Save the Ovaries! Surgical Treatment of Ovarian Cysts in Girls and Adolescents
Résumé de l'étude
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)
Intervention étudiée
This study investigates the surgical treatment of ovarian cysts. The two techniques being compared are laparoscopic cystectomy and laparoscopic cyst decapsulation.
(BASEC)
Maladie en cours d'investigation
Ovarian Cysts
(BASEC)
Girls and adolescents aged 1-18 years with simple ovarian cysts requiring surgical treatment will be included. (BASEC)
Critères d'exclusion
Newborns and infants under 1 year, adolescents over 18 years, and patients with complex ovarian cysts will be excluded. (BASEC)
Lieu de l’étude
Bâle, Zurich
(BASEC)
Sponsor
Prof. Dr. med. Ueli Möhrlen
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dr. med. Uchenna Kennedy
+41 442497379
uchenna.kennedy@clutterkispi.uzh.chUniversity Children's Hospital Zurich Lenggstrasse 30 8008 Zurich
(BASEC)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
22.07.2025
(BASEC)
Identifiant de l'essai ICTRP
NCT06852313 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Save the Ovaries! Surgical management of simple ovarian cysts in children and adolescents (BASEC)
Titre académique
Save the Ovaries - Surgical Management of Simple Ovarian Cysts in Children and Adolescents (ICTRP)
Titre public
Save the Ovaries - Surgical Management of Simple Ovarian Cysts in Children and Adolescents (ICTRP)
Maladie en cours d'investigation
Ovarian Cyst Benign (ICTRP)
Intervention étudiée
Procedure: Laparoscopic ovarian cyst surgery (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
Postoperative change of AMH level (ICTRP)
Postoperative recurrence rate (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
University Children's Hospital Basel (ICTRP)
Contacts supplémentaires
Uchenna Kennedy, MD, uchenna.kennedy@kispi.uzh.ch, 0041 2494949 (ICTRP)
ID secondaires
SAVEOVPRO2025 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06852313 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible