Ovarian Cyst's Enucleation Spillage Score. An Observational Study of Cyst Characteristics for Spillage During Laparoscopic Enucleation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Spillage Rate
研究概览
简要总结
Cystic enucleation is one of the most common conservative surgeries in gynecology; it is commonly performed by a minimally invasive approach such as laparoscopy. A high percentage of these surgeries (6-88 % of cases) are complicated by the cystic rupture with intra-abdominal spillage of its contents (spillage). This occurrence affects the surgical and prognostic outcome by lengthening the time of surgery, increasing the risk of postoperative infection or granulomatous peritonitis, of possible second manifestation of the pathology (example: endometriosis), and in the case of neoformation of a carcinomatous nature by leading to an increase in the stage of disease, exposing patients to a prognostic disadvantage and the need for adjuvant treatments also avoidable. In addition, the previous spillage may be associated with the adherent syndrome with repercussions on patients' morbidity and fertility. For these reasons, it is crucial to optimize the selection of patients who are candidates for cystic enucleation.
The present study aims to evaluate a series of ultrasound, medical history, and surgical-preoperative parameters to develop a predictive score for the risk of spillage during laparoscopic surgery. Prospective Observational Study. The study aims to enroll 156 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients >18 years of age
- •Patients undergoing laparoscopic cystic enucleation
- •Patients who underwent pelvic ultrasound examination within 30 days prior to surgery
- •Patients who signed informed consent for the study
- •ECOG performance status < 2
排除标准
- •Pregnancy status
- •Patients with cardiological, neurological, or metabolic disorders not treated pharmacologically
- •Patients undergoing laparotomy conversion prior to enucleation
结局指标
主要结局
Spillage Rate
时间窗: 12 months
Identification of spillage rate during laparoscopic cystic enucleation in patients with the risk factors considered.
次要结局
未报告次要终点
研究者
Carlo Ronsini
Principal Investigator
University of Campania "Luigi Vanvitelli"
