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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Standard surgical treatment, normally laparoscopic appendectomy
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.
Astrid Lindgren Children´s Hospital
Stockholm, Sweden
Resolution of symptoms without significant complications
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.
Time frame: 30 days
Time in hospital
Number of days as inpatients after initiation of allocated treatment, ea. after randomization.
Time frame: 7 days
Time to resolution of symptoms
In hours, to the time where there is no significant pain (VAS not more than 3), no temprature nor any anorexia.
Time frame: 7 days
Abscess formation
As noted either in hospital or during follow up.
Time frame: 7 days
Early complications
Wound infections, wound dehiscence, diarrhea etc.
Time frame: 7 days
Pain
Measured after 12, 24 and 48 hours with the 0-10 Visual Analoge Scale.
Time frame: 48 hours
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