Save the Ovaries! Surgical Treatment of Ovarian Cysts in Girls and Adolescents
Descrizione riassuntiva dello studio
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)
Intervento studiato
This study investigates the surgical treatment of ovarian cysts. The two techniques being compared are laparoscopic cystectomy and laparoscopic cyst decapsulation.
(BASEC)
Malattie studiate
Ovarian Cysts
(BASEC)
Girls and adolescents aged 1-18 years with simple ovarian cysts requiring surgical treatment will be included. (BASEC)
Criteri di esclusione
Newborns and infants under 1 year, adolescents over 18 years, and patients with complex ovarian cysts will be excluded. (BASEC)
Luogo dello studio
Basilea, Zurigo
(BASEC)
Sponsor
Prof. Dr. med. Ueli Möhrlen
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dr. med. Uchenna Kennedy
+41 442497379
uchenna.kennedy@clutterkispi.uzh.chUniversity Children's Hospital Zurich Lenggstrasse 30 8008 Zurich
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
22.07.2025
(BASEC)
ID di studio ICTRP
NCT06852313 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Save the Ovaries! Surgical management of simple ovarian cysts in children and adolescents (BASEC)
Titolo accademico
Save the Ovaries - Surgical Management of Simple Ovarian Cysts in Children and Adolescents (ICTRP)
Titolo pubblico
Save the Ovaries - Surgical Management of Simple Ovarian Cysts in Children and Adolescents (ICTRP)
Malattie studiate
Ovarian Cyst Benign (ICTRP)
Intervento studiato
Procedure: Laparoscopic ovarian cyst surgery (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
Postoperative change of AMH level (ICTRP)
Postoperative recurrence rate (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
University Children's Hospital Basel (ICTRP)
Contatti aggiuntivi
Uchenna Kennedy, MD, uchenna.kennedy@kispi.uzh.ch, 0041 2494949 (ICTRP)
ID secondari
SAVEOVPRO2025 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06852313 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile