Conservative Treatment of Acute Appendicitis in Children (CONSAPP Pilot)

Karolinska University Hospital

Status: Completed

Conditions: Appendicitis; Child

Treatments: Drug: Conservative, non-surgical treatment; Procedure: Appendectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01572558

EA2011/4:8

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 5 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Appendectomy

Active Comparator group

Description:

Standard surgical treatment, appendectomy

Treatment:

Procedure: Appendectomy

Conservative, non-surgical treatment

Experimental group

Description:

Non-operative treatment with intravenous and oral antibiotics

Treatment:

Drug: Conservative, non-surgical treatment