A multicentre pragmatic clinical investigation to assess the efficacy of TransiCap MRI marker devices in magnetic resonance imaging when used to determine whole gut transit time, and inform treatment selection in paediatric constipatio

Not Applicable

Completed

• Conditions: Paediatric constipation; Digestive System; Constipation

• Registration Number: ISRCTN42273449
• Lead Sponsor: ottingham University Hospitals NHS Trust

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33093366/ (added 08/07/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-02
• Study Completion: 2022-10-02
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 436

Inclusion Criteria

1. Children aged 7 – 18 years old
2. Able to give assent/consent or have a parent/carer able to give informed consent
3. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the clinical investigation
4. Children diagnosed with clinical diagnosis of constipation

Exclusion Criteria

1. Female participants who are pregnant, lactating or planning pregnancy during the course of the clinical investigation. This will be self-reported
2. Any history of gastrointestinal surgery that could affect gastrointestinal function, such as colectomy or small bowel resection
3. Existing ACE procedure before the first MRI scan
4. Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
5. Inability to lie flat and relatively still for less than 5 minutes
6. Poor understanding of English language
7. The following disease or disorder: bowel stricture disease, Crohn’s or any difficulty in swallowing (dysphagia), Hirschsprung disease, congenital anorectal malformations, paediatric pseudo-obstruction syndrome
8. Currently using the following drugs influencing drug motility:
8.1. Opioid analgesics (tramadol, morphine, fentanyl, oxycodone, co-codamol and codydramoland)
8.2. Antispasmodic Buscopan (hyoscine butylbromide, also known as scopolamine butylbromide)
9. Participants who have participated in another research clinical investigation involving an investigational product in the past 12 weeks.
10. 4 or more bowel movements in one week and no episodes of bowel incontinence in one week (if these are reported in the participant’s medical notes. Absence of this information should not warrant exclusion)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment success, defined as 3 or more bowel movements in one week and/or 1 or fewer episodes of bowel incontinence in one week, between the MRI-informed treatment versus standard treatment at 12 months after the final MRI visit (+/- 2 weeks). This will be measured using a patient stool diary at 12 months follow-up.