Ligation of Intersphincteric Fistula Tract (LIFT) With or Without Injection of Bone Marrow Mononuclear Cells in Treatment of Trans-sphincteric Anal Fistula; a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Number of patients with complete healing of anal fistula as assessed by clinical examination
研究概览
简要总结
To improve the outcome of LIFT, some authors used a combined approach of LIFT. Pooled analysis of seven studies including 192 patients revealed a success rate of 83.5 % after combined LIFT approach. The use of bone marrow aspirate concentrate (BMAC) in surgery is not entirely new as it has been widely used in the treatment of bone defects, mandibular reconstruction, maxillary sinus augmentation and in critical limb ischemia.
A previous study concluded that the use of BMAC to augment external anal sphincter repair strengthens wound healing by transferring cells responsible for healing directly to the site of repair. The current study aimed to assess the outcome of local injection of bone marrow mononuclear cells (BM-MNCs) in conjunction with LIFT as compared to LIFT alone in regards to healing rate, time to healing, and ultimate success rate.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients of either gender presented with cryptoglandular trans-sphincteric anal fistula
排除标准
- •Patients with secondary anal fistula
- •Immunocompromised patients
- •Patients with previous pelvic radiotherapy
- •Pregnant women
- •Patients with ASA (American society of anesthesiologists) III or higher.
结局指标
主要结局
Number of patients with complete healing of anal fistula as assessed by clinical examination
时间窗: 6 months
Healing is defined as complete epithelization of the anal wound with absence of fistula tract
次要结局
未报告次要终点
研究者
Sameh Emile
Associate professor of surgery
Mansoura University