Comparision of surgical outcome and donor-site morbidity between everted great saphenous vein graft versus lingual muscosal graft use during substitution urethrosplasty in male patients of anterior urethral strictures along with oral submucous fibrosis: A randomized, open label, parallel group clinical trial.
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
- 1
- 主要终点
- 2. To compare graft harvest site related morbidities between everted great saphenous vein graft and lingual mucosal graft substitution urethroplasty in male patients of anterior urethral strictures along with tobacco/ areca nut exposed oral submucous fibrosis.
研究概览
简要总结
Buccal mucosal graft is currently the graft of choice for all substitution urethroplasties for urethral stricture disease. It is now considered the gold standard graft. Oral submucosal fibrosis is very common in India due to the use of tobacco products, areca nut and nutritional deficiency. Chronic tobacco and areca nut exposed buccal mucosa make it unsuitable for use in urethral reconstruction surgeries due to reported higher failure rate and donor site morbidity. Lingual mucosal graft now has been used more frequently in Asian countries than the western countries due to the limited availability of buccal mucosa from severe oral submucosal fibrosis associated with prolonged oral tobacco and areca nut use. Although early clinical data show use of lingual mucosa in urethral reconstruction achieves equal success to buccal mucosa, larger studies with longer follow-up are needed to confirm these findings. Lingual mucosal graft harvest-site morbidity should also be considered when treating long strictures, as there is no established safe graft length and larger grafts may cause long-term speech and eating disabilities. In the quest for suitable alternate grafts for urethral substitution in tobacco-exposed oral mucosa; the use of saphenous vein graft has been revived after a few favorable reports of usage in hypospadias surgery. Initial success was demonstrated in rabbit experimental models. Recently the success of substitution urethroplasty using saphenous vein graft in humans is comparable to buccal mucosal graft found in a study conducted in India. In this study, we will explore the feasibility of substitution urethroplasty using great saphenous vein graft in male patients of anterior urethral strictures along with oral submucous fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male patients aged between 18-75 years.
- •Planned for substitution urethroplasty for anterior urethral stricture >2cm length.
- •Oral submucosal fibrosis with history of oral tobacco/ areca nut use.
排除标准
- •Previous history of urethroplasty.
- •History of deep vein thrombosis or venous insufficiency in lower limbs.
- •Near-obliterative strictures (urethral caliber <8 Fr).
- •Presence of two separate strictures requiring separate grafts.
- •Body Mass Index (BMI) ≥
- •Patients who refuse/ withdraw from the study.
结局指标
主要结局
2. To compare graft harvest site related morbidities between everted great saphenous vein graft and lingual mucosal graft substitution urethroplasty in male patients of anterior urethral strictures along with tobacco/ areca nut exposed oral submucous fibrosis.
时间窗: Day-1 | Day-3 | Day-5 | 1-Month | 3-Month | 6-Month | 1-Year
1. To compare surgical outcome between everted great saphenous vein graft and lingual mucosal graft substitution urethroplasty in male patients of anterior urethral strictures along with tobacco/ areca nut exposed oral submucous fibrosis.
时间窗: Day-1 | Day-3 | Day-5 | 1-Month | 3-Month | 6-Month | 1-Year
次要结局
- 1. To compare erectile function between everted great saphenous vein graft and lingual mucosal graft substitution urethroplasty in male patients of anterior urethral strictures along with tobacco/ areca nut exposed oral submucous fibrosis.(1-Month)