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Conservative Treatment of Acute Appendicitis in Children

Information source: Karolinska University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Appendicitis; Child

Intervention: Appendectomy (Procedure); Conservative, non-surgical treatment (Drug)

Phase: N/A

Status: Completed

Sponsored by: Karolinska University Hospital

Official(s) and/or principal investigator(s):
Jan F Svensson, MD, Principal Investigator, Affiliation: Karolinska Institutet

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.

Clinical Details

Official title: Conservative Treatment of Acute Appendicitis in Children Pilot Trial

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

Primary outcome: Resolution of symptoms without significant complications

Secondary outcome:

Time in hospital

Time to resolution of symptoms

Abscess formation

Early complications

Pain

Eligibility

Minimum age: 5 Years. Maximum age: 15 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Astrid Lindgren ChildrenĀ“s Hospital, Stockholm 17176, Sweden
Additional Information

Starting date: February 2012
Last updated: October 15, 2012

Page last updated: August 23, 2015

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