Role of Sclerotherapy in Treatment of Non-neoplastic Ovarian Cyst
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- role of sclerotherapy in treatment of non-neoplastic ovarian cysts
研究概览
简要总结
The aim of this study was to evaluate the role of sclerotherapy (injection of tetracycline or injection of Polidocanol - 95% hydroxypolyethoxydodecane and 5% ethanol -) in treatment of non-neoplastic ovarian cysts by, percutaneous trans-abdominal approach or trans-vaginal approach.
详细描述
Ovarian cysts are fluid-filled sacs that form in or on an ovary. Such cysts are relatively common. Most are non-cancerous (benign) and disappear on their own. Ovarian cancer is more likely to occur in women over 50.
Most of the patients with ovarian cyst are symptomless and resolves spontaneously. If untreated, complications such as rupture, torsion, malignant transformation may occur.
Cyst rupture can lead to peritoneal signs, abdominal distension and bleeding, irregularity of the menstrual cycle and abnormal vaginal bleeding, dull bilateral pelvic pain may result from the lutein cysts.
Until recent times, surgery in the form of laparotomy or laparoscopy has been the first choice. However, ultrasonography guided aspiration of the cysts as an alternative treatment is the fast catching up and may even be procedure of choice in the management of ovarian cysts in a selected group of women as it has low recurrence rate, low risk, less cost and in most cases no hospital stay.
There are various types of ovarian cysts, such as functional cysts, follicular cysts, corpus luteum cysts, hemorrhagic cysts, theca-lutein cysts, peritoneal inclusion cysts or pseudo-cysts, polycystic ovaries and endometriomas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 48 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients were diagnosed with non-neoplastic ovarian cysts (i.e., simple, hemorrhagic, complicated, endometriotic cysts).
- •All Patients from 15 to 48 years old.
- •Size from (5 to 10 cm).
- •Cyst wall thickness < 5 mm.
- •Negative tumor markers (Cancr Antigen125, Cancer Embryonic Antigen, Cancer Antigen19.9 & alpha fetoprotein).
- •Persisted for more than 3 months.
- •Normal color Doppler blood flow analysis.
- •Resistant to hormonal treatment COCs.
- •Patients accepted to be enrolled in the study.
排除标准
- •Family history of ovarian cancer.
- •USG features suggesting malignancy like: multilocular, papillary projections or mural nodule, cyst wall thickness >5mm, low Doppler indices (PI≤1 and or RI≤0.40, centrally located vessels, randomly dispersed vessels).
- •Known allergy to sclerosing agent (tetracycline or Polidocanol).
- •Bleeding tendency as (patients with platelet count <50,000, patients with Uncorrected Coagulopathy with International Normalized Ratio >1.5, or patients on antithrombotic therapy without stoppage of doses till 5 days before the procedure.
结局指标
主要结局
role of sclerotherapy in treatment of non-neoplastic ovarian cysts
时间窗: followed up from 1 month to 6 months
The main outcome measure was the disappearance of the cyst and the avoidance of surgery. The cyst was considered resolved if follow-up revealed either no cystic lesion or only a follicle-like cyst no more than 30 mm in diameter.
次要结局
未报告次要终点
研究者
Asmaa Ahmed Syed Ahmed
Resident Doctor
Al-Azhar University