Conservative Treatment of Acute Appendicitis in Children (CONSAPP Pilot)
|ClinicalTrials.gov Identifier: NCT01572558|
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : October 17, 2012
|Condition or disease||Intervention/treatment||Phase|
|Appendicitis Child||Procedure: Appendectomy Drug: Conservative, non-surgical treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Conservative Treatment of Acute Appendicitis in Children Pilot Trial|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572558
|Astrid Lindgren Children´s Hospital|
|Stockholm, Sweden, 17176|
|Principal Investigator:||Jan F Svensson, MD||Karolinska Institutet|