Save the Ovaries - Surgical Management of Simple Ovarian Cysts in Children and Adolescents
NCT ID: NCT06852313
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2026-01-14
2028-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ovarian Cyst Deroofing
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.
Laparoscopic ovarian cyst surgery
Laparoscopic ovarian cyst surgery is any surgery with the goal of removal or drainage of an ovarian cyst. The exact surgical technique will be predefined by randomization.
Ovarian Cyst Enucleation
The ovarian cyst is enucleated by complete removal of the cyst lining with preservation of surrounding ovarian tissue.
Laparoscopic ovarian cyst surgery
Laparoscopic ovarian cyst surgery is any surgery with the goal of removal or drainage of an ovarian cyst. The exact surgical technique will be predefined by randomization.
Interventions
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Laparoscopic ovarian cyst surgery
Laparoscopic ovarian cyst surgery is any surgery with the goal of removal or drainage of an ovarian cyst. The exact surgical technique will be predefined by randomization.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Year
18 Years
FEMALE
No
Sponsors
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University Children's Hospital Basel
OTHER
University Children's Hospital, Zurich
OTHER
Responsible Party
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Uchenna Kennedy
Principal Investigator
Locations
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University Children's Hospital Basel
Basel, , Switzerland
University Children's Hospital Zurich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SAVEOVPRO2025
Identifier Type: -
Identifier Source: org_study_id
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