Urethral Stricture Repair: A Prospective Randomized Analysis Between Jugal or Labial Graft in Buccal Mucosa Urethroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 主要终点
- Labial Group Success Rate
研究概览
简要总结
Buccal mucosa urethroplasty is a current fashion in urethral stricture management. In our university centre (Hospital de Clínicas de Porto Alegre) is a common surgical treatment choice. This paper aims to evaluate the success rate of this treatment after randomized choice between labial and jugal (inner cheek) grafts during the past two years.
详细描述
Free dorsal graft urethroplasty, first described by Barbagli et al, has been shown better results than ventral grafts. Fixed grafts on the corpora cavernosa results in a better mechanical support and vascular supply, with less chance to complications such as pseudodiverticula and sacculations either a better urethral phisiology.
This study aims to evaluate the current surgical management in our centre: buccal mucosa graft urethroplasty with jugal or labial replacement, comparing their group success rate and complications between the groups in patients led to surgery from October 2016 to June 2018.
Prospective analysis from urethral stricture surgical HCPA patient data by dorsal buccal mucosa graft urethroplasty. The graft choice were done by a software. Longer stricture with transoperative need for the two grafts use were excluded. Success rate were measured with a no stricture de novo or absence of complications in a six month interval.
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
- Single (Participant)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Urethral Stricture Diagnosis
- •Indication for buccal mucosa graft urethroplasty
- •Accept the Informed Consent Term (patient or responsible)
排除标准
- •Severe urethral stricture which a two-staged procedure are required
- •Long strictures which need a both types of buccal mucosa graft due its length.
- •Refuse to ICT for the patient ou it responsible
结局指标
主要结局
Labial Group Success Rate
时间窗: 6 months
Absence of surgical intervention after prior surgery on patients who received a labial graft.
Latex Catheter Success Rate
时间窗: 6 months
Absence of surgical intervention on patients who used a latex catheter indwelling after prior surgery.
Jugal Group Success Rate
时间窗: 6 months
Absence of surgical intervention after prior surgery on patients who received a inner cheek graft.
Silicon Catheter Success Rate
时间窗: 6 months
Absence of surgical intervention on patients who used a silicon catheter indwelling after prior surgery.
Overall Success Rate
时间窗: 6 months
Absence of surgical intervention after prior surgery
次要结局
- Stricture Localization(24 months)
- Stricture Etiology(24 months)
- Stricture Size(24 months)
- Demographic Data(24 months)
研究者
Rafael Carvalho Ipe da Silva
Principal Investigator, MD
Hospital de Clinicas de Porto Alegre