PainNCT02243930
Cap-assisted Sigmoidoscopy - Influence on Pain, Duration and Rate of Success
A study testing Disposable distal attachment in people with Pain, run by Zealand University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Disposable distal attachment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- planned to undergo sigmoidoscopy
- informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Surgical department, endoscopy unit, Koege Hospital, Denmark
Koege, Region Sjælland, 4600
About this study
Official 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
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.
Read the detailed description
The investigators randomize study subject to sigmoidoscopy +/- the attachment of the cap.
Using a 100mm VAS scale the investigators record pain when the sigmoidoscopy reaches its intubation end-point (60cm from anus). The investigators also register the time spent to this point and the rate of examinations not achieving this endpoint.
- Conditions
- Pain
- Being tested
- Disposable distal attachment
- Keywords
- Sigmoidoscopy with or without cap, Pain during sigmoidoscopy, Sigmoidoscopy and time
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disposable distal attachmentDevice
Also called "cap", Model No. D-201-14304 - Olympus, Dimentions: Ø15,0mm
| Study group | Role | What they receive |
|---|---|---|
| Cap | Experimental | Sigmoidoscopy with cap Receives: Device: Disposable distal attachment |
| No cap | No intervention | Sigmoidoscopy without cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS recording of pain
the registration is performed when the endoscopist has advanced the scope to the 60 cm mark.
Measured: During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.
Secondary outcomes (1)
Time
Recording of the time it takes from the introduction of the endoscopy through anus until it reaches 60 cm intubation mark.
Measured: During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, magnus Ploug, Zealand University Hospital
- Investigators
- Magnus Ploug, MD, Principal investigator, Koege Hospital, Surgical Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243930
- Sponsor's protocol ID
- KOESURG-41580
- Other IDs
- 41580
- Status last verified
- Sep 2014
- First submitted
- 12 Sep 2014
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28762140
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02243930
- Acronym / sponsor ID
- KOESURG-41580
- Conditions
- Pain
- Keywords
- Sigmoidoscopy with or without cap, Pain during sigmoidoscopy, Sigmoidoscopy and time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 18 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators randomize study subject to sigmoidoscopy +/- the attachment of the cap.
Using a 100mm VAS scale the investigators record pain when the sigmoidoscopy reaches its intubation end-point (60cm from anus). The investigators also register the time spent to this point and the rate of examinations not achieving this endpoint.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cap | Experimental | Device: Disposable distal attachmentSigmoidoscopy with cap |
| No cap | No intervention | –Sigmoidoscopy without cap |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- planned to undergo sigmoidoscopy
- informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disposable distal attachmentAlso: "cap", Model No. D-201-14304 - Olympus, Dimentions: Ø15,0mm | Device | Cap |
Primary outcome
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.
the registration is performed when the endoscopist has advanced the scope to the 60 cm mark.
1 secondary outcome
Time
Time frame: During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2014.
- Derived from this study: PubMed 28762140Ploug 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magnus Ploug, MD principal investigator
Koege Hospital, Surgical Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disposable distal attachment in people with Pain, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02243930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2014; AzTrials last refreshed its copy on 6 Nov 2026.