Conservative Treatment of Acute Appendicitis in Children (CONSAPP Pilot)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jan Svensson, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01572558
First received: February 13, 2012
Last updated: October 15, 2012
Last verified: October 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Karolinska University Hospital:

Primary Outcome Measures:
  • Resolution of symptoms without significant complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    Number of days as inpatients after initiation of allocated treatment, ea. after randomization.

  • Time to resolution of symptoms [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    As noted either in hospital or during follow up.

  • Early complications [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    Wound infections, wound dehiscence, diarrhea etc.

  • Pain [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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:
  • Appendectomy
  • 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

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jan Svensson, Principal investigator, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01572558     History of Changes
Other Study ID Numbers: EA2011/4:8
Study First Received: February 13, 2012
Last Updated: October 15, 2012
Health Authority: Sweden: Regional Ethical Review Board

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

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Meropenem
Antibiotics, Antitubercular
Ciprofloxacin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014