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| Name | Class |
|---|---|
| University Children's Hospital Basel | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ovarian Cyst Deroofing | Experimental | 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. |
|
| Ovarian Cyst Enucleation | Experimental | The ovarian cyst is enucleated by complete removal of the cyst lining with preservation of surrounding ovarian tissue. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic ovarian cyst surgery | Procedure | 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. |
| 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 |
| 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" |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Uchenna Kennedy, MD | Contact | 0041 2494949 | uchenna.kennedy@kispi.uzh.ch | |
| Ueli Möhrlen, Prof. Dr. med. | Contact | 00412494949 | ueli.möhrlen@kispi.uzh.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Children's Hospital Basel | Recruiting | Basel | Switzerland |
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| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
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| 14 weeks |
| 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 |
| University Children's Hospital Zurich | Recruiting | Zurich | Switzerland |
|
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |