Conservative Treatment of Acute Appendicitis in Children (CONSAPP Pilot)
|Appendicitis Child||Procedure: Appendectomy Drug: Conservative, non-surgical treatment|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Conservative Treatment of Acute Appendicitis in Children Pilot Trial|
- Resolution of symptoms without significant complications [ Time Frame: 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.
- Time in hospital [ Time Frame: 7 days ]Number of days as inpatients after initiation of allocated treatment, ea. after randomization.
- Time to resolution of symptoms [ Time Frame: 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 [ Time Frame: 7 days ]As noted either in hospital or during follow up.
- Early complications [ Time Frame: 7 days ]Wound infections, wound dehiscence, diarrhea etc.
- Pain [ Time Frame: 48 hours ]Measured after 12, 24 and 48 hours with the 0-10 Visual Analoge Scale.
|Study Start Date:||February 2012|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Appendectomy
Standard surgical treatment, appendectomy
Standard surgical treatment, normally laparoscopic appendectomy
Experimental: Conservative, non-surgical treatment
Non-operative treatment with intravenous and oral antibiotics
Drug: Conservative, 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572558
|Astrid Lindgren Children´s Hospital|
|Stockholm, Sweden, 17176|
|Principal Investigator:||Jan F Svensson, MD||Karolinska Institutet|