Condition category
Digestive System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
10/03/2016
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 Graham Clayden

ORCID ID

Contact details

Sherman Education Centre
F04 Thomas Guy House
Guy's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom
+44 (0)20 7188 4593
Graham.clayden@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0013146059

Study information

Scientific title

Randomised controlled trial of injection of botulinum toxin into the internal anal sphincter versus control in treatment of chronic idiopathic constipation in children

Acronym

Study hypothesis

To investigate the role of needle-free injection of botulinum toxin into external anal sphincter versus injection of the toxin into internal anal sphincter using ordinary needle versus control

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 randomized-controlled trial of botulinum toxin injection versus control in children with chronic idiopathic constipation. The children are randomly allocated by surgeons into two treatment groups after anorectal manometry under ketamine anaesthetic:
Group 1 = injection of botulinum toxin into the internal anal sphincter
Group 2 = the control group who would have the benefits from the hospital admission to have anorectal studies, manual evacuation of stool if necessary, intensification of laxative treatment and toilet training but no botulinum toxin treatment.

Intervention type

Drug

Phase

Not Applicable

Drug names

Botulinum toxin

Primary outcome measures

Improvement in patients symptom severity score determined by parents completed questionnaire.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

08/10/2003

Overall trial end date

01/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

80 children with idiopathic chronic constipation referred for anorectal manometry and inpatient bowel management programme.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Patients younger than 3 years old or older than 16 years
2. Severe learning difficulty
3. Evidence of Hirschsprungs disease on anorectal manometry
4. Previous anal surgery

Recruitment start date

08/10/2003

Recruitment end date

01/05/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Guy's Hospital
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

Guy's and St. Thomas' NHS Foundation Trust (UK) Own account NHS R&D Support Funding

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

10/03/2016: No publications found, verifying study status with principal investigator