Parental Attitudes to Neoanus Dilatations Post-reconstruction in Anorectal Malformations (PANDA)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anorectal Malformations
• Intervention / Treatment: Other: Focus group; Other: Semi-structured interview

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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Verity E Haffenden, MSc MBBS MRCS; Phone Number: 07920745903; Email: verity.haffenden@gstt.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Verity Haffenden

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Anorectal Malformations
• Other Study ID Numbers: 313255

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patient data will not be shared at this stage

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No