Save the Ovaries - Surgical Management of Simple Ovarian Cysts in Children and Adolescents

University of Zurich (UZH)

Status: Enrolling

Conditions: Ovarian Cyst Benign

Treatments: Procedure: Laparoscopic ovarian cyst surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06852313

SAVEOVPRO2025

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Ovarian Cyst Deroofing

Experimental group

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.

Treatment:

Procedure: Laparoscopic ovarian cyst surgery

Ovarian Cyst Enucleation

Experimental group

Description:

The ovarian cyst is enucleated by complete removal of the cyst lining with preservation of surrounding ovarian tissue.

Treatment:

Procedure: Laparoscopic ovarian cyst surgery