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Antibiotic Treatment Alone for Acute Simple Appendicitis in Children

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Red Cross Hospital Beverwijk
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
St. Antonius Hospital
Flevoziekenhuis
Information provided by (Responsible Party):
Ramon R. Gorter, VU University of Amsterdam
ClinicalTrials.gov Identifier:
NCT01356641
First received: April 18, 2011
Last updated: June 24, 2016
Last verified: June 2016
  Purpose
Appendectomy for acute appendicitis has recently been questioned as being the only correct treatment for appendicitis. Appendectomy has been reported to have significant early and late morbidity. This can be avoided with antibiotic treatment alone. Moreover, better quality of life and lower costs have been associated with antibiotic treatment alone. Five clinical trials in selected patients (males, older than 18 years) comparing appendectomy and antibiotic treatment alone as primary mode of treatment found that antibiotic treatment alone is safe and effective in 48-95% of the patients Conclusive evidence with regard to the efficacy of antibiotic treatment alone in children with proven acute appendicitis however is lacking. We propose a prospective cohort study to answer the following questions:

Condition Intervention
Appendicitis
Drug: Antibiotic treatment alone
Procedure: Appendectomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Antibiotic Treatment Alone for Acute Simple Appendicitis in Children; a Prospective Cohort Study Part of the Antibiotic Versus Primary Appendectomy in Children (APAC) Trial

Resource links provided by NLM:


Further study details as provided by VU University of Amsterdam:

Primary Outcome Measures:
  • Safety of initial antibiotic treatment strategy [ Time Frame: 0-12 months ] [ Designated as safety issue: Yes ]

    Occurrence of major complications, such as:

    A. Anaphylactic shock and other allergic reaction to antibiotics administered b. Recurrent appendicitis within 8 weeks c. Recurrent appendicitis within one year after discharge d. Development of perforated appendicitis e. Occurrence of major complaints after delayed appendectomy such as intra-abdominal abscess (IAA), stumpleakage, superficial site infection (SSI), anaesthesia related complications, secondary bowel obstruction (SBO), re-admission, need for re-intervention f. Re-admission g. Re-intervention other than delayed appendectomy



Secondary Outcome Measures:
  • Safety of the direct appendectomy treatment strategy [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]

    Major complications associated with appendectomy

    1. Stumpleakage
    2. Intra-abdominal abscess (IAA)
    3. Secondary bowel obstruction (SBO)
    4. Superficial site infection (SSI)
    5. Need for secondary operation
    6. Need for other re-intervention
    7. Re-admission
    8. Anaesthesia related complication
    9. Pneumonia


Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antibiotic treatment alone

Intravenous administration:

Amoxicillin/clavulanic acid 100/10 mg/kg 6-hourly Gentamicin 7mg/kg once daily

Oral administration of:

Amoxicillin/clavulanic acid 50/12.5 mg/kg/day (in three doses)

Drug: Antibiotic treatment alone
Amoxicillin/clavulanic acid 100/10 mg/kg 6-hourly Gentamicin 7 mg/kg once daily At least 48 hours intravenous administration, in total seven days of antibiotics Oral amoxicillin/clavulanic acid 50/12.5mg/kg
Active Comparator: Appendectomy
Routine appendectomy either laparoscopic or open depending on the surgeon's preference
Procedure: Appendectomy
Appendectomy either open or laparoscopic depending on the surgeon's preference

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 7-17 years
  2. Radiologically confirmed simple appendicitis, defined as:

    a. Clinical findings: i. Unwell, but not generally ill ii. Localized tenderness in the right iliac fossa region iii. Normal/hyperactive bowel sounds iv. No guarding v. No mass palpable b. Ultrasonography: i. Incompressible appendix with an outer diameter of ≥6 mm ii. Hyperaemia within the appendiceal wall iii. Without fecalith iv. Infiltration of surrounding fat v. No signs of perforation vi. No signs of intra abdominal abscess/phlegmon

Exclusion criteria:

  1. Patients with severe general illness at time of presentation:

    1. Generalized peritonitis defined as:

      Diffuse inflammation of the peritoneum with clinical signs consisting of increasing abdominal pain, generalized tenderness, diffuse abdominal rigidity, sinus tachycardia, signs of paralytic ileus

    2. Severe sepsis or septic shock, as defined by the international paediatric sepsis consensus conference [39]. See attachment 1.
    3. Signs of complex appendicitis
  2. Children with a fecalith on ultrasonography.
  3. Patients with serious associated conditions or malformations such as:

    1. Congenital or acquired cardiac or pulmonary disease with significant hemodynamic consequences
    2. Immunodeficiency
    3. Malignancy
    4. Homozygous sickle cell disease
    5. Metabolic disorders
  4. Patient with documented type 1 allergy to the antibiotics used
  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: NCT01356641

Locations
Netherlands
Flevoziekenhuis
Almere, Netherlands
Academic medical center of Amsterdam
Amsterdam, Netherlands
VU University medical center
Amsterdam, Netherlands
Red Cross Hospital
Beverwijk, Netherlands
Sponsors and Collaborators
Ramon R. Gorter
Red Cross Hospital Beverwijk
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
St. Antonius Hospital
Flevoziekenhuis
Investigators
Principal Investigator: Ramon R Gorter, MD VU University Medical Center
Study Chair: Hugo A Heij, MD, PhD VU University Medical Center
  More Information

Responsible Party: Ramon R. Gorter, MD, PhD candidate, VU University of Amsterdam
ClinicalTrials.gov Identifier: NCT01356641     History of Changes
Other Study ID Numbers: KCA2011/APAC 
Study First Received: April 18, 2011
Last Updated: June 24, 2016
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by VU University of Amsterdam:
Antibiotic treatment
Non perforated appendicitis
Children

Additional relevant MeSH terms:
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Anti-Bacterial Agents
Clavulanic Acids
Clavulanic Acid
Amoxicillin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors

ClinicalTrials.gov processed this record on December 07, 2016