Randomised controlled trial of injection of botulinum toxin into the internal anal sphincter versus control in treatment of chronic idiopathic constipation in children
| ISRCTN | ISRCTN24521269 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24521269 |
| Secondary identifying numbers | N0013146059 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 16/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr Graham Clayden
Scientific
Scientific
Sherman Education Centre
F04 Thomas Guy House
Guy's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom
| Phone | +44 (0)20 7188 4593 |
|---|---|
| Graham.clayden@kcl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| 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(s) | Not provided at time of registration |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Botulinum toxin |
| Primary outcome measure | Improvement in patients symptom severity score determined by parents completed questionnaire. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 08/10/2003 |
| Overall study end date | 01/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 80 |
| Participant inclusion criteria | 80 children with idiopathic chronic constipation referred for anorectal manometry and inpatient bowel management programme. |
| 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
- England
- United Kingdom
Study participating centre
Guy's Hospital
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Guy's and St. Thomas' NHS Foundation Trust (UK) Own account NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
16/04/2018: No publications found, study status unverified.
10/03/2016: No publications found, verifying study status with principal investigator
