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

University Children's Hospital, Zurich80 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Ovarian Cyst Benign

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.

Eligibility

Sex: FEMALEMin age: 1 YearMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

University Children's Hospital Basel

Basel, Switzerland

RECRUITING

University Children's Hospital Zurich

Zurich, Switzerland

RECRUITING

Outcomes

Primary Outcomes

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

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

Central Contacts

Uchenna Kennedy, MD

CONTACT

0041 2494949 uchenna.kennedy@kispi.uzh.ch

Ueli Möhrlen, Prof. Dr. med.

CONTACT

00412494949 ueli.möhrlen@kispi.uzh.ch

Data from ClinicalTrials.gov

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