Our main objective is to investigate the mechanisms that regulate anorectal physiology.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Because we hypothesize that the physiological regulatory mechanisms of
anorectal function are located in the anal (sub)mucosa, we will compare all the
physiological parameters obtained during anorectal function tests performed
under two conditions: with an active superficial anal mucosa, and after its
inactivation. In this way we will be able to indicate the regulatory factors,
and also prove that that they are located in the anal mucosa or submucosa,
which will be the outcome of this study.
Secondary outcome
Not applicable.
Background summary
Constipation is currently one of the most common digestive complaints in the
Western world. Since the physiology of the defecation process in healthy people
is not clear, it is still impossible to efficiently diagnose and treat
constipation.
Study objective
Our main objective is to investigate the mechanisms that regulate anorectal
physiology.
Study design
This study is an invasive intervention study in healthy human subjects.
All participants will undergo two times the following test session, existing of
the following standard anorectal function tests:
• The anal electro sensitivity test
• The anal pressure test
• The recto-anal inhibition reflex test
• The balloon retention test
• The defaecometry test
• The Barostat test
• The rectal infusion test
During the first session, the participants will be measured without applying
local anesthesia. Prior to the identical, second test session we will apply
local anesthesia to the anal canal of the participant. The anesthetic will be
applied randomized: 20 participants will receive a placebo, which does not
contain the anesthetic component.
Intervention
During the second testsession, we will apply the local anaesthetic or placebo
to the anal canal of the participant. After approximately 15 minutes, we will
start with the anorectal function tests.
Study burden and risks
There are no risks associated with study participation.
All anorectal function tests are standard tests used internationally, performed
by an experienced nurse and/or have been previously approved by the medical
ethics committee of the University Medical Center Groningen.
The local, superficial anesthetic that is used to anesthetize the anal canal,
is a generally accepted anesthetic. However, we will inform the participants
about a possible mild incontinence for approximately four hours after the test
session, which is very unlikely because all participants need to use an enema
the day before undergoing the anorectal function tests.
With the results of this study, new insights in the physiologic function of the
anorectum will be gained. Having a complete view of the regulatory mechanisms
of defecation process in healthy subjects, it will be possible to recognize any
abnormalities in these defecation mechanism in patients with defecation
problems. In this way, improvement of the existing diagnostics and treatment of
chronically constipated patients will be possible.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
All subjects must be aged > 18 years.
Exclusion criteria
A potential subject with self-report of bowel problems in a checklist, medical history of congenital abnormalities of the anorectal area, neurological dysfunction, current pregnancy and/or trauma or surgery on the gastrointestinal tract or pelvic floor with a possible influence on anorectal function, will be excluded from analysis.
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 | NL58969.042.16 |