|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT02243930 |
|
Date of registration:
|
12/09/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Cap-assisted Sigmoidoscopy - Influence on Pain, Duration and Rate of Success
|
|
Scientific title:
|
Cap-assisted Sigmoidoscopy - Reduction in Pain, Reduction in Investigation Time and Increased Rate of Success, When Examined by the Less-experienced Endoscopist. A Prospective Randomized Clinical Trial |
|
Date of first enrolment:
|
March 2014 |
|
Target sample size:
|
193 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT02243930 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Denmark
| | | | | | | |
|
Contacts
|
|
Name:
|
Magnus Ploug, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Koege Hospital, Surgical Department |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- planned to undergo sigmoidoscopy
- informed consent
Exclusion Criteria:
- use of iv medication for pain and/or anxiety immediately before the endoscopy
- lack of indication for a full sigmoidoscopy (eg just need to investigate the rectum)
- lack or improper administration of standard bowel preparation
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Pain
|
|
Intervention(s)
|
|
Device: Disposable distal attachment
|
|
Primary Outcome(s)
|
|
VAS recording of pain
[Time Frame: During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.]
|
|
Secondary Outcome(s)
|
|
Time
[Time Frame: During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.]
|
|
Secondary ID(s)
|
|
KOESURG-41580
|
|
41580
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|