Ovarian Cyst Benign
Conditions
Keywords
Ovarian cyst, Laparoscopy, Child
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.
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.
Sponsors
University Children's Hospital, Zurich
University Children's Hospital Basel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
1 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative change of AMH level | 8 weeks | Change in AMH level postoperatively compared to preoperative AMH levels (measured in pmol/L). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative recurrence rate | 14 weeks | 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" |
Countries
Switzerland
Contacts
CONTACTUchenna Kennedy, MD
CONTACTUeli Möhrlen, Prof. Dr. med.
Outcome results
None listed