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

NCT ID: NCT06852313

Last Updated: 2026-01-09

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-14

Study Completion Date

2028-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Cyst Benign

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Group Type EXPERIMENTAL

Laparoscopic ovarian cyst surgery

Intervention Type PROCEDURE

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.

Group Type EXPERIMENTAL

Laparoscopic ovarian cyst surgery

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Children's Hospital Basel

OTHER

Sponsor Role collaborator

University Children's Hospital, Zurich

OTHER

Sponsor Role lead

Responsible Party

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Uchenna Kennedy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Children's Hospital Basel

Basel, , Switzerland

Site Status RECRUITING

University Children's Hospital Zurich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Uchenna Kennedy, MD

Role: CONTACT

0041 2494949

Ueli Möhrlen, Prof. Dr. med.

Role: CONTACT

Facility Contacts

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Ulrike Subotic, MD

Role: primary

+41617041212

Uchenna Kennedy, MD

Role: primary

+412494949

Other Identifiers

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SAVEOVPRO2025

Identifier Type: -

Identifier Source: org_study_id

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