Condition category
Digestive System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
29/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes

29/04/2016: No publications found, verifying study status with principal investigator