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NCT Number: NCT06852313

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

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.

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Key information

Conditions

Ovarian Cyst Benign Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

1 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Children's Hospital Basel, Basel, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic ovarian cyst surgery

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.

Primary outcomes

  1. Postoperative change of AMH level

    Time frame: 8 weeks

    Change in AMH level postoperatively compared to preoperative AMH levels (measured in pmol/L).

Secondary outcomes

  1. Postoperative recurrence rate

    Time frame: 14 weeks

    Postoperative recurrence is defined as an ipsilateral asymptomatic cyst ≥ 4cm or a cyst of any size that requires a medical or surgical intervention due to symptoms at follow-up 6-8 weeks postoperatively.

    If the asymptomatic cyst is < 4cm, a second follow-up will be performed at 10-14 weeks postoperatively. Recurrence is then defined as ipsilateral asymptomatic cyst ≥ 4cm or a cyst of any size that requires a medical or surgical intervention due to symptoms.

    The outcome will be measured as "recurrence/no recurrence"

Other outcomes

  1. Intraoperative complications

    Time frame: 2 weeks

    The investigators will describe any intraoperative complications.

  2. Operative times

    Time frame: 2 weeks

    The investigators will measure the operative times in minutes for both techniques.

  3. Postoperative ipsilateral ovarian volume on ultrasound

    Time frame: 14 weeks

    The postoperative ipsilateral ovarian volume will be calculated by ultrasound (Ovarian Volume: V (in ml) = long axis in cm x transversal axis x ap diameter x 0.5) and compared to published standard ovarian volumes in ml according to age.

  4. Postoperative adnexal ratio

    Time frame: 14 weeks

    The adnexal ratio will be calculated by division of the volume of the affected ovary (in ml) with the volume of the unaffected ovary (in ml). If the adnexal ratio is <1 postoperatively, this can be a sign of postoperative volume loss.

  5. Postoperative histology

    Time frame: 8 weeks

    The investigators will assess the histology of the cyst wall according to the following entities: functional cyst/ serous cystadenoma/ mucinous cystadenoma/ other entity.

  6. Postoperative microscopic follicle count

    Time frame: 14 weeks

    The investigators will count the number of follicles that were removed on a representative sample of the surgical specimen, which will contain cyst wall +/- ovarian cortex.

  7. Postoperative complications

    Time frame: 14 weeks

    Postoperative complications will be described by the Clavien-Madadi Classification.

Study contacts

Contact information is provided by the study sponsor or research team.

Uchenna Kennedy, MD

CONTACT

[email protected]

0041 2494949

Ueli Möhrlen, Prof. Dr. med.

CONTACT

ueli.mö[email protected]

00412494949

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Collaborators

  • University Children's Hospital Basel

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 28, 2025
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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