Parental Attitudes to Neoanus Dilatations Post-reconstruction in Anorectal Malformations (NCT05749406) | Clinical Trial Compass
UnknownNot Applicable
Parental Attitudes to Neoanus Dilatations Post-reconstruction in Anorectal Malformations
20 participantsStarted 2023-07-01
Plain-language summary
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:
1\. 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.
Who can participate
Age range
16 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
Exclusion Criteria:
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.