Antibiotic Treatment Alone for Acute Simple Appendicitis in Children

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Appendicitis	Drug: Antibiotic treatment alone; Procedure: Appendectomy	Not Applicable

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	50 participants
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
Study Start Date :	September 2012
Actual Primary Completion Date :	January 2017
Actual Study Completion Date :	January 2017

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. 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

Eligibility Criteria

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Ages Eligible for Study:	7 Years to 17 Years (Child)
Sexes Eligible for Study:	All
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

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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

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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 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; Children

Additional relevant MeSH terms:

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