PainNCT01496560
Open Prospective Study for Determination of Predictive Measures for Pain During Colonoscopy
An observational study of Pain, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The aim of the study is to determine what precolonoscopic measures can be correlated to pain during colonoscopy Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2015to Nov 2015
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing screening colonoscopy
Who may be able to join
- age 18-70
- screening colonoscopy
Who cannot join
- Failed prior colonoscopy
- pain as a main referral indication
- complications during previous exam
- Inpatients
- Excision of more than 3 polyps
- Diagnosis ofCancer, IBD
- Incomplete exam
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Procedural Sequence in Same Day Consecutive Bidirectional Endoscopy Using Moderate Sedation: A Prospective Randomized Study
The aim of the study is to determine what precolonoscopic measures can be correlated to pain during colonoscopy
Read the detailed description
The aim of the work is to determine prdictive pre-endoscopic factors for pain during colonoscpy. These factors may be demographic, antrophometric, socio-ecomomic, related to previous medical staus or to anxiety levels.
We will try to find an objective parameter for prdiction of pain during colonoscopy, so pre-procedural intervantion will be applied in order to reduce the pain.
- Conditions
- Pain
- Keywords
- colonoscopy, pain, rectal balloon
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-endoscopic Rectal balloon volumes
Volume for first sensation, desire to deficate and maximal tolerance volume
Measured: 1 year
Secondary outcomes (2)
Demographic data
Demographic data related to excessive pain
Measured: 1 year
Pre-endocopic levels of anxiety
Relation of Pre-endoscopic levels of anxiety to pain during colonoscopy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startNov 2015
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: study terminated due toTechnical issue pre -recruiting
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 Sheba Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Dan Carter, Gastroenterologist, Sheba Medical Center
- Investigators
- Dan Carter, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496560
- Sponsor's protocol ID
- Sheba-11-8679-DC-CTIL
- Status last verified
- Nov 2015
- First submitted
- 19 Dec 2011
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Park DI, Kim HJ, Park JH, Cho YK, Sohn CI, Jeon WK, Kim BI, Ryu SH, Sung IK. Factors affecting abdominal pain during colonoscopy. Eur J Gastroenterol Hepatol. 2007 Aug;19(8):695-9. doi: 10.1097/01.meg.0000219097.32811.24.
PubMed 17625440
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Procedural Sequence in Same Day Consecutive Bidirectional Endoscopy Using Moderate Sedation: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01496560
- Acronym / sponsor ID
- Sheba-11-8679-DC-CTIL
- Conditions
- Pain
- Keywords
- colonoscopy, pain, rectal balloon
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: study terminated due toTechnical issue pre -recruiting
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Nov 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 21 Dec 2011 (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 aim of the study is to determine what precolonoscopic measures can be correlated to pain during colonoscopy
Detailed description
The aim of the work is to determine prdictive pre-endoscopic factors for pain during colonoscpy. These factors may be demographic, antrophometric, socio-ecomomic, related to previous medical staus or to anxiety levels.
We will try to find an objective parameter for prdiction of pain during colonoscopy, so pre-procedural intervantion will be applied in order to reduce the pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing screening colonoscopy
Key inclusion criteria (2 listed)
- age 18-70
- screening colonoscopy
Key exclusion criteria (7 listed)
- Failed prior colonoscopy
- pain as a main referral indication
- complications during previous exam
- Inpatients
- Excision of more than 3 polyps
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pre-endoscopic Rectal balloon volumes
Time frame: 1 year
Volume for first sensation, desire to deficate and maximal tolerance volume
2 secondary outcomes
Demographic data
Time frame: 1 year
Pre-endocopic levels of anxiety
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
- Background: PubMed 17625440Park DI, Kim HJ, Park JH, Cho YK, Sohn CI, Jeon WK, Kim BI, Ryu SH, Sung IK. Factors affecting abdominal pain during colonoscopy. Eur J Gastroenterol Hepatol. 2007 Aug;19(8):695-9. doi: 10.1097/01.meg.0000219097.32811.24.
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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.
Dan Carter, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Sheba Medical Center at 1 site in Israel.
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 7 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: withdrawn, as of the sponsor's last update on 17 Nov 2015. 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 Israel. 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 was withdrawn before enrolling participants, so there are no results.
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?
Pre-endoscopic Rectal balloon volumes (time frame: 1 year). 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 NCT01496560, 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 17 Nov 2015.