Conservative Treatment of Acute Appendicitis in Children

Appendicitis Clinical Trial

— CONSAPP Pilot  

Official title:

Conservative Treatment of Acute Appendicitis in Children Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01572558
• Other study ID #: EA2011/4:8
• Status: Completed
• Phase: N/A
• First received: February 13, 2012
• Last updated: October 15, 2012
• Start date: February 2012
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appendicitis
• Child

Intervention

Procedure:
• Appendectomy
Standard surgical treatment, normally laparoscopic appendectomy

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.

Locations

Country	Name	City	State
Sweden	Astrid Lindgren Children´s Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days	Yes
Secondary	Time in hospital	Number of days as inpatients after initiation of allocated treatment, ea. after randomization.	7 days	No
Secondary	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.	7 days	No
Secondary	Abscess formation	As noted either in hospital or during follow up.	7 days	Yes
Secondary	Early complications	Wound infections, wound dehiscence, diarrhea etc.	7 days	Yes
Secondary	Pain	Measured after 12, 24 and 48 hours with the 0-10 Visual Analoge Scale.	48 hours	No