Mucosal ErosionCSCNCT01574547
Risk Factors of Cat Scratch Colon Developing.
An observational study of Mucosal Erosion, run by University Hospital of the Nuestra Señora de Candelaria.
Trial summary
This study was designed to: estimate the incidence of cat scratch colon in the investigators environment; explore the diseases associated to its development; identify the factors related to its development; and assess its clinical repercussions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mucosal Erosion
- How many people
- 10,715 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Apr 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All of the ambulatory colonoscopies performed at our Hospital
Who may be able to join
- All of the ambulatory colonoscopies performed at our University Hospita
Who cannot join
- Patients thats refused.
About this study
This study was designed to: estimate the incidence of cat scratch colon in the investigators environment; explore the diseases associated to its development; identify the factors related to its development; and assess its clinical repercussions.
Read the detailed description
All of the ambulatory colonoscopies performed at the investigators University Hospital from September 2007 were prospectively included in the study. Data recorded for each patient included: age, sex, disease background, reason for the examination, hematological data and the endoscopic diagnosis.
Every patient presenting CSC lesions had colon biopsies taken. These were studied by a single anatomic pathologist specializing in gastrointestinal pathologies.
The characteristics (age, sex, disease background, indication for surgery, age at the time of surgery, time elapsed since surgery, hematological data and pathoanatomical study of the colon biopsies) of diversion colitis patients with and without CSC lesions will bi compared.
- Conditions
- Mucosal Erosion
- Keywords
- Cat Scratch Colon., Mucosal tears., Mucosal erosion., Colonoscopy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cat Scratch Colon | Patients with mucosal tears during colonoscopy | |
| Control group | Patients without mucosal tears during the colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of cat scratch colon during the endoscopy
Cat Scratch Colon: spontaneous tears appearing in the colon mucosa during colonoscopy
Measured: at the moment of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startSep 2007
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Mucosal ErosionStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10,715 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of the Nuestra Señora de Candelaria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan-Salvador Baudet, University Hospital of the Nuestra Señora de Candelaria
- Investigators
- Juan-salvador Baudet, M.D., Principal investigator, Ntra. Sra. de Candelaria University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574547
- Sponsor's protocol ID
- Dig-3
- Acronym
- CSC
- Status last verified
- Apr 2012
- First submitted
- 8 Apr 2012
- Last updated
- 10 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McDonnell WM, Loura F, Pointon MJ, Greenson JK. Cat scratch colon. Endoscopy. 2007 May;39(5):459-61. doi: 10.1055/s-2007-966266.
PubMed 17516354Cruz-Correa M, Milligan F, Giardiello FM, Bayless TM, Torbenson M, Yardley JH, Jackson FW, Wilson Jackson F. Collagenous colitis with mucosal tears on endoscopic insufflation: a unique presentation. Gut. 2002 Oct;51(4):600. doi: 10.1136/gut.51.4.600. No abstract available.
PubMed 12235088Yarze JC. Finding mucosal tears in collagenous colitis during colonoscopic insufflation. Gut. 2003 Apr;52(4):613-4; author reply 614. doi: 10.1136/gut.52.4.613-a. No abstract available.
PubMed 12631685Hata K, Watanabe T, Kanazawa T, Kazama S, Shida D, Nagawa H. Mucosal tears on endoscopic insufflation. Gut. 2003 Apr;52(4):613; author reply 613. doi: 10.1136/gut.52.4.613. No abstract available.
PubMed 12631686Mitchell JD, Teague R, Bolton R, Lowes J. Submucosal "dissection" in collagenous colitis. Gut. 2004 Mar;53(3):470. No abstract available.
PubMed 14960541Wickbom A, Lindqvist M, Bohr J, Ung KA, Bergman J, Eriksson S, Tysk C. Colonic mucosal tears in collagenous colitis. Scand J Gastroenterol. 2006 Jun;41(6):726-9. doi: 10.1080/00365520500453473.
