RECRUITINGINTERVENTIONAL
Save the Ovaries - Surgical Management of Simple Ovarian Cysts in Children and Adolescents
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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)
Who Should NOT Join This Trial:
- 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 willing to sign a consent form form or inadequate german, french or english language skills to give willing to sign a consent form
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
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.
Locations (2)
University Children's Hospital Basel
Basel, Switzerland
University Children's Hospital Zurich
Zurich, Switzerland