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临床试验/NCT02313597
NCT02313597已完成不适用

Outcomes in High Perianal Fistula Repair Using Video-assisted Anal Fistula Treatment Compared With Seton Use: a Randomized Controlled Trial

Dr. SamiUllah2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2014年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Number of Participants With Recurrence of Disease or Fistula

研究概览

简要总结

Anal fistula is the most common Peri anal disease. It's a disease with an incidence of 9 in 100,000. Anal fistula is classified on the basis of its location into high and low anal fistula, above or below dentate line respectively.

Multiple series have shown that the formation of a fistula tract following anorectal abscess occurs in 7-40% of cases. There are typically 8-10 anal crypt glands at the level of the dentate line in the anal canal arranged circumstantially. These glands afford a path for infecting organisms to reach the intramuscular spaces. The cryptoglandular hypothesis states that an infection begins in the anal canal glands and progresses into the muscular wall of the anal sphincters to cause an anorectal abscess.

According to internal opening many author proposed certain classification but the standardized in all of them is Park's classification, so this study categorized the patient through this classification. There are four types of fistula-in-ano in Park's Classification intersphincteric (between internal and external sphincters is 70%), transsphincteric (across external sphincters is 25%), suprasphincteric (over sphincters), and extrasphincteric(above and through levator ani).High anal fistula is considered to be difficult to treat because of its location.This study diagnosed the internal opening of high perianal with the help of endoluminal ultrasound and MRI.

Classic method of its treatment are fistulotomy, fistulectomy and Setone placement but these are associated with lots of complication like fecal incontinence,recurrence,pain.Therefore many method have been recently devised including Ligation of intersphincteric fistula tract (Lift), glue repair and flap advancement.Another recently introduced method for its treatment is Video-assisted anal fistula treatment (VAAFT) proposed by P. Meinero which has been associated with less 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
Single (Outcomes Assessor)

入排标准

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of either gender with age ranging from 15 to 60 years.
  • All patients with high anal fistula

排除标准

  • Patients with suspected malignancy determined by the presence of a mass on digital rectal examination,
  • History of previous perianal surgery,
  • History of irritable bowel disease determined by medical record
  • Uncontrolled diabetes

结局指标

主要结局

Number of Participants With Recurrence of Disease or Fistula

时间窗: 3 years postoperatively

Number of Participants with Recurrence of Disease or Fistula 3 Years After Treatment

次要结局

  • Time to Healing of Fistula(up to 12 weeks)
  • Time to Return to Work(up to 4 weeks)
  • Duration of Surgery(Time from beginning of surgery to end of surgery,assessed up to 180 minutes)
  • Pain Score(12 hours after surgery)

研究者

发起方
Dr. SamiUllah
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Dr. SamiUllah

Medical Officer

Services Hospital, Lahore

研究点 (2)

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