Risks and Benefits of Using External Scrotal Drainage in Three-piece Penile Prosthesis Implant: a Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Post-operative infectious episodes
研究概览
简要总结
The goal of this prospective randomized study is to demonstrate if the use of an external scrotal drainage in penile prosthetic surgery can reduce the risk of post-operative complications without increase the risk of infections.
详细描述
After being informed about the study, all patients give writted informed consent. After that they will be randomized in two groups (A with drainage, B without drainage) using a random sequence generator. Then the patient will undergo the implantation of a three-component penile prosthesis following peri antibiotic prophylaxis with cephalosporins and aminoglycosides, the antibiotic prophylaxis will be continued on the first post-operative day surgery with a cephalosporin. In the group A it will be positioned at the scrotal level (using surgical access or using a second incision) an external drainage (10 Ch in aspiration) for 24 hours. The drainage will be removed on the first post-operative day. The degree of the hematoma will be determined using a 5-point Likert scales already approved in previous cases. Subsequently patients will carry out periodic check-ups at 7, 15 and 30 days after the operation to evaluate the appearance of hematomas and surgical site infection. After that, they will carry out check-ups every month for the first 3 months, then every 3 months for the first year and finally annually up to the fifth year after the intervention. During the clinical check-ups, it will also be defined the time of use of the penile prosthesis.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Written informed consent signed voluntarily according to the rules of good clinical practice (Declaration of Helsinki) and national regulations (Appendix B).
- •Genetically male patient.
- •Age ≥ 18 years.
- •Patient suffering from ED of variable and/or multifactorial etiology.
- •Patient suffering from ED not responsive to iPDE-
- •Patient suffering from unresponsive or non-tolerant ED
排除标准
- •Absence of signed written informed consent (Appendix B).
- •Age <18 years.
- •Genetically female patients.
- •Patient with active peno-scrotal infection.
- •Patient with active systemic infection.
- •Immunosuppressed patient.
- •Patient with haematological pathologies that may cause an increased risk of bleeding.
- •Patients suffering from Peyronie's Disease who must undergo simultaneous plaque surgery.
- •Any condition or situation that, in the opinion of the investigator, places the patient at significant risk, may confound the results of the study, or significantly interfere with the patient's participation in the study.
- •The patient declares that it will be impossible for him to participate in follow-up consultations.
研究组 & 干预措施
Group without drainage
Group with drainage
干预措施: External scrotal drainage (Device)
结局指标
主要结局
Post-operative infectious episodes
时间窗: One month
Define the number of post-operative infectious episodes in the two study arms.
次要结局
- Effectiveness of external drainage in subgroups(Up to 12 months)
- Manipulation of the activation pump(Up to 12 weeks)
- Post-surgical hematoma(One month)
- Volume of drained material(24 hour)
- Use of the penile prosthesis(Up to 12 weeks)
- Activation of the device(Up to 12 weeks)
研究者
Mirko Preto
Principal Investigator
A.O.U. Città della Salute e della Scienza