PubMed 16716973Freeman HJ. Complications of collagenous colitis. World J Gastroenterol. 2008 Mar 21;14(11):1643-5. doi: 10.3748/wjg.14.1643.
PubMed 18350593van Velden R, Snieders I, Quispel R. Image of the month. Tearing of the colon in a patient with collagenous colitis during colonoscopy. Clin Gastroenterol Hepatol. 2010 Nov;8(11):A28. doi: 10.1016/j.cgh.2010.06.002. Epub 2010 Jun 25. No abstract available.
PubMed 20601144Baudet JS, Diaz-Bethencourt D, Arguinarena X, Soler M, Morales S, Aviles J. Cat scratch colon is caused by barotrauma secondary to insufflation during colonoscopy. Endoscopy. 2008 Oct;40(10):878; author reply 878-9. doi: 10.1055/s-2008-1077562. Epub 2008 Sep 30. No abstract available.
PubMed 18828090Baudet JS, Arguinarena X, Diaz-Bethencourt D, Soler M, Aviles J. [Cat scratch colon. A little known condition]. Rev Esp Enferm Dig. 2008 Dec;100(12):790-1. doi: 10.4321/s1130-01082008001200010. No abstract available. Spanish.
PubMed 19222340Purnak T, Ozaslan E, Yildiz A, Efe C. The cat scratch colon sign in a patient with chronic cholestasis. Endoscopy. 2010;42 Suppl 2:E117. doi: 10.1055/s-0029-1243983. Epub 2010 Mar 19. No abstract available.
PubMed 20306401Sherman A, Ackert JJ, Rajapaksa R, West AB, Oweity T. Fractured colon: an endoscopically distinctive lesion associated with colonic perforation following colonoscopy in patients with collagenous colitis. J Clin Gastroenterol. 2004 Apr;38(4):341-5. doi: 10.1097/00004836-200404000-00008.
PubMed 15087693
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Cat Scratch Colon Developing.
- ClinicalTrials.gov ID
- NCT01574547
- Acronym / sponsor ID
- CSC / Dig-3
- Conditions
- Mucosal Erosion
- Keywords
- Cat Scratch Colon., Mucosal tears., Mucosal erosion., Colonoscopy.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,715 participants (actual)
- Lead sponsor
- University Hospital of the Nuestra Señora de CandelariaUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 10 Apr 2012 (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.
This study was designed to: estimate the incidence of cat scratch colon in the investigators environment; explore the diseases associated to its development; identify the factors related to its development; and assess its clinical repercussions.
Detailed description
All of the ambulatory colonoscopies performed at the investigators University Hospital from September 2007 were prospectively included in the study. Data recorded for each patient included: age, sex, disease background, reason for the examination, hematological data and the endoscopic diagnosis.
Every patient presenting CSC lesions had colon biopsies taken. These were studied by a single anatomic pathologist specializing in gastrointestinal pathologies.
The characteristics (age, sex, disease background, indication for surgery, age at the time of surgery, time elapsed since surgery, hematological data and pathoanatomical study of the colon biopsies) of diversion colitis patients with and without CSC lesions will bi compared.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cat Scratch Colon | – | –Patients with mucosal tears during colonoscopy |
| Control group | – | –Patients without mucosal tears during the colonoscopy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All of the ambulatory colonoscopies performed at our Hospital
Key inclusion criteria (1 listed)
- All of the ambulatory colonoscopies performed at our University Hospita
Key exclusion criteria (1 listed)
- Patients thats refused.
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
Presence of cat scratch colon during the endoscopy
Time frame: at the moment of colonoscopy
Cat Scratch Colon: spontaneous tears appearing in the colon mucosa during colonoscopy
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 10 Apr 2012.
- Background: PubMed 17516354McDonnell WM, Loura F, Pointon MJ, Greenson JK. Cat scratch colon. Endoscopy. 2007 May;39(5):459-61. doi: 10.1055/s-2007-966266.
