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Non-operative Management for Appendicitis in Children (APRES)

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ClinicalTrials.gov Identifier: NCT02795793
Recruitment Status : Unknown
Verified September 2018 by Dr Susan Adams, Sydney Children's Hospitals Network.
Recruitment status was:  Recruiting
First Posted : June 10, 2016
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Susan Adams, Sydney Children's Hospitals Network

Brief Summary:
This study is designed to determine the safety and efficacy of non-operative antibiotic management of clinically diagnosed acute uncomplicated appendicitis in children. Enrolled patients will be randomised and an allocation ratio of 1:1 will be made via weighted minimisation, where half of the patients will receive non-operative management with intravenous Piperacillin with Tazobactam, while the other half will have an appendicectomy.

Condition or disease Intervention/treatment Phase
Acute Focal Appendicitis Appendicitis Drug: Non-operative management group (NOM) Procedure: Appendectomy group (Operative management, OM) Not Applicable

Detailed Description:

Appendicectomy for acute appendicitis is one of the most commonly performed paediatric emergency operations in Australia. This standard treatment of acute uncomplicated appendicitis (AUA) has remained largely unchallenged since its introduction in the late nineteenth century, under the assumption that AUA progresses to perforation and thus complications should an operation be withheld. