Efficacy of Platelet-rich Plasma on Perianal Wound Healing After Anal Fistulotomy: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- complete wound healing
研究概览
简要总结
This randomized controlled study aims to investigate the effect of injection of platelet rich plasma on the postoperative outcome of perianal wound after anal fistula surgery in terms of healing time, reduction in wound size, pain score , and therefore quality of patients' life.
详细描述
Fistula-in-ano is an epithelial-lined tract connecting the anal canal to the perianal skin. Most commonly, it affects people in the third to fifth decades of life.
Anal fistula arise spontaneously, when it is referred to as idiopathic or cryptoglandular, or as a result of an underlying pathology, such as inflammatory bowel disease, malignancy, trauma or irradiation.
The majority of anal fistula often occurs following anorectal abscess. An anorectal abscess occurs when an anal gland becomes obstructed, resulting in infection and abscess formation. One-third of patients undergoing incision and drainage of an anorectal abscess will later develop a fistula. Thirty to 70% of patients diagnosed with an anorectal abscess will already have a fistula present on exam.
According to the relation of fistulous track to the sphincter complex, anal fistulas can be classified as simple or complex. Simple anal fistula includes low transsphincteric and intersphincteric fistulas that cross less than 30% of the external sphincter fibers. On the other hand, complex anal fistulas comprise, high transsphincteric fistulas, suprasphincteric, extrasphincteric fistulas, and horseshoe fistulas.
Patients with anal fistula often complain of perianal cellulitis, anorectal pain, pruritus ani, smelly or bloody drainage of pus, and in some cases difficulty controlling bowel movements.
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, Investigator)
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
- •Both genders
- •Aging between 18-65 years
- •Presented by simple anal fistula (subcutaneous, intersphincteric, or low trans-sphicnteric involving less than 30% of external anal sphincter fibers)
排除标准
- •Patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases.
- •Patients on long-acting corticosteroids or immunosuppressive drugs
- •Patients having connective tissue diseases
- •Patients with complex anal fistula.
结局指标
主要结局
complete wound healing
时间窗: from day 1 post operative to maximally 6 months
duration in days required to achieve complete healing of the anal wound in both groups on postoperative follow-up
次要结局
- pain score(from 6 hours postoperative to 2 months)
研究者
Mirna Mohamed Elsaid
assistant lecturer of general surgery
Mansoura University
