Outcomes in ARMs: Comparison Between Surgical Techniques in Patients With Perineal or Vestibular Fistula - a Multicenter Italian Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Fecal Continence at 3 YEARS
研究概览
简要总结
This is a national, multicenter, retro-prospective longitudinal cohort study evaluating mid- and long-term outcomes of different surgical techniques used for the correction of anorectal malformations (ARM) with perineal or vestibular fistula.
Patients undergoing surgical correction between 2020 and 2027 will be included. Functional outcomes, particularly fecal continence assessed using the Krickenbeck score, will be evaluated at 3 and 6 years post-surgery or until continence is achieved.
详细描述
This is a national, multicenter ambispective (retro-prospective) longitudinal cohort study. The study includes patients who underwent surgical correction between 2020 and 2027.
Data collected prior to study activation (2020-study start date) will be analyzed retrospectively from medical records, while patients enrolled after study activation will be followed prospectively with annual assessments until achievement of fecal continence or up to 6 years of age, whichever occurs first.
Anorectal malformations (ARM) are rare congenital anomalies requiring complex reconstructive surgery. Posterior sagittal anorectoplasty (PSARP) remains the gold standard; however, alternative techniques such as anterior sagittal anorectoplasty (ASARP) and transanal proctoplasty (TAP) are increasingly adopted.
This study aims to compare surgical techniques in terms of:
Fecal continence (Krickenbeck score)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 0 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients (<18 years)
- •Diagnosis of anorectal malformation with perineal or vestibular fistula
- •Surgical correction with PSARP (or variants), ASARP, or TAP
- •Signed informed consent from parents/legal guardians
排除标准
- •Age >18 years
- •Other types of anorectal malformations
- •Surgical technique other than those specified
研究组 & 干预措施
PSARP group
Patients undergoing posterior sagittal anorectoplasty (PSARP) or its variants (miniPSARP)
TAP group
Patients undergoing transanal proctoplasty (TAP).
结局指标
主要结局
Fecal Continence at 3 YEARS
时间窗: 3 years post-surgery
Measured by proportion of children achieving fecal continence according to Krickenbeck score.
Fecal Continence at 6 Years
时间窗: 6 years post-surgery
Measured by proportion of children achieving fecal continence according to Krickenbeck score.
次要结局
- Constipation Severity and Bowel Management Requirements(Assessed annually until 6 years of age or achievement of fecal continence)
- Postoperative Complications Within 30 Days(Within 30 days after surgical correction)
- ectal Mucosal Prolapse(From surgery until 6 years of age or achievement of fecal continence (up to 6 years))
- Quality of Life (HAQL Questionnaire)(Assessed annually until 6 years of age or achievement of fecal continence)
- time to Achievement of Fecal Continence(From date of surgery until continence is achieved or up to 6 years of age)
研究者
Riccardo Coletta
MEDICAL DOCTOR
Meyer Children's Hospital IRCCS