Lord´s Procedure Versus Sclerotherapy for Testicular Hydrocele; a Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- Cure from symptomatic hydrocele within 6 months of randomization
研究概览
简要总结
This study will compare a minimal invasive operation in local anesthesia with sclerotherapy for symptomatic testicular hydrocele within 6 months after randomization. Thirty days complication rates will be assessed. The hypothesis is that surgery will lead to faster cure while sclerotherapy would be cheaper and have less complications.
详细描述
Testicular hydrocele is a common disorder even though it´s exact prevalence is unknown. In areas with filariasis it´s endemic.
Hydrocele is a benign condition where fluid accumulates in between two layers of tunica vaginalis (embryologically, the peritoneum), surrounding the testicle. The cause is unknown but inflammatory conditions is believed to induce these changes. The pathogenesis of hydrocele is believed to be a nonbalanced secretion and resorption of fluid.
Diagnosis of hydrocele is easy since the patient presents with an enlarged scrotum and clinical investigation including palpation and transillumination of the scrotum confirms the diagnosis. A scrotal ultrasound might be indicated to rule out a malignancy or if the diagnosis is unclear.
Treatment for hydrocele is only indicated when the patient has symptoms since all treatment modalities carries risk of complications, such as hematoma, infection, pain and even infertility concerns has been raised.
Operative management is considered the golden standard of treatment when considering recurrence but less invasive procedures such as sclerotherapy is frequently used, mainly due to cost and complications issues.
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Symptomatic testicular hydrocele, with more than 2 points on a validated inguinal botherscore (Inguinal Pain Questionnaire, IPQ)
- •More than 40ml of hydrocele fluid
- •Age>40 years
- •Completed reproduction
- •Oral and written consent to participate in the study
- •American Association of Anesthesiology (ASA) grade≤ 3
排除标准
- •Other ipsilateral scrotal disease (tumour, ongoing inflammatory disease of the scrotum,)
- •Ongoing urinary infection
- •Ipsilateral inguinal hernia
- •Paternity wish
- •Not possible to drain the hydrocele fully
- •Opaque fluid drained on emptying the hydrocele
- •Bilateral hydrocele where both sides has symptom score more than 2p on IPQ.
结局指标
主要结局
Cure from symptomatic hydrocele within 6 months of randomization
时间窗: Every 3 months until 6months from randomization
次要结局
- Postoperative complications(Within 30 days from treatment)
研究者
Karl-Johan Lundström
MD, resident Urologist
Umeå University