Parental Attitudes to Neoanus Dilatations Post-reconstruction in Anorectal Malformations

Anorectal Malformations Clinical Trial

— PANDA  

Official title:

Parental Attitudes to Neoanus Dilatations Post-reconstruction in Anorectal Malformations

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05749406
• Other study ID #: 313255
• Status: Not yet recruiting
• Start date: July 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2023
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Verity E Haffenden, MSc MBBS MRCS
• Phone: 07920745903
• Email: verity.haffenden[@]gstt.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorectal Malformations
• Congenital Abnormalities

Intervention

Other:
• Focus group
Small virtual focus group discussion about experiences/attitudes towards post-operative anal dilatation.
• Semi-structured interview
Individual virtual interview to ascertain participant's experiences of performing anal dilatation post-operatively for their child with an anorectal malformation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Verity Haffenden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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