Effect of Phenytoin Cream on Wound Healing After Anal Fissure Surgery; a Randomized Controlled Trail.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The duration of healing of anal fissure.
研究概览
简要总结
This study aims to compare the effect of phenytoin cream on wound healing after anal fissure surgery compared to control group.
详细描述
Introduction Anal fissure is defined as an elliptical or longitudinal tear in the anoderm distal to the dentate line, exactly proximal to or at the level of the anal verge . It is one of the most painful anal disorders that inversely affect the life quality of the patients .
Acute anal fissure is a simple rupture in the anoderm existing for less than two months and it is associated with anal pain, spasm, and/or bleeding with defecation. Chronic anal fissure is present for more than six weeks and it is characterized by exposed fibers of internal anal sphincters at the base, hypertrophied anal papilla proximally, and a skin tag or sentinel pile .
Conservative methods are likely to fail and have a higher failure rate with chronically recurring anal fissures. In these situations, the gold standard is the internal sphincterotomy. This surgical procedure treats chronic fissure by preventing hypertonia of the internal sphincter .
Wound healing is an essential step during the procedure of post-operative care after anal surgery . For example, it is believed that a desirable wound healing could help reduce the post-operative pain after hemorrhoidectomy, which quite commonly causes delayed patient discharge .
However, due to the unusual circumstance, the wound healing after anal surgery is frequently delayed by postoperative complications, such as bleeding, infection and edema, despite the use of wound healing creams . Therefore, it is still necessary to investigate more efficient therapeutic regimen to accelerate the postoperative wound healing after anal surgery.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes,
- •Aged between 18 and 65 years old,
- •with chronic anal fissure after failure of previous conservative treatment.
排除标准
- •surgically unfit patients due to multiple comorbidities,
- •patients with concomitant other anorectal pathology,
- •patient with anal fissure secondary to inflammatory bowel disease,
- •patients with active anorectal sepsis
- •patients with previous anal surgery .
研究组 & 干预措施
Topical anal phenytoin cream application
local application of phenytoin cream on anal wound post internal sphincterotomy for chronic anal fissure.
干预措施: phenytoin cream (Drug)
control arm
includes those with internal sphincterotomy but without application of topical phenytoin cream
干预措施: no phenytoin cream (Drug)
结局指标
主要结局
The duration of healing of anal fissure.
时间窗: 21 to 30 days
The primary endpoint will be the duration of healing of anal fissure in days. It will be defined as complete epithelization of the anal wound.
次要结局
- post operative complications and others(14 to 21 days)
研究者
Ahmad Sakr
principal investigator
Mansoura University Hospital
