ClinicalTrials.gg
RecruitingNCT06852313Updated Apr 28, 2026

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

An interventional study of Laparoscopic ovarian cyst surgery in Ovarian Cyst Benign, sponsored by University Children's Hospital, Zurich. Recruiting at 2 sites in Switzerland. Open to female participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-04-28.

Sponsored by University Children's Hospital, Zurich · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
1 Year to 18 Years
Sex
Female
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Study summary

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.

02

Conditions studied

  • Ovarian Cyst Benign

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Keywords

  • Ovarian cyst
  • Laparoscopy
  • Child
03

In context

Ovarian Cysts

80 studies on the registry are indexed under Ovarian Cysts; 16 are open to participants now.

This study's planned enrollment of 80 is close to the median of 74 across 51 interventional studies indexed under Ovarian Cysts.

Browse Ovarian Cysts studies →

Lead sponsor

University Children's Hospital, Zurich is the lead sponsor of 95 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Neonatal ovarian cysts (age \<12 months)
  • Age >18 years
  • Complex cysts (with solid components, e.g., Teratoma, risk or suspicion of )
  • Paratubar/paraovarian cysts
  • Medical reason that precludes cyst enucleation (e.g. severe coagulopathy)
  • Neither signed form or inadequate german, french or english language skills to give informed consent
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    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.

    Procedure: Laparoscopic ovarian cyst surgery

  • Experimental
    Ovarian Cyst Enucleation

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

    Procedure: Laparoscopic ovarian cyst surgery

Interventions

  • ProcedureLaparoscopic 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.

06

What researchers measure

Primary outcomes

  1. Postoperative change of AMH level

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

    Time frame: 8 weeks

Secondary outcomes

  1. Postoperative recurrence rate

    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"

    Time frame: 14 weeks

Other outcomes

  1. Intraoperative complications

    The investigators will describe any intraoperative complications.

    Time frame: 2 weeks

  2. Operative times

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

    Time frame: 2 weeks

  3. Postoperative ipsilateral ovarian volume on ultrasound

    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.

    Time frame: 14 weeks

  4. Postoperative adnexal ratio

    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.

    Time frame: 14 weeks

  5. Postoperative histology

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

    Time frame: 8 weeks

  6. Postoperative microscopic follicle count

    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.

    Time frame: 14 weeks

  7. Postoperative complications

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

    Time frame: 14 weeks

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2026 (actual). Primary completion is estimated for Apr 2028, 25 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 19, 2025
First posted
Feb 28, 2025
StartActual
Feb 5, 2026
Primary completionEst.
Apr 1, 2028
CompletionEst.
Dec 1, 2028
Last update
Apr 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06852313
Lead sponsor
University Children's Hospital, Zurich
Collaborators
University Children's Hospital Basel
Responsible party
Uchenna Kennedy (Principal Investigator, University Children's Hospital, Zurich) — Principal investigator
First posted
Feb 28, 2025
Start date
Feb 5, 2026
Primary completion
Apr 1, 2028 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Apr 28, 2026

Study contacts

Uchenna Kennedy, MD
Contact
uchenna.kennedy@kispi.uzh.ch
0041 2494949
Ueli Möhrlen, Prof. Dr. med.
Contact
ueli.möhrlen@kispi.uzh.ch
00412494949

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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