The objective of this research is to see if this way of treating a patient ensures a quicker diagnosis, which results in lessabdominal pain for the patient.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is diminished acute abdominal pain, this will be measured
during the anamnesis and physical
examination by using the *comfort scale* or the VAS-measurement and the ammount
of used painkillers.
Secondary outcome
The time needed for reaching the final diagnosis.
Background summary
In children presented with acute abdominal pain, a relative substantial group
remains with a nonspecific cause. A
suggested part of this group suffers from acute or chronic constipation.
The diagnose of constipation is difficult, because it needs multiple
evaluations, inclusive abdominal x-rays and various
histories of last defecations time. Laxantives are the treatment of choice for
constipation.
Study objective
The objective of this research is to see if this way of treating a patient
ensures a quicker diagnosis, which results in less
abdominal pain for the patient.
Study design
A randomized control interventional trial with and without treatment
Intervention
If there is still doubt after clinical examination and laboratory results
(where an additional blood sample is taken) if the patient has appendicitis,
then he or she will be randomised. In this study half of the patient group will
receive laxantives and clysmata, which is the treatment for constipation. The
other half of the group will not receive a treatment in the meantime. Both
groups will be asked to come back the next day for a
new clinical examination. During the clinical examination the pain score will
be measured by using the "comfort scale" or
the VAS measurement, also the ammount of use of painkillers will be analyzed
Study burden and risks
For this study the patients who have constipation benefits from the given
intervention, because laxantives and clysmata is
the standard treatment for constipation. Laxantives and clysmata are not a
burden for the health of the children.
Substudy:
The extra blood sample of 6 ml will be collected with the routine blood
sampling which takes place in all children with
suspected appendicitis. Therefore, no extra venapuncture is necessary.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
All patients between 5 and 18 years, who are referred by first line health care with the suspicion of acute appendicitis.
Exclusion criteria
Severe co-morbidity like malignancy, resent abdominal surgery and known inflammatory bowl disease.
Pregnancy
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2013-000498-56-NL |
| CCMO | NL44710.042.13 |