Conservative Treatment of Acute Appendicitis in Children

Not Applicable

Completed

• Conditions: Appendicitis; Child
• Interventions: Procedure: Appendectomy; Drug: Conservative, non-surgical treatment

• Registration Number: NCT01572558
• Lead Sponsor: Karolinska University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-13
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-06
• Status Verified: 2012-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Last Update Submitted: 2012-10-15
• Last Update Posted: 2012-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Appendectomy	Appendectomy	Standard surgical treatment, appendectomy
Conservative, non-surgical treatment	Conservative, non-surgical treatment	Non-operative treatment with intravenous and oral antibiotics

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Early complications	7 days	Wound infections, wound dehiscence, diarrhea etc.
Time in hospital	7 days	Number of days as inpatients after initiation of allocated treatment, ea. after randomization.
Pain	48 hours	Measured after 12, 24 and 48 hours with the 0-10 Visual Analoge Scale.
Abscess formation	7 days	As noted either in hospital or during follow up.

Trial Locations

Locations (1)

Astrid Lindgren Children´s Hospital; 🇸🇪 Stockholm, Sweden