Surgical options to preserve ovaries in girls and adolescents with simple ovarian cysts
Save the Ovaries - Surgical Management of Simple Ovarian Cysts in Children and Adolescents
This trial will see if laparoscopic cyst enucleation or laparoscopic cyst deroofing better preserves ovarian reserve and lowers cyst recurrence in girls and adolescents with simple ovarian cysts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | Female |
| Sponsor | University Children's Hospital, Zurich Academic / other |
| Locations | 2 sites (Basel and 1 other locations) |
| Trial ID | NCT06852313 on ClinicalTrials.gov |
What this trial studies
Girls and adolescents (12 months to 18 years) with symptomatic or persistent simple ovarian cysts of 4 cm or larger will undergo one of two laparoscopic procedures: cyst enucleation or cyst deroofing. Investigators will follow ovarian function markers and monitor for cyst recurrence after surgery. The study focuses on surgical technique choice and its effects on ovarian reserve and the likelihood of cyst coming back. Enrollment and procedures take place at pediatric surgical centers in Zurich and Basel.
Who should consider this trial
Good fit: Ideal candidates are girls and adolescents aged 12 months to 18 years with simple ovarian cysts ≥4 cm that require surgery, with parental consent and appropriate language ability.
Not a fit: Patients younger than 12 months, those with complex or suspicious cysts, paraovarian cysts, or medical contraindications to enucleation are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could help surgeons choose the technique that best preserves ovarian function and reduces repeat operations for young patients.
How similar studies have performed: Laparoscopic enucleation and deroofing have been used in adults and reported in pediatric case series, but high-quality comparative data specifically in children and adolescents remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Symptomatic simple cysts ≥ 4 cm with indication for surgical intervention * Asymptomatic cysts ≥ 4 cm, with surgical indication due to persistence or increase in size * Asymptomatic cysts ≥ 4 cm with other pathology as surgical indication, if known preoperatively * Age 12 months - 18 years * Parents/legal custodian and patient give consent, for patients unable to consent due to their health condition or developmental status they show no signs of unwillingness to participate * Symptomatic simple cysts ≥ 4 cm with indication for surgical intervention on both ovaries (each ovary will count as one) Exclusion Criteria: * Neonatal ovarian cysts (age \<12 months) * Age \>18 years * Complex cysts (with solid components, e.g., Teratoma, risk or suspicion of malignancy) * Paratubar/paraovarian cysts * Medical reason that precludes cyst enucleation (e.g. severe coagulopathy) * Neither signed informed consent form or inadequate german, french or english language skills to give informed consent
Where this trial is running
Basel and 1 other locations
- University Children's Hospital Basel — Basel, Switzerland (Recruiting)
- University Children's Hospital Zurich — Zurich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Uchenna Kennedy, MD
- Email: uchenna.kennedy@kispi.uzh.ch
- Phone: 0041 2494949
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.