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临床试验/NCT05376384
NCT05376384已完成不适用

Ovarian Cyst's Enucleation Spillage Score. An Observational Study of Cyst Characteristics for Spillage During Laparoscopic Enucleation

University of Campania "Luigi Vanvitelli"1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2022年5月12日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlo Ronsini

Principal Investigator

University of Campania "Luigi Vanvitelli"

研究点 (1)

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