PANDA v1.0
Research type
Research Study
Full title
Parental Attitudes to Neo-anus Dilatations post-reconstruction in Anorectal Malformations
IRAS ID
313255
Contact name
Hemanshoo Thakkar
Contact email
Sponsor organisation
Guy's & St Thomas' Foundation NHS Trust
Clinicaltrials.gov Identifier
NCT05749406, clinicaltrials.gov
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This study aims to describe parental attitudes and experiences of performing anal dilatation following reconstructive repair for children with an anorectal malformation. Children born with anorectal malformations are born without a suitable anal canal through which stool can be passed. These children will typically undergo reconstructive surgery at 3-6 months of age during which a "new" anus is formed. In several centres, within the UK and internationally, parents are asked to perform stretching of this new passage with a metal rod called a dilator. This is carried out usually between 1-2 times a day for several weeks until the desired size is achieved. There have been some clinical studies, including a recent trial, showing no difference in clinical outcomes of patients who received dilatations to those who did not. Parents will be eligible to participate if they have a child born with an anorectal malformation, managed at our centre (Evelina London Children’s Hospital) prior to 2020, and were asked to perform post-operative dilatation of the neo-anus. In the first stage of our study they will be invited to participate in a small focus group and, following this, parents will be invited to take part in a semi-structured interview. Data from the interviews will be transcribed and analysed. The results of this study will be used to inform paediatric surgeons of parental perspectives to guide ongoing management decisions.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
23/YH/0169
Date of REC Opinion
27 Sep 2023
REC opinion
Further Information Favourable Opinion