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.

Study Overview

• Status: Recruiting
• Conditions: Ovarian Cyst Benign
• Intervention / Treatment: Procedure: Laparoscopic ovarian cyst surgery

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Uchenna Kennedy, MD; Phone Number: 0041 2494949; Email: uchenna.kennedy@kispi.uzh.ch
• Study Contact Backup: Name: Ueli Möhrlen, Prof. Dr. med.; Phone Number: 00412494949; Email: ueli.möhrlen@kispi.uzh.ch

Study Locations

• Switzerland
  • Basel, Switzerland
    • Recruiting
    • University Children's Hospital Basel
    • Contact: Ulrike Subotic, MD; Phone Number: +41617041212; Email: ulrike.subotic@ukbb.ch
    • Principal Investigator: Ulrike Subotic, MD
  • Zurich, Switzerland
    • Recruiting
    • University Children's Hospital Zurich
    • Contact: Uchenna Kennedy, MD; Phone Number: +412494949; Email: uchenna.kennedy@kispi.uzh.ch
    • Principal Investigator: Uchenna Kennedy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative change of AMH level	Change in AMH level postoperatively compared to preoperative AMH levels (measured in pmol/L).	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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"	14 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative complications	The investigators will describe any intraoperative complications.	2 weeks
Operative times	The investigators will measure the operative times in minutes for both techniques.	2 weeks
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.	14 weeks
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.	14 weeks
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.	8 weeks
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.	14 weeks
Postoperative complications	Postoperative complications will be described by the Clavien-Madadi Classification.	14 weeks

Collaborators and Investigators

• Sponsor: University Children's Hospital, Zurich
• Collaborators: University Children's Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 25, 2025
• First Posted (Actual): February 28, 2025

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Child; Laparoscopy; Ovarian cyst
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Cysts; Ovarian Cysts
• Other Study ID Numbers: SAVEOVPRO2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No