Appendicitis, Child
Conditions
Keywords
Appendectomy, Nonsurgical treatment with antibiotics
Brief summary
This is a feasibility study that will be performed at the Astrid Lindgren Children´s Hospital, Karolinska University Hospital, Stockholm, Sweden. It will involve 50 patients, randomized to either conservative, non-operative, treatment with antibiotics OR surgery. The study will test an computerized randomization system, the availability of patients willing to participate in the trial and the trial protocol. The investigators will assess the characteristics of the patients who agree to participate in the study and those who do not. The investigators will explore short term outcome and design suitable long term outcome measures.
Interventions
PROCEDUREAppendectomy
Standard surgical treatment, normally laparoscopic appendectomy
DRUGConservative, non-surgical treatment
Non-surgical treatment, intravenous and oral antibiotics. Meropenem and Metronidazol will be used as intravenous antibiotics, Ciprofloxacin and Metronidazol will be used as oral antibiotics.
Sponsors
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Children 5-15 years old with a clinical diagnosis of appendicitis that prior to the trial would have been subjected to a surgical intervention
Exclusion criteria
* Suspicion of perforated appendicitis on the basis of generalized peritonitis * An appendiceal mass, diagnosed either by palpation or with radiology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of symptoms without significant complications | 30 days | This outcome measure is designed to be similar between the two groups. It is measured in number of participants that fails its designated treatment. Failure of treatment include abscess formation requiring treatment (prolonged antibiotic course or drainage), wound infection requiring intravenous antibiotics, wound dehiscence requiring treatment, prolonged ileus \>5 days, length of stay \>7 days, recurrent appendicitis, persistance of symptoms leading to surgery and negative appendectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in hospital | 7 days | Number of days as inpatients after initiation of allocated treatment, ea. after randomization. |
| Time to resolution of symptoms | 7 days | In hours, to the time where there is no significant pain (VAS not more than 3), no temprature nor any anorexia. |
| Abscess formation | 7 days | As noted either in hospital or during follow up. |
| Early complications | 7 days | Wound infections, wound dehiscence, diarrhea etc. |
| Pain | 48 hours | Measured after 12, 24 and 48 hours with the 0-10 Visual Analoge Scale. |
Countries
Sweden
Outcome results
None listed