- Background: PubMed 12235088Cruz-Correa M, Milligan F, Giardiello FM, Bayless TM, Torbenson M, Yardley JH, Jackson FW, Wilson Jackson F. Collagenous colitis with mucosal tears on endoscopic insufflation: a unique presentation. Gut. 2002 Oct;51(4):600. doi: 10.1136/gut.51.4.600. No abstract available.
- Background: PubMed 12631685Yarze JC. Finding mucosal tears in collagenous colitis during colonoscopic insufflation. Gut. 2003 Apr;52(4):613-4; author reply 614. doi: 10.1136/gut.52.4.613-a. No abstract available.
- Background: PubMed 12631686Hata K, Watanabe T, Kanazawa T, Kazama S, Shida D, Nagawa H. Mucosal tears on endoscopic insufflation. Gut. 2003 Apr;52(4):613; author reply 613. doi: 10.1136/gut.52.4.613. No abstract available.
- Background: PubMed 14960541Mitchell JD, Teague R, Bolton R, Lowes J. Submucosal "dissection" in collagenous colitis. Gut. 2004 Mar;53(3):470. No abstract available.
- Background: PubMed 16716973Wickbom A, Lindqvist M, Bohr J, Ung KA, Bergman J, Eriksson S, Tysk C. Colonic mucosal tears in collagenous colitis. Scand J Gastroenterol. 2006 Jun;41(6):726-9. doi: 10.1080/00365520500453473.
- Background: PubMed 18350593Freeman HJ. Complications of collagenous colitis. World J Gastroenterol. 2008 Mar 21;14(11):1643-5. doi: 10.3748/wjg.14.1643.
- Background: PubMed 20601144van Velden R, Snieders I, Quispel R. Image of the month. Tearing of the colon in a patient with collagenous colitis during colonoscopy. Clin Gastroenterol Hepatol. 2010 Nov;8(11):A28. doi: 10.1016/j.cgh.2010.06.002. Epub 2010 Jun 25. No abstract available.
- Background: PubMed 18828090Baudet JS, Diaz-Bethencourt D, Arguinarena X, Soler M, Morales S, Aviles J. Cat scratch colon is caused by barotrauma secondary to insufflation during colonoscopy. Endoscopy. 2008 Oct;40(10):878; author reply 878-9. doi: 10.1055/s-2008-1077562. Epub 2008 Sep 30. No abstract available.
- Background: PubMed 19222340Baudet JS, Arguinarena X, Diaz-Bethencourt D, Soler M, Aviles J. [Cat scratch colon. A little known condition]. Rev Esp Enferm Dig. 2008 Dec;100(12):790-1. doi: 10.4321/s1130-01082008001200010. No abstract available. Spanish.
- Background: PubMed 20306401Purnak T, Ozaslan E, Yildiz A, Efe C. The cat scratch colon sign in a patient with chronic cholestasis. Endoscopy. 2010;42 Suppl 2:E117. doi: 10.1055/s-0029-1243983. Epub 2010 Mar 19. No abstract available.
- Background: PubMed 15087693Sherman A, Ackert JJ, Rajapaksa R, West AB, Oweity T. Fractured colon: an endoscopically distinctive lesion associated with colonic perforation following colonoscopy in patients with collagenous colitis. J Clin Gastroenterol. 2004 Apr;38(4):341-5. doi: 10.1097/00004836-200404000-00008.
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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.
Juan-salvador Baudet, M.D. principal investigator
Ntra. Sra. de Candelaria University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Mucosal Erosion, run by University Hospital of the Nuestra Señora de Candelaria.
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 1 inclusion and 1 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 10 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Presence of cat scratch colon during the endoscopy (time frame: at the moment of colonoscopy). 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 NCT01574547, which also lists 12 linked publications.
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 10 Apr 2012.