1.To prospectively evaluate the course of anorectal function in IBD patients with perianal lesions2.To establish potential biomarkers to predict the course of anorectal function in IBD patients with perianal lesions
ID
Source
Brief title
Condition
- Anal and rectal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Changes of anorectal pressures assessed by anal manometry, rectal compliance
measurement and anal endosonography
- Clinical symptoms:
* faecal incontinence measured by Vaizey and Wexner scores
Secondary outcome
- Prognostic factors of alteration of anorectal function using the Montreal
classification (age, location, behavior and perianal disease), gender, surgery,
family history of IBD and smoking habit.
- Quality of life measured by QLQ-SF36 and IBDQ, and the morbidity caused by
perianal Crohn*s disease measured by PDAI
Background summary
Crohn*s disease (CD) and ulcerative colitis (UC) form part of the group
idiopathic chronic inflammatory bowel diseases (IBD). Perianal lesions are an
important clinical feature of CD. Less is known about the correlation between
perianal lesions and UC. A high prevalence of perianal complications in UC
patients has been described before 1966 due to the fact that those patients may
likely had CD instead of UC. However, it is apparent that patients with clear
cut UC may suffer from perianal problems.
It is not clear why some patients develop perianal lesions and others do not.
Too understand more about the pathophysiology of perianal lesions, anorectal
function may play a role. Data about anorectal pressures are conflicting.
Altered anorectal pressures appear to be diminished in many patients with CD.
One study showed an increased anal pressure and rectal sensitivity in patients
in absence of anorectal inflammation, which can compromise the anal
circulation. This may increase infection risk in the anal region and the
development of fistulas. Contrastingly, in a previous study, we showed a
statistically significant lower maximum resting pressure in CD patients
compared with healthy volunteers.
Study objective
1.To prospectively evaluate the course of anorectal function in IBD patients
with perianal lesions
2.To establish potential biomarkers to predict the course of anorectal function
in IBD patients with perianal lesions
Study design
All patients with IBD and complaints of perianal function and anorectal
dysfunction were analyzed by means of anorectal function tests and anal
ultrasound in the period 1993-1999. In total 56 patients underwent anorectal
function tests.
These patients will be approached to fill in a questionnaires concerning
quality of life and anorectal function. They will be invited for a follow-up
perianal examination and anorectal function investigation. These test results
will be compared with the first test results.
Study burden and risks
No specific ethical problems exist. Patients will be informed about the study
and asked for consent. Some patients may feel uncomfortable about answering
questions regarding incontinence. To reduce this problem, the questionnaires
will be sent to the patients to be filled in private setting.
The anorectal examinations are easy to perform and well tolerated by patients.
It requires no bowel preparation. The investigation takes only a few minutes.
Anorectal function tests and EUS can be considered as a safe, economic
procedure. Furthermore, all patients had these test previously.
In addition, patients with complaints can be seen in our outpatient clinic to
consider treatment.
De Boelelaan 1118
1081 HZ Amsterdam
Nederland
De Boelelaan 1118
1081 HZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Patients with IBD who had at least one anorectal function test between 1993-1999 in our Department of Gastroenterology
Exclusion criteria
Females who are pregnant or had a delivery < 6 months.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL28067.029.09 |