Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focus group | Other | Small virtual focus group discussion about experiences/attitudes towards post-operative anal dilatation. | ||
| Semi-structured interview | Other | Individual virtual interview to ascertain participant's experiences of performing anal dilatation post-operatively for their child with an anorectal malformation. |
| Measure | Description | Time Frame |
|---|---|---|
| Parental reported experience of anal dilatation | 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. | 3 months |
Not provided
Not provided
Inclusion Criteria:
The parent of any patient who has:
Exclusion Criteria:
The parent of any patient who had has:
Not provided
Not provided
Parents of patients born with an anorectal malformation who have undergone anorectoplasty and been recommended post-operative anal dilatations.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Verity E Haffenden, MSc MBBS MRCS | Contact | 07920745903 | verity.haffenden@gstt.nhs.uk |
Not provided
Not provided
Patient data will not be shared at this stage
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000071056 | Anorectal Malformations |
| ID | Term |
|---|---|
| D004065 | Digestive System Abnormalities |
| D004066 | Digestive System Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| D017144 | Focus Groups |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Not provided
Not provided
Not provided
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |