Contact information
Type
Scientific
Primary contact
Dr Susan Protheroe
ORCID ID
Contact details
Birmingham Children's Hospital
Department of Gastroenterology
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom
+44 (0)121 333 8720
Sue.protheroe@bch.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0045126756
Study information
Scientific title
Introduction of a community-based intervention for children with chronic constipation
Acronym
Study hypothesis
To assess the effect of the introduction of a primary care-based intervention for children with constipation compared to conventional hospital based management.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Digestive System: Constipation
Intervention
A randomised controlled trial to compare a new nurse-led service with conventional hospital-based management for children with constipation.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Clinical outcomes: remission and relapse of symptoms
2. Quality of life/patient and parental satisfaction
3. Cost benefits: on-going treatment, nurse contacts, out-patient visits and hospital admission
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2003
Overall trial end date
31/03/2004
Reason abandoned
Eligibility
Participant inclusion criteria
40 children aged 2-15 years with moderate to severe chronic constipation referred to gastroenterologists and general paediatricians in Birmingham Children's Hospital NHS Trust.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
40
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/04/2003
Recruitment end date
31/03/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Birmingham Children's Hospital
Birmingham
B4 6NH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Birmingham Children's Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary