A Randomized Controlled Trial on the Effect of Topical Phenytoin 2% on Wound Healing After Fistulotomy
试验速览
- 阶段
- 不适用
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Healing
研究概览
简要总结
Patients with anal fistula who will undergo anal fistulotomy will be randomized into one of two groups; the first group will receive topical phenytoin therapy postoperatively and the second group will not receive such topical treatment.
详细描述
Patients with anal fistula who will undergo anal fistulotomy will be randomized into one of two groups; the first group will receive topical phenytoin therapy postoperatively and the second group will not receive such topical treatment.
Healing of the wound after fistulotomy will be observed every week and the duration till complete healing will be recorded. The two groups will be compared regarding the mean duration till complete healing and postoperative complications.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders aging between 18-65 years with primary simple anal fistula (subcutaneous, intersphincteric, or low trans-sphicnteric involving less than 25% of external anal sphincter fibers)
排除标准
- •Patients with high trans-sphincteric, extra-sphincteric, supra-sphincteric, secondary, or recurrent anal fistulas.
- •Patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, and inflammatory bowel diseases.
- •Patients under chronic corticosteriod or immunosuppressive therapy.
研究组 & 干预措施
Phenytoin 2% spray
Patients undergoing anal fistulotomy with postoperative topical phenytoin therapy
干预措施: Phenytoin 2% spray (Drug)
Phenytoin 2% spray
Patients undergoing anal fistulotomy with postoperative topical phenytoin therapy
干预措施: Anal fistulotomy (Procedure)
Anal fistulotomy
Patients undergoing anal fistulotomy without postoperative topical therapy
干预措施: Anal fistulotomy (Procedure)
结局指标
主要结局
Healing
时间窗: 4-8 weeks
Complete epithelilization of the fistulotomy wound without persistent external openings or discharge
次要结局
未报告次要终点
研究者
Sameh Emile
Principal investigator
Mansoura University