Crohn DiseaseLAPCROHNNCT02899013
Description of Perianal Lesions in a Cohort of Crohn's Disease Patients
An observational study of Crohn Disease, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The perianal lesions (LAP) specific for Crohn's disease have been reported in 1938, six years after the first cases of luminal disease. If phenotypic data of the latter are well documented today, those of perianal disease remain inadequately described. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2015to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Crohn's disease diagnosed patients, all confused phenotype
Who may be able to join
- Crohn's disease diagnosed, all confused phenotype
- Perianal reached whatever its phenotype (specific or non-Crohn's disease).
Who cannot join
- Refusal or inability of the patient to be eventually reached by telephone
- Psychiatric pathology and / or non-understanding of the French language making the collection of random data
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
The perianal lesions (LAP) specific for Crohn's disease have been reported in 1938, six years after the first cases of luminal disease. If phenotypic data of the latter are well documented today, those of perianal disease remain inadequately described. The reasons are numerous: understated symptoms by patients, elementary semiotics proctology ignored by practitioners, lack of validated classifications to track these violations and challenges to undertake clinical trials to high standard of proof in view of these variables, etc. ... Moreover, the impact of these LAP varies across studies (10-80%). in addition to the above-mentioned reasons, these results are also due to the different definitions of LAP used in the studies, their collection in reference centers versus tertiary centers, their potential occurrence at any time of disease progression, their greater frequency in case of distal disease (12% for infringement isolated ileal, 15% in breach ileo colic, 41% in case of colonic involvement and 91% in case of rectal involvement). Yet the specific LAP should be better documented because they are a factor of poor prognosis of Crohn's disease.
Read the detailed description
The perianal lesions (LAP) specific for Crohn's disease have been reported in 1938, six years after the first cases of luminal disease. If phenotypic data of the latter are well documented today, those of perianal disease remain inadequately described. The reasons are numerous: understated symptoms by patients, elementary semiotics proctology ignored by practitioners, lack of validated classifications to track these violations and challenges to undertake clinical trials to high standard of proof in view of these variables, etc. ... Moreover, the impact of these LAP varies across studies (10-80%). in addition to the above-mentioned reasons, these results are also due to the different definitions of LAP used in the studies, their collection in reference centers versus tertiary centers, their potential occurrence at any time of disease progression, their greater frequency in case of distal disease (12% for infringement isolated ileal, 15% in breach ileo colic, 41% in case of colonic involvement and 91% in case of rectal involvement). Yet the specific LAP should be better documented because they are a factor of poor prognosis of Crohn's disease.
In practice, Crohn's disease specific LAP are described in the UFS Cardiff classification. She is currently the most used even if the inter-observer reproducibility has never been demonstrated. This is an anatomical and pathophysiological classification distinguishes two types of LAP: primary, specific lesions (cracks and ulcers), and secondary lesions, consequences of mechanical complications (strictures) or infectious (fistulas and abscesses) lesions primary. The cracks are often multiple, broad and deep base and may occur in any quadrant of the anus. They may be painless and are not usually associated with sphincter hypertension. They constitute 20 to 35% of the LAP. Ulcerations realize profound substance of losses, based on an inflammatory tissue banks and have loosened, edematous. They often focus on the sub-pectineal portion of the anal canal and have an extension in height and depth. They are rarer: 5 to 10% of LAP. Stenoses are either functional, due to sphincter spasm and then reversible or organic, short or long fibrous membrane and irreversible. They usually occur after healing of ductal ulcers or abscesses. They represent 35% of the LAP. Fistulas may be secondary to infection of an anal gland Hermann and Desfosses or complicate a crack or anorectal ulcer. These are the most common LAP: 50 to 70%.
The epidemiology of non-specific LAP, ie "non-primary" and "no side", in Crohn's disease patients is even more unclear. However, the management of these lesions in patients at high risk of incontinence and for whom quality of life is affected by their chronic disease should be subject to special precautions. Prevalence of hemorrhoidal disease, estimated at 7% in a recent study, so is probably undervalued. The conservative therapeutic approach is consensus even though some recent studies have shown no complications after hemorrhoidectomy in patients with quiescent disease. Crohn's disease patients also have an excess risk poorly quantified develop various skin lesions anoperineal: secondary lesions to chronic diarrhea, fungal infections, contact dermatitis, paradoxical reactions to anti-TNF, autoimmune diseases associated, etc ... Finally, the effect of immunosuppression on the risk of anal cancer in Crohn's disease patients (with or without LAP) is not clearly known. Several authors have demonstrated an excess risk of infections Papillomavirus and intraepithelial neoplastic lesions of the anus in transplant treated with azathioprine and there is a risk of degeneration in severe injuries, and old chronicles. Monitoring could therefore be necessary in these sub-immune suppressor patients in the long term but there are currently no recommendations.
