Anorectal MalformationsPANDANCT05749406
Parental Attitudes to Neoanus Dilatations Post-reconstruction in Anorectal Malformations
An observational study of Anorectal Malformations, run by Verity Haffenden.
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. Read more about this study
- Who is it for?
- Ages 16 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Anorectal Malformations
- What is being tested?
- Focus group and Semi-structured interview
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Parents of patients born with an anorectal malformation who have undergone anorectoplasty and been recommended post-operative anal dilatations.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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:
- 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.
Read the 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.
- Conditions
- Anorectal Malformations
- Being tested
- Focus group, Semi-structured interview
- Medical subject headings
- Anorectal Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus groupOther
Small virtual focus group discussion about experiences/attitudes towards post-operative anal dilatation.
Semi-structured interviewOther
Individual virtual interview to ascertain participant's experiences of performing anal dilatation post-operatively for their child with an anorectal malformation.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorectal MalformationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Verity Haffenden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Verity Haffenden, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749406
- Sponsor's protocol ID
- 313255
- Acronym
- PANDA
- Status last verified
- May 2023
- First submitted
- 13 Dec 2022
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data will not be shared at this stage
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Attitudes to Neoanus Dilatations Post-reconstruction in Anorectal Malformations
- ClinicalTrials.gov ID
- NCT05749406
- Acronym / sponsor ID
- PANDA / 313255
- Conditions
- Anorectal Malformations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Verity HaffendenUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parents of patients born with an anorectal malformation who have undergone anorectoplasty and been recommended post-operative anal dilatations.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus groupSmall virtual focus group discussion about experiences/attitudes towards post-operative anal dilatation. | Other | – |
| Semi-structured interviewIndividual virtual interview to ascertain participant's experiences of performing anal dilatation post-operatively for their child with an anorectal malformation. | Other | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: No. Patient data will not be shared at this stage
Related trials for Anorectal Malformations
Not yet recruiting
Comparison of a New Non-invasive Device With the Invasive Gold-standard Investigation to Assess Function of the Large Bowel in Children
Bowel Dysfunction, Dysmotility
Not yet recruiting
Effectiveness of Electrical Stimulation and Biofeedback on Fecal Incontinence in Children With Repaired Anorectal Malformation
Fecal Incontinence (FI), Anorectal Malformations
Recruiting
Oral Antibiotics vs. No Antibiotics in Pediatric Colorectal Surgery
Bowel Cleansing Prior to Clinical Procedures, Colorectal Anastomosis
Enrolling by invitationObservational study
Long-Term Health Outcomes in Children Born With Hirschsprung's Disease and Anorectal Malformations at the Colorectal Centre of Excellence in Quebec
Anorectal Malformation, Hirschprung's Disease
RecruitingObservational study
Outcomes in ARMs: Comparison Between Surgical Techniques in Patients With Perineal or Vestibular Fistula - a Multicenter Italian Study
Anorectal Malformations
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorectal Malformations, run by Verity Haffenden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Verity E Haffenden, MSc MBBS MRCS (07920745903, verity.haffenden@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental reported experience of anal dilatation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.