Home » Trials » SLCTR/2009/002
A comparative study of the techniques of terminal ileal intubation at colonoscopy
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SLCTR Registration Number
SLCTR/2009/002
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
A comparative study of the techniques of terminal ileal intubation at colonoscopy
Public Title of Trial
A comparative study of the techniques of terminal ileal intubation at colonoscopy
Disease or Health Condition(s) Studied
Chronic diarrhoea , Inflammatory Bowel Disease, Polyp surveillance
Scientific Acronym
None
Public Acronym
None
Brief title
Ileal intubation
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
P05/01/2009 (Ethics Review Committee of the Faculty of Medicine, University of Kelaniya)
What is the research question being addressed?
Comparing standards ileo-caecal valve intubation technique with a new technique. ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Other
Study Phase
Not Available
Intervention(s) planned
Prospective randomized study, conducted at Endoscopy Unit of Professorial Medical Unit of the Colombo North Teaching Hospital ,Ragama. From above screening population one hundred and fifty consecutive consenting patients with successful colonoscopy. will be randomized to the best current ileal intubation technique or the new techinque (Routine colonoscopy with ileal intubation)
Inclusion criteria
Need for the colonoscopy absence of the exclusion criteria
Exclusion criteria
Age below 18years or above 70 years pregnancy intolerance to Pethidine or Midazolam
Primary outcome(s)
|
1.
Ileal intubation time, Patients satisfaction |
[ During colonscopy ] |
Secondary outcome(s)
|
1.
None |
[] |
Target number/sample size
150
Countries of recruitment
Sri Lanka
Anticipated start date
2009-02-28
Anticipated end date
2010-02-28
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2009-01-19
Approval number
P05/01/2009
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Arjuna Priyadarsin de Silva
Senior Lecturer, Department of Medicine
Faculty of Medicine ,PO Box:06, Thalagolla Road, Ragama, Sri Lanka
0777572379
2958737
apdsilva@yahoo.com
Contact Person for Public Queries
Arjuna Priyadarsin de Silva
Senior Lecturer, Department of Medicine
Faculty of Medicine ,PO Box:06, Thalagolla Road, Ragama, Sri Lanka
0777572379
2958737
apdsilva@yahoo.com
Primary study sponsor/organization
Arjuna Priyadarsin de Silva
Thalagolla Road, Ragama, Sri Lanka
0777572379
2958737
apdsilva@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