In short, the specific LAP or not Crohn's disease are poorly understood although their presence worsens the quality of life of patients and in some cases, is a factor of poor prognosis luminal disease. The purpose of this study is to describe the set of LAP (including specific or non-inflammatory disease lesions) in a cohort of patients with Crohn's disease.
Study Objectives
- accurately describe the LAP primary, secondary and "non-primary, not secondary" Crohn's patient cohort and obtain data including:
- The type of injury
- Their proportion
- The treatment they have already been
- Their impact on anal continence
- Their impact on quality of life
- Their field occurrence
- The phenotypic profile of the associated luminal disease.
- establish a possible causal link between certain lesions and certain treatments.
- identify some injuries possibly worse prognosis.
Methodology
- non-interventional study
- prospective cohort.
- multicenter recruitment.
- Data collection in two steps:
- In consultation:
- initials, sex and patient age
- phone
- tobaccological profile
- potential obstetric and surgical history
- intestinal transit (across Bristol)
- Data from the proctology examination (nonspecific lesions and classification UFS Cardiff)
- activity profile of specific LAP (PDAI score Irvine)
- impact of LAP on anal incontinence (Wexner score)
- phenotypic profile of the luminal disease (classification of Montreal)
- activity profile of luminal disease (Harvey-Bradshaw Index)
- impact on quality of life (GIQLI the questionnaire)
- previous treatments, current or proposed amendment if, Crohn's disease and LAP
- serum CRP.
- By phone, if necessary, in a second time to complete any missing data.
- Conditions
- Crohn Disease
- Being tested
- No intervention
- Keywords
- Perianal Lesions
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational study to describe Perianal Lesions in a Cohort of Crohn's Disease Patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of PDAI Score
activity profile of specific LAP (PDAI score of Irvine)
Measured: Day 15
Secondary outcomes (4)
Assessment of Wexner score
impact of LAP on anal incontinence (Wexner score)
Measured: Day 15
Assessment of phenotypic profile of the luminal disease (classification of Montreal)
Assessment of phenotypic profile of the luminal disease (classification of Montreal)
Measured: Day 15
Assessment of Harvey-Bradshaw Index
activity profile of luminal disease (Harvey-Bradshaw Index)
Measured: Day 15
Assessment of quality of life by GIQLI questionary
impact on quality of life (GIQLI questionary)
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899013
- Sponsor's protocol ID
- LAPCROHN
- Acronym
- LAPCROHN
- Status last verified
- Sep 2017
- First submitted
- 8 Sep 2016
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of Perianal Lesions in a Cohort of Crohn's Disease Patients
- ClinicalTrials.gov ID
- NCT02899013
- Acronym / sponsor ID
- LAPCROHN / LAPCROHN
- Conditions
- Crohn Disease
- Keywords
- Perianal Lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Sep 2016 (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 perianal lesions (LAP) specific for Crohn's disease have been reported in 1938, six years after the first cases of luminal disease. If phenotypic data of the latter are well documented today, those of perianal disease remain inadequately described. The reasons are numerous: understated symptoms by patients, elementary semiotics proctology ignored by practitioners, lack of validated classifications to track these violations and challenges to undertake clinical trials to high standard of proof in view of these variables, etc. ... Moreover, the impact of these LAP varies across studies (10-80%). in addition to the above-mentioned reasons, these results are also due to the different definitions of LAP used in the studies, their collection in reference centers versus tertiary centers, their potential occurrence at any time of disease progression, their greater frequency in case of distal disease (12% for infringement isolated ileal, 15% in breach ileo colic, 41% in case of colonic involvement and 91% in case of rectal involvement). Yet the specific LAP should be better documented because they are a factor of poor prognosis of Crohn's disease.
Detailed description
The perianal lesions (LAP) specific for Crohn's disease have been reported in 1938, six years after the first cases of luminal disease. If phenotypic data of the latter are well documented today, those of perianal disease remain inadequately described. The reasons are numerous: understated symptoms by patients, elementary semiotics proctology ignored by practitioners, lack of validated classifications to track these violations and challenges to undertake clinical trials to high standard of proof in view of these variables, etc. ... Moreover, the impact of these LAP varies across studies (10-80%). in addition to the above-mentioned reasons, these results are also due to the different definitions of LAP used in the studies, their collection in reference centers versus tertiary centers, their potential occurrence at any time of disease progression, their greater frequency in case of distal disease (12% for infringement isolated ileal, 15% in breach ileo colic, 41% in case of colonic involvement and 91% in case of rectal involvement). Yet the specific LAP should be better documented because they are a factor of poor prognosis of Crohn's disease.
