Assessing outcomes following penile corrective surgeries using bovine pericardial patch: A prospective cohort study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- • Safety: Incidence of adverse events related to the use of bovine pericardial patch, including
研究概览
简要总结
The study will be single centric, prospective, interventional clinical study. Patients with Peyronie’s disease, requiring penile corrective surgery using bovine pericardium graft; willing to participate and provide informed consent will be recruited for the study after meeting the inclusion criteria. Intervention planned: Plaque incision and grafting of the defect with bovine pericardium for patients with Peyronie’s disease.
Comparison: Pre and post-operative Penile Curvature, erectile dysfunction will be assessed clinically. Data Collection: Data will be collected through medical records, intraoperative observations, postoperative follow-up visits, and clinical photos of erection. Patient demographics, preoperative conditions, and intraoperative details will be documented. Adverse events and complications will be systematically recorded and graded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Male
入选标准
- •Patients with disabling penile curvature
- •Tunical plaques in patients with Peyronie’s disease
- •Willingness to participate and provide informed consent.
排除标准
- •Patients requiring prostheses
- •Congenital penile curvature
- •Patients with constriction bands, unilateral indentations, and hourglass deformities
- •Patients with known allergies to bovine products or pre-existing conditions contraindicating the use of bovine pericardial patches.
结局指标
主要结局
• Safety: Incidence of adverse events related to the use of bovine pericardial patch, including
时间窗: The study will follow up with patients for a minimum of 1 month postoperatively to evaluate short-term | outcomes. Long-term outcomes will also be assessed during subsequent follow-up periods, 3 months, 6 | months and 1 year.
infections, thrombosis, and allergic reactions.
时间窗: The study will follow up with patients for a minimum of 1 month postoperatively to evaluate short-term | outcomes. Long-term outcomes will also be assessed during subsequent follow-up periods, 3 months, 6 | months and 1 year.
• Efficacy: Patency rates of the grafts assessed through clinical photos of erection at specified
时间窗: The study will follow up with patients for a minimum of 1 month postoperatively to evaluate short-term | outcomes. Long-term outcomes will also be assessed during subsequent follow-up periods, 3 months, 6 | months and 1 year.
follow-up intervals.
时间窗: The study will follow up with patients for a minimum of 1 month postoperatively to evaluate short-term | outcomes. Long-term outcomes will also be assessed during subsequent follow-up periods, 3 months, 6 | months and 1 year.
次要结局
- • Patients will be examined post-surgery by evaluating the ability to perform successful sexual(intercourse, improvements in curvature, and satisfaction with treatment)
研究者
Dr Pankaj Joshi
Urokul Hospital