NCT06852313

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
31mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Feb 2026Dec 2028

First Submitted

Initial submission to the registry

February 19, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
11 months until next milestone

Study Start

First participant enrolled

February 5, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 28, 2026

Status Verified

May 1, 2025

Enrollment Period

2.2 years

First QC Date

February 19, 2025

Last Update Submit

April 27, 2026

Conditions

Ovarian Cyst Benign

Keywords

Ovarian cystLaparoscopyChild

Outcome Measures

Primary Outcomes (1)

  • Postoperative change of AMH level

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

    8 weeks

Secondary Outcomes (1)

  • Postoperative recurrence rate

    14 weeks

Other Outcomes (7)

  • Intraoperative complications

    2 weeks

  • Operative times

    2 weeks

  • Postoperative ipsilateral ovarian volume on ultrasound

    14 weeks

  • +4 more other outcomes

Study Arms (2)

Ovarian Cyst Deroofing

EXPERIMENTAL

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

Ovarian Cyst Enucleation

EXPERIMENTAL

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

Procedure: Laparoscopic ovarian cyst surgery

Interventions

Laparoscopic ovarian cyst surgeryPROCEDURE

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 DeroofingOvarian Cyst Enucleation

Eligibility Criteria

Age1 Year - 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Children's Hospital Basel

Basel, Switzerland

RECRUITING

University Children's Hospital Zurich

Zurich, Switzerland

RECRUITING

MeSH Terms

Conditions

Ovarian Cysts

Condition Hierarchy (Ancestors)

CystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Central Study Contacts

Uchenna Kennedy, MD

CONTACT

0041 2494949uchenna.kennedy@kispi.uzh.ch

Ueli Möhrlen, Prof. Dr. med.

CONTACT

00412494949ueli.möhrlen@kispi.uzh.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2025

First Posted

February 28, 2025

Study Start

February 5, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

April 28, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CH(2)