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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Laparoscopic ovarian cyst surgery
Procedure/SurgeryLaparoscopic 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.
Treatment groups
Trial outcomes
Primary outcomes
Postoperative change of AMH level
Change in AMH level postoperatively compared to preoperative AMH levels (measured in pmol/L).
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"
Other outcomes
Intraoperative complications
The investigators will describe any intraoperative complications.
Operative times
The investigators will measure the operative times in minutes for both techniques.
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.
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.
Sponsors and contacts
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University Children's Hospital, Zurich
Lead sponsor
University Children's Hospital Basel
Collaborator