Antibiotic Treatment Alone for Acute Simple Appendicitis in Children

NCT01356641 | Completed DMC

• 1 other identifier: KCA2011/APAC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

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:

Conditions

Appendicitis

Keywords

Antibiotic treatment; Non perforated appendicitis; Children

Outcome Measures

Primary Outcomes (1)

• Safety of initial antibiotic treatment strategy

  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

  0-12 months

Secondary Outcomes (1)

• Safety of the direct appendectomy treatment strategy

  0-12 months

Study Arms (2)

Antibiotic treatment alone

EXPERIMENTAL

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

Appendectomy

ACTIVE COMPARATOR

Routine appendectomy either laparoscopic or open depending on the surgeon's preference

Procedure: Appendectomy

Interventions

Antibiotic treatment alone DRUG

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

Antibiotic treatment alone

Appendectomy PROCEDURE

Appendectomy either open or laparoscopic depending on the surgeon's preference

Appendectomy

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 7-17 years
• 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

You may not qualify if:

• Patients with severe general illness at time of presentation:
• 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
• Children with a fecalith on ultrasonography.
• 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

Sponsors & Collaborators

• Ramon R. Gorter: lead
• Red Cross Hospital Beverwijk: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• St. Antonius Hospital: collaborator
• Flevoziekenhuis: collaborator

Study Sites (4)

Flevoziekenhuis

Almere Stad, Netherlands

Location

Academic medical center of Amsterdam

Amsterdam, Netherlands

Location

VU University medical center

Amsterdam, Netherlands

Location

Red Cross Hospital

Beverwijk, Netherlands

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Appendectomy

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ramon R Gorter, MD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

• Hugo A Heij, MD, PhD

  Amsterdam UMC, location VUmc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD candidate

Study Record Dates

• First Submitted: April 18, 2011
• First Posted: May 19, 2011
• Study Start: September 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 13, 2017

Record last verified: 2017-01

Locations

NL (4)