Parental Attitudes to Neoanus Dilatations Post-reconstruction in Anorectal Malformations
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Parental reported experience of anal dilatation
研究概览
简要总结
The goal of this qualitative clinical trial is to learn about parental attitudes and experiences of performing post-operative dilatation anal dilatations for their child with an anorectal malformation. The main question it aims to answer are:
- What are parental experiences/attitudes towards performing anal dilatations post-operatively.
In the first part of the study, participants will take part in a small virtual focus group discussion to identify themes to aid design of a semi-structured interview for part 2. In part 2, participants will undergo a virtual semi-structured interview. The answers will be recorded, anonymised, transcribed and undergo thematic analysis.
详细描述
Babies born without an anal opening require reconstructive surgery to create one, allowing them to pass stools. After the procedure, some surgeons recommend that parents perform routine dilatation of the anal opening using a metal rod dilator called a Hegar dilator. Recent studies have shown no difference in clinical outcomes for patients who have routine anal dilatation and those who do not. This study will look to find out the parental experiences and attitudes towards performing anal dilatation for their child.
The study will be formed of 2 parts. Participants will all be parents who were asked to perform routine anal dilatation post-operatively for their child born with an anorectal malformation. In part 1, a focus group will be conducted via Microsoft teams to ascertain themes to formulate the questions for part 2. In part 2, individual semi-structured interviews will be performed via MS teams. The interviews will be recorded, anonymised, transcribed and undergo analysis to assess for common themes.
The results will be published to guide professionals with regards to best practice and help inform parental discussions for new patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The parent of any patient who has:
- •Undergone a posterior sagittal anorectoplasty for anorectal malformation and been recommended post-operative anal dilatations
- •AND operation performed prior to November 2020
- •AND able to understand and communicate in English
- •AND with access to a mobile/computer with MS Teams
排除标准
- •The parent of any patient who had has:
- •NOT undergone a posterior sagittal anorectoplasty for anorectal malformation
- •AND/OR, NOT been recommended post-operative anal dilatations
- •OR operated on after to November 2020
- •OR unable to understand and communicate in English
- •OR without access to a mobile/computer with access to MS Teams
结局指标
主要结局
Parental reported experience of anal dilatation
时间窗: 3 months
Parental reported experience of anal dilatation; This is a qualitative study that will use thematic analysis to identify parental reported experiences of performing anal dilatations in children. No scale/questionnaire will be used to allow for appropriate breadth of response.
次要结局
未报告次要终点
研究者
Verity Haffenden
Clinical Research Fellow in Paediatric Surgery
Guy's and St Thomas' NHS Foundation Trust