Save the Ovaries - Surgical Management of Simple Ovarian Cysts in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Postoperative change of AMH level
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Ovarian Cyst Deroofing
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.
干预措施: Laparoscopic ovarian cyst surgery (Procedure)
Ovarian Cyst Enucleation
The ovarian cyst is enucleated by complete removal of the cyst lining with preservation of surrounding ovarian tissue.
干预措施: Laparoscopic ovarian cyst surgery (Procedure)
结局指标
主要结局
Postoperative change of AMH level
时间窗: 8 weeks
Change in AMH level postoperatively compared to preoperative AMH levels (measured in pmol/L).
次要结局
- Postoperative recurrence rate(14 weeks)
研究者
Uchenna Kennedy
Principal Investigator
University Children's Hospital, Zurich