life. Surgical<br /><br>outcomes, niche characteristics, re-interventions, extra hormonal treatment or<br /><br>surgical interventions nine months after randomization. Medical consultations<br /><br>and costs.</p><br>