We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov Menu

Antibiotic Treatment Alone for Acute Simple Appendicitis in Children

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: May 19, 2011
Last Update Posted: January 13, 2017
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.
Red Cross Hospital Beverwijk
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
St. Antonius Hospital
Information provided by (Responsible Party):
Ramon R. Gorter, VU University of Amsterdam
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
Intervention Model: Single Group Assignment
Masking: None (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 Ramon R. Gorter, VU University of Amsterdam:

Primary Outcome Measures:
  • Safety of initial antibiotic treatment strategy [ Time Frame: 0-12 months ]

    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 ]

    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
Study Completion Date: January 2017
Primary Completion Date: January 2017 (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


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:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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): NCT01356641

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
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
First Submitted: April 18, 2011
First Posted: May 19, 2011
Last Update Posted: January 13, 2017
Last Verified: January 2017

Keywords provided by Ramon R. Gorter, VU University of Amsterdam:
Antibiotic treatment
Non perforated appendicitis

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