Small Intestinal Submucosa Graft as an Alternative to Conventional Buccal Mucosa for Substitution Urethroplasty of Anterior Urethral Strictures
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Urethral patency
研究概览
简要总结
The field of research for this study is tissue engineering and the utilization of a small intestinal submucosa graft as a substitute biomaterial for conventional buccal mucosa in substitution urethroplasty of anterior urethral strictures.
详细描述
Urethral stricture refers to the abnormal narrowing of the urethral lumen resulting from fibrosis that affects the urethral epithelium and underlying corpus spongiosum. The management of urethral stricture longer than 2 cm a major therapeutic challenge in clinics. Currently available surgical techniques require harvesting of grafts from autologous sites. However, there are numerous disadvantages associated with autografts, such as limited availability and variable quality, donor site morbidity, increased risk of surgical complications; thereby the application of this method is especially limited for large defects.
The hypothesis of this study is that the small intestinal submucosa graft can be used as an alternative biomaterial to buccal mucosa for substitution urethroplasty in urethral stricture patients. The aim of this study is to assess safety and efficacy of surgical treatment of patients with anterior urethral stricture using a small intestinal submucosa graft. The follow-up time for all patients in this study was 5 years. The follow-up regimen includes retrograde and pericatheter urethrography, voiding cystourethrography, uroflowmetry, cystoscopy, and voiding symptoms monitoring. Telephone follow-up will take place in between these assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients signed informed consent form
- •Patients with a single, longer than 2.0 cm and shorter than or equal to 7.0 cm anterior urethral stricture
- •Patients undergoing substitution urethroplasty for urethral stricture.
排除标准
- •Patients without surgical indication
- •Subtotal and total urethral strictures
- •Radiation therapy to the abdomen or pelvis
- •Lichen sclerosis related strictures
- •Patients with previous hypospadias repair
- •Neurogenic urinary tract disorders
- •Mental disorders
- •Patients with a known biologic sensitivity or a cultural aversion to the use of porcine materials.
- •Patients with severe dysfunction of heart, lung, liver, kidney and other important organs , endocrine system and blood system.
- •Patient with malignant tumor
- •Patient who cannot be regularly examined due to any circumstances
- •Any clinical state which does not ensure the safe implementation of study procedure (investigator's view)
结局指标
主要结局
Urethral patency
时间窗: 4 weeks post-surgery
A peri-urethrogram will be performed prior to catheter removal
次要结局
- Serious adverse events(4 weeks post-surgery)
- Voiding symptoms(2 months up-to 5 years post-surgery)
- Urine flow(2 months up-to 5 years post-surgery)
- Anatomic recurrence of urethral stricture observed by cystoscopy 、 Retrograde urethrography(RUG)、 Voiding cystourethrography(VCUG)(Through study completion, an average of up to 5 years)
研究者
Xiaoyong Zeng
Professor
Tongji Hospital