Clinical trial · Interventional
Save the Ovaries - Surgical Management of Simple Ovarian Cysts in Children and Adolescents
NCT06852313CI-TRIAL-00109703recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate which operative technique should be used for managing simple ovarian cysts in girls and adolescents. The two techniques that are being compared are laparoscopic cyst enucleation and laparoscopic cyst deroofing. The investigators will assess the effect of both techniques on the ovarian reserve and the risk of cyst recurrence.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cyst Benign | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic ovarian cyst surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ovarian Cyst Deroofing
- description
- The Ovarian cyst is deroofed with a specific, predefined technique: removal of a square of the cyst wall and overlying ovarian capsule of 16x16mm and suctioning of cyst contents.
- interventionNames
- Procedure: Laparoscopic ovarian cyst surgery
- type
- EXPERIMENTAL
- label
- Ovarian Cyst Enucleation
- description
- The ovarian cyst is enucleated by complete removal of the cyst lining with preservation of surrounding ovarian tissue.
- interventionNames
- Procedure: Laparoscopic ovarian cyst surgery
Primary outcomes (1)
- measure
- Postoperative change of AMH level
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.