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临床试验/NCT04970160
NCT04970160已完成不适用

Rectovestibular Fistula Which Surgical Approaches?

Aswan University Hospital0 个研究点目标入组 84 人开始时间: 2016年1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
84
主要终点
Templeton score

研究概览

简要总结

This study was a prospective, randomized, comparative study that included female children with rectovestibular fistulae who were selected from patients with anorectal malformations treated at the pediatric surgical unit, Assiut University Hospital during the period from January 2016 to February 2020. The patients were randomly divided into four groups according to the procedure performed: trans- sphincter anorectoplasty(TSARP), posterior sagittal anorectoplasty, classic anterior sagittal anorectoplasty (ASARP), and modified ASARP.

详细描述

Background: The management of a vestibular fistula is a challenge for pediatric surgeons. The investigator compared four different operative techniques in terms of postoperative complications, continence, and cosmetic appearance. Patients and methods: This study was a prospective, randomized, comparative study that included female children with rectovestibular fistulae who were selected from patients with anorectal malformations treated at the pediatric surgical unit, Assiut University Hospital during the period from January 2016 to February 2020. The patients were randomly divided into four groups according to the procedure performed: trans- sphincter anorectoplasty(TSARP), posterior sagittal anorectoplasty, classic anterior sagittal anorectoplasty (ASARP), and modified ASARP.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
6 Months 至 12 Years(Child)
性别
Female
接受健康志愿者
否

入选标准

  • •Female children aged 6 months to 12 years who had rectovestibular fistulae that had been treated by a single-stage repair were included in this study.

排除标准

  • •Exclusion criteria were patients with recurrence, previous anorectal surgery.
  • •Patients with anovestibular fistulae.
  • •Patients with rectoperineal fistulas.
  • •Patients with cognitive impairment.

结局指标

主要结局

Templeton score

时间窗: 1 year

The follow up period is up to one year. scheduled dilatation was followed. Data regarding early (up to 2 weeks) complications, such as wound infection, wound dehiscence, and skin excoriation, and delayed (one months to one year) complications, such as mucosal prolapse, fistula formation, and stenosis, were collected. The anorectal function was measured according to age of continence; younger children who had not attained the age of continence (\<3.5 years) had the anocutaneous reflex and anal squeeze on rectal digital examination determined; children older than three and half years had fecal continence rated according to the Templeton score . It designates the operative outcome as "good," "fair," or "poor." The scoring performed prospectively during each follow up visit.

次要结局

  • Anal continence(1year)

研究者

发起方
Aswan University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Magdy

Principle investigator

Aswan University Hospital

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