Study for the Evaluation of the Efficiency of a Device for the Diagnosis of an Internal Rectal Prolapse, a Pelvic Floor Ptosis and for the Determination of an Internal Hernia Into the Douglas Pouch
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Determination if the device will be effective for the diagnosis of an internal rectal prolapse, a pelvic floor ptosis and for the determination of an internal hernia into the Douglas pouch.
研究概览
简要总结
The purpose of this study is to determine if the device is supplying sufficient diagnosis results of an internal rectal prolapse, of a pelvic floor ptosis and for the determination of an interal hernia into the Douglas pouch, as well as to determine the technical success of using the device at the patient.
详细描述
Existing diagnosis methods are inadequate, inaccurate, complicated or can only made intraoperatively. The new device should enable a fast and easy examination procedure well tolerated by the patients. The diagnosis results, received with the device, should assist in the accurate selection of patients for operations as well as to avoid any unnecessary operations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •female patients
- •patients with ODS-Symptome-Score according Longo of >7
- •existing results about a perceptible and seeable internal rectal prolapse, pelvic floor ptosis and an internal hernia into the Douglas pouch
- •patients who correspond to to the ASA 1 - ASA 2 criteria
排除标准
- •male patients
- •female patients with inflammable or malign diseases of the urogenital tract as well as of the anorectal area and after rectum operation
- •female patients with diarrhea
- •pregnant patients because of the x-ray examination
- •female patients who get anticoagulants
- •serious cardiopulmonary disorders
- •disorders of the blood coagulation
- •female patients who correspond to the ASA 3 to ASA 4 criteria
结局指标
主要结局
Determination if the device will be effective for the diagnosis of an internal rectal prolapse, a pelvic floor ptosis and for the determination of an internal hernia into the Douglas pouch.
时间窗: 4 months
次要结局
- Determination if the the use of the device will be tolerated by the patient combined with a low level of pain or discomfort.(4 months)