In practice, Crohn's disease specific LAP are described in the UFS Cardiff classification. She is currently the most used even if the inter-observer reproducibility has never been demonstrated. This is an anatomical and pathophysiological classification distinguishes two types of LAP: primary, specific lesions (cracks and ulcers), and secondary lesions, consequences of mechanical complications (strictures) or infectious (fistulas and abscesses) lesions primary. The cracks are often multiple, broad and deep base and may occur in any quadrant of the anus. They may be painless and are not usually associated with sphincter hypertension. They constitute 20 to 35% of the LAP. Ulcerations realize profound substance of losses, based on an inflammatory tissue banks and have loosened, edematous. They often focus on the sub-pectineal portion of the anal canal and have an extension in height and depth. They are rarer: 5 to 10% of LAP. Stenoses are either functional, due to sphincter spasm and then reversible or organic, short or long fibrous membrane and irreversible. They usually occur after healing of ductal ulcers or abscesses. They represent 35% of the LAP. Fistulas may be secondary to infection of an anal gland Hermann and Desfosses or complicate a crack or anorectal ulcer. These are the most common LAP: 50 to 70%.
The epidemiology of non-specific LAP, ie "non-primary" and "no side", in Crohn's disease patients is even more unclear. However, the management of these lesions in patients at high risk of incontinence and for whom quality of life is affected by their chronic disease should be subject to special precautions. Prevalence of hemorrhoidal disease, estimated at 7% in a recent study, so is probably undervalued. The conservative therapeutic approach is consensus even though some recent studies have shown no complications after hemorrhoidectomy in patients with quiescent disease. Crohn's disease patients also have an excess risk poorly quantified develop various skin lesions anoperineal: secondary lesions to chronic diarrhea, fungal infections, contact dermatitis, paradoxical reactions to anti-TNF, autoimmune diseases associated, etc ... Finally, the effect of immunosuppression on the risk of anal cancer in Crohn's disease patients (with or without LAP) is not clearly known. Several authors have demonstrated an excess risk of infections Papillomavirus and intraepithelial neoplastic lesions of the anus in transplant treated with azathioprine and there is a risk of degeneration in severe injuries, and old chronicles. Monitoring could therefore be necessary in these sub-immune suppressor patients in the long term but there are currently no recommendations.
In short, the specific LAP or not Crohn's disease are poorly understood although their presence worsens the quality of life of patients and in some cases, is a factor of poor prognosis luminal disease. The purpose of this study is to describe the set of LAP (including specific or non-inflammatory disease lesions) in a cohort of patients with Crohn's disease.
Study Objectives
- accurately describe the LAP primary, secondary and "non-primary, not secondary" Crohn's patient cohort and obtain data including:
- The type of injury
- Their proportion
- The treatment they have already been
- Their impact on anal continence
- Their impact on quality of life
- Their field occurrence
- The phenotypic profile of the associated luminal disease.
- establish a possible causal link between certain lesions and certain treatments.
- identify some injuries possibly worse prognosis.
Methodology
- non-interventional study
- prospective cohort.
- multicenter recruitment.
- Data collection in two steps:
- In consultation:
- initials, sex and patient age
- phone
- tobaccological profile
- potential obstetric and surgical history
- intestinal transit (across Bristol)
- Data from the proctology examination (nonspecific lesions and classification UFS Cardiff)
- activity profile of specific LAP (PDAI score Irvine)
- impact of LAP on anal incontinence (Wexner score)
- phenotypic profile of the luminal disease (classification of Montreal)
- activity profile of luminal disease (Harvey-Bradshaw Index)
- impact on quality of life (GIQLI the questionnaire)
- previous treatments, current or proposed amendment if, Crohn's disease and LAP
- serum CRP.
- By phone, if necessary, in a second time to complete any missing data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Crohn's disease diagnosed patients, all confused phenotype
Key inclusion criteria (2 listed)
- Crohn's disease diagnosed, all confused phenotype
- Perianal reached whatever its phenotype (specific or non-Crohn's disease).
Key exclusion criteria (2 listed)
- Refusal or inability of the patient to be eventually reached by telephone
- Psychiatric pathology and / or non-understanding of the French language making the collection of random data
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 |
|---|---|---|
| No interventionObservational study to describe Perianal Lesions in a Cohort of Crohn's Disease Patients. | Other | – |
Primary outcome
Assessment of PDAI Score
Time frame: Day 15
activity profile of specific LAP (PDAI score of Irvine)
4 secondary outcomes
Assessment of Wexner score
Time frame: Day 15
Assessment of phenotypic profile of the luminal disease (classification of Montreal)
Time frame: Day 15
Assessment of Harvey-Bradshaw Index
Time frame: Day 15
Assessment of quality of life by GIQLI questionary
Time frame: Day 15
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 8 Sep 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Crohn Disease, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 2 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 8 Sep 2017. 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 France. 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?
Assessment of PDAI Score (time frame: Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2017.