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

Anorectal Malformations Clinical Trial

Official title: Parental Attitudes to Neoanus Dilatations Post-reconstruction in Anorectal Malformations

Status Not yet recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anorectal Malformations
• Congenital Abnormalities

• NCT number: NCT05749406
• Study type: Observational
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Verity E Haffenden, MSc MBBS MRCS
• Phone: 07920745903
• Email: verity.haffenden@gstt.nhs.uk
• Status: Not yet recruiting
• Start date: July 1, 2023
• Completion date: July 1, 2024