Conservative Treatment of Acute Appendicitis in Children (CONSAPP Pilot)

October 15, 2012 updated by: Jan Svensson, Karolinska University Hospital

Conservative Treatment of Acute Appendicitis in Children Pilot Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • Astrid Lindgren Children´s Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Appendectomy
Standard surgical treatment, appendectomy
Procedure: Appendectomy
Standard surgical treatment, normally laparoscopic appendectomy
Other Names:
  • Laparoscopic appendectomy
  • Open 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.
Other Names:
  • Ciprofloxacin
  • Meropenem
  • Metronidazol
  • Flagyl®
  • Meronem®
  • Ciproxin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Investigators

  • Principal Investigator: Jan F Svensson, MD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

February 13, 2012

First Submitted That Met QC Criteria

April 4, 2012

First Posted (Estimate)

April 6, 2012

Study Record Updates

Last Update Posted (Estimate)

October 17, 2012

Last Update Submitted That Met QC Criteria

October 15, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA2011/4:8

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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