1. Immunology and Pathology:To determine the immune response of patients with simple and complex appendicitis in order to identify markers which distinguish between simple and complex appendicitis.2.Clinical and Imaging:To analyze the differences in…
ID
Source
Brief title
Condition
- Gastrointestinal infections
- Bacterial infectious disorders
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Type of appendicitis, gender, age, symptoms at time of presentation, duration
of abdominal pain, fever, heart rate, laboratory results at the time of
diagnosis, findings on radiological imaging. Per operative findings and
conclusion.
Immunology: levels of cytokines, kind of leucocytes in peripheral blood samples.
Histopathology: number and kind of immune cells in the appendix. Cellular
staining by flowcytometry
Bacteriology: Microbiome
Secondary outcome
nvt
Background summary
It appears that there are two types of appendicitis: simple appendicitis (not
perforating) and complex appendicitis (perforating). Current literature
suggests that treatment strategies of the two types should be different.
Therefore correct preoperative diagnosis is crucial to optimize the treatment
of patients with appendicitis. The exact pathogenesis of each type remains
unclear, but there is evidence that the immune system may play a crucial role.
The aim of this study is twofold. First we want to investigate the immune
response of patients with both simple and complex appendicitis. Second, this
study aims to develop an instrument usable in the emergency room to distinguish
simple from complex appendicitis
Study objective
1. Immunology and Pathology:
To determine the immune response of patients with simple and complex
appendicitis in order to identify markers which distinguish between simple and
complex appendicitis.
2.Clinical and Imaging:
To analyze the differences in symptoms, laboratory results and ultrasound
features of both simple and complex appendicitis in children with histological
proven appendicitis in both university and general hospital setting
To develop an instrument usable in the emergency department to distinguish
simple from complex appendicitis preoperatively
To prospectively validate this instrument in a cohort of patients
Study design
Prospective multi centre cohort study.
Study burden and risks
Burden: Common practise is to take a blood sample from the patient with
suspected appendicitis to evaluate the levels of C-reactive protein and
leucocytes (and differentiation). For our study an extra amount of blood
(1.5ml; heparin tube) will be taken and frozen for analysis of the cytokines
profile. In addition the rest of the study will not lead to an extra burden.
The patient will be diagnosed and treated for their suspected appendicitis as
normal (i.e. blood sample and imaging studies and appendectomy). After our
primary analysis of differences between simple and complex appendicitis a tool
will be made. Prior to surgery, the admitting surgeon should note if based on
our tool the patient has a simple or complex appendicitis. The intraoperative
diagnosis will afterwards be checked. Rectal swab during general anaesthesia is
considered a low burden. It is normal to remove the appendix during
appendectomy and sent it for histopathologic examination. We will now take 1 cm
from the tip for bacteriologic and immunologic analysis.
Risks: There is a small chance that blood will be taken, but we will not
analyse this blood sample in this study. Blood will be stored and may be used
for further studies. Smaal chance of missing carcinoid.
Benefit:
Individual: none
Group: The benefit of this study will be that patients can be diagnosed
correctly preoperatively with either simple or complex appendicitis and that
treatment strategies can be optimized based on their diagnosis.
De boelelaan 1117
Amsterdam 1081HV
NL
De boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
3.1 Population (base)
All children 0-17 presenting at the ER department in one of the three hospitals with the suspicion of an acute appendicitis are eligible for inclusion.;3.2 Inclusion criteria (in the simple or complex appendicitis group)
All children 0-17 presenting at the ER department in one of the three hospitals with the suspicion of an acute appendicitis are eligible for inclusion.;3.3 Control group
Children presenting at the ER with abdominal pain with the suspicion of acute appendicitis, although non-infectional cause or no cause was found however.
Exclusion criteria
Age older than 17 years old
Appendicular infiltrate
Appendectomy a froid
Appendix Sana
Malignancy of the appendix
Non-operative management
Abdominal pain caused by other infectious disease such as lymphadenitis mesenteric, pneumonia etcetera.
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 | NL51312.029.14 |