Antibiotic Treatment Alone for Acute Simple Appendicitis in Children
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ClinicalTrials.gov Identifier: NCT01356641 |
Recruitment Status :
Completed
First Posted : May 19, 2011
Last Update Posted : January 13, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Appendicitis | Drug: Antibiotic treatment alone Procedure: Appendectomy | Not Applicable |

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 |

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
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Procedure: Appendectomy
Appendectomy either open or laparoscopic depending on the surgeon's preference |
- 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
- Safety of the direct appendectomy treatment strategy [ Time Frame: 0-12 months ]
Major complications associated with appendectomy
- Stumpleakage
- Intra-abdominal abscess (IAA)
- Secondary bowel obstruction (SBO)
- Superficial site infection (SSI)
- Need for secondary operation
- Need for other re-intervention
- Re-admission
- Anaesthesia related complication
- Pneumonia

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Ages Eligible for Study: | 7 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 7-17 years
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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:
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Patients with severe general illness at time of presentation:
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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
- Severe sepsis or septic shock, as defined by the international paediatric sepsis consensus conference [39]. See attachment 1.
- Signs of complex appendicitis
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- Children with a fecalith on ultrasonography.
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Patients with serious associated conditions or malformations such as:
- Congenital or acquired cardiac or pulmonary disease with significant hemodynamic consequences
- Immunodeficiency
- Malignancy
- Homozygous sickle cell disease
- Metabolic disorders
- Patient with documented type 1 allergy to the antibiotics used

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
Netherlands | |
Flevoziekenhuis | |
Almere, Netherlands | |
Academic medical center of Amsterdam | |
Amsterdam, Netherlands | |
VU University medical center | |
Amsterdam, Netherlands | |
Red Cross Hospital | |
Beverwijk, Netherlands |
Principal Investigator: | Ramon R Gorter, MD | VU University Medical Center | |
Study Chair: | Hugo A Heij, MD, PhD | VU University Medical Center |
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 Key Record Dates |
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 |