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Clinical Trials/NCT05749406
NCT05749406
Not yet recruiting
Not Applicable

Parental Attitudes to Neoanus Dilatations Post-reconstruction in Anorectal Malformations

Verity Haffenden0 sites20 target enrollmentJuly 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anorectal Malformations
Sponsor
Verity Haffenden
Enrollment
20
Primary Endpoint
Parental reported experience of anal dilatation
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2023
End Date
July 1, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Verity Haffenden
Responsible Party
Sponsor Investigator
Principal Investigator

Verity Haffenden

Clinical Research Fellow in Paediatric Surgery

Guy's and St Thomas' NHS Foundation Trust

Eligibility Criteria

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

Outcomes

Primary Outcomes

Parental reported experience of anal dilatation

Time Frame: 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.

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