Save the Ovaries! Surgical Treatment of Ovarian Cysts in Girls and Adolescents
Zusammenfassung der Studie
The purpose of this study is to evaluate which surgical technique should be used to treat simple ovarian cysts in girls and adolescents. The two techniques being compared are laparoscopic cystectomy and laparoscopic cyst decapsulation. Participants in this study will be randomly assigned to one of the two surgical methods. The researchers will assess the effects of both techniques on ovarian reserve and the risk of recurrence of cysts.
(BASEC)
Untersuchte Intervention
This study investigates the surgical treatment of ovarian cysts. The two techniques being compared are laparoscopic cystectomy and laparoscopic cyst decapsulation.
(BASEC)
Untersuchte Krankheit(en)
Ovarian Cysts
(BASEC)
Girls and adolescents aged 1-18 years with simple ovarian cysts requiring surgical treatment will be included. (BASEC)
Ausschlusskriterien
Newborns and infants under 1 year, adolescents over 18 years, and patients with complex ovarian cysts will be excluded. (BASEC)
Studienstandort
Basel, Zürich
(BASEC)
Sponsor
Prof. Dr. med. Ueli Möhrlen
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Dr. med. Uchenna Kennedy
+41 442497379
uchenna.kennedy@clutterkispi.uzh.chUniversity Children's Hospital Zurich Lenggstrasse 30 8008 Zurich
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
22.07.2025
(BASEC)
ICTRP Studien-ID
NCT06852313 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Save the Ovaries! Surgical management of simple ovarian cysts in children and adolescents (BASEC)
Wissenschaftlicher Titel
Save the Ovaries - Surgical Management of Simple Ovarian Cysts in Children and Adolescents (ICTRP)
Öffentlicher Titel
Save the Ovaries - Surgical Management of Simple Ovarian Cysts in Children and Adolescents (ICTRP)
Untersuchte Krankheit(en)
Ovarian Cyst Benign (ICTRP)
Untersuchte Intervention
Procedure: Laparoscopic ovarian cyst surgery (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant). (ICTRP)
Ein-/Ausschlusskriterien
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 (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Postoperative change of AMH level (ICTRP)
Postoperative recurrence rate (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
University Children's Hospital Basel (ICTRP)
Weitere Kontakte
Uchenna Kennedy, MD, uchenna.kennedy@kispi.uzh.ch, 0041 2494949 (ICTRP)
Sekundäre IDs
SAVEOVPRO2025 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06852313 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar