Parental Attitudes to Neoanus Dilatations Post-reconstruction in Anorectal Malformations

NCT05749406 | Unknown

• 1 other identifier: 313255
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Anorectal Malformations

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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.

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parents of patients born with an anorectal malformation who have undergone anorectoplasty and been recommended post-operative anal dilatations.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Verity Haffenden: lead

MeSH Terms

Conditions

Anorectal Malformations

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Verity E Haffenden, MSc MBBS MRCS

CONTACT

07920745903; verity.haffenden@gstt.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Fellow in Paediatric Surgery

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: March 1, 2023
• Study Start: July 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share