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Conservative Treatment of Acute Appendicitis in Children (CONSAPP Pilot)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01572558
First Posted: April 6, 2012
Last Update Posted: October 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jan Svensson, Karolinska University Hospital
  Purpose
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.

Condition Intervention
Appendicitis Child Procedure: Appendectomy Drug: Conservative, non-surgical treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Conservative Treatment of Acute Appendicitis in Children Pilot Trial

Resource links provided by NLM:


Further study details as provided by Jan Svensson, Karolinska University Hospital:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • Time in hospital [ Time Frame: 7 days ]
    Number of days as inpatients after initiation of allocated treatment, ea. after randomization.

  • 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.

  • Abscess formation [ Time Frame: 7 days ]
    As noted either in hospital or during follow up.

  • Early complications [ Time Frame: 7 days ]
    Wound infections, wound dehiscence, diarrhea etc.

  • Pain [ Time Frame: 48 hours ]
    Measured after 12, 24 and 48 hours with the 0-10 Visual Analoge Scale.


Enrollment: 51
Study Start Date: February 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Appendectomy
Standard surgical treatment, appendectomy
Procedure: Appendectomy
Standard surgical treatment, normally laparoscopic appendectomy
Other Names:
  • Open appendectomy
  • Laparoscopic 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:
  • Meronem®
  • Meropenem
  • Flagyl®
  • Metronidazol
  • Ciproxin®
  • Ciprofloxacin

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572558


Locations
Sweden
Astrid Lindgren Children´s Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska University Hospital
Investigators
Principal Investigator: Jan F Svensson, MD Karolinska Institutet
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jan Svensson, Principal investigator, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01572558     History of Changes
Other Study ID Numbers: EA2011/4:8
First Submitted: February 13, 2012
First Posted: April 6, 2012
Last Update Posted: October 17, 2012
Last Verified: October 2012

Keywords provided by Jan Svensson, Karolinska University Hospital:
Appendectomy
Nonsurgical treatment with antibiotics

Additional relevant MeSH terms:
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Anti-Bacterial Agents
Ciprofloxacin
Meropenem
Antibiotics, Antitubercular
Metronidazole
Anti-Infective Agents
Antitubercular Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antiprotozoal Agents
Antiparasitic Agents