Cap-assisted Sigmoidoscopy - Influence on Pain, Duration and Rate of Success
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
2 other identifiers
interventional
193
1 country
1
Brief Summary
The purpose of this study is to investigate the attachment of a transparent hood ("cap") on the sigmoidoscope. The investigators hypothesis is that this will reduce pain, reduce investigation time, and increases the success rate of the sigmoidoscopy. The study focus on the less-experienced endoscopist.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Mar 2014
Shorter than P25 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 12, 2014
CompletedFirst Posted
Study publicly available on registry
September 18, 2014
CompletedSeptember 18, 2014
September 1, 2014
4 months
September 12, 2014
September 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
VAS recording of pain
the registration is performed when the endoscopist has advanced the scope to the 60 cm mark.
During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.
Secondary Outcomes (1)
Time
During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.
Other Outcomes (1)
rate of success
During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.
Study Arms (2)
Cap
EXPERIMENTALSigmoidoscopy with cap
No cap
NO INTERVENTIONSigmoidoscopy without cap
Interventions
Eligibility Criteria
You may qualify if:
- planned to undergo sigmoidoscopy
- informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Surgical department, endoscopy unit, Koege Hospital, Denmark
Koege, Region Sjælland, 4600, Denmark
Related Publications (1)
Ploug M, Poulsen JK, Jensen HQ, Achiam M. The use of a transparent cap in sigmoidoscopy-A randomized controlled clinical trial on pain, time and success rate. Indian J Gastroenterol. 2017 Jul;36(4):318-322. doi: 10.1007/s12664-017-0776-y. Epub 2017 Aug 1.
PMID: 28762140DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Magnus Ploug, MD
Koege Hospital, Surgical Department
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Junior Doctor
Study Record Dates
First Submitted
September 12, 2014
First Posted
September 18, 2014
Study Start
March 1, 2014
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
September 18, 2014
Record last verified: 2014-09