Comparison of the cleansing efficacy of two different bowel preparations for colonoscopy
| ISRCTN | ISRCTN84197329 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84197329 |
| Secondary identifying numbers | N0065117310 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 16/12/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr EH Sherkawi
Scientific
Scientific
Department of General Surgery
Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | Comparison of the cleansing efficacy of two different bowel preparations for colonoscopy |
| Study objectives | To identify the best or the most effective of the two bowel preparation regimes for successful completion of colonoscopy (Picolax, compared to Picolax and Senna). |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Colonoscopy |
| Intervention | Operator-blinded prospective study with the use of questionnaires comparing the colonoscopy failure rate due to poor bowel preparation associated with the two different laxative regimes (Picolax and Placebo, compared to Picolax and Senna). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | icolax and Senna |
| Primary outcome measure | Completion colonoscopy rates (by reaching the caecum) |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 30/12/2002 |
| Completion date | 01/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 187 patients in each treatment group, 374 in total |
| Key inclusion criteria | A total of 374 patients aged above 18 and below 80 are to be recruited. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 30/12/2002 |
| Date of final enrolment | 01/12/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Sunderland Royal Hospital
Sunderland
SR4 7TP
United Kingdom
SR4 7TP
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
City Hospitals Sunderland NHS Trust (UK)
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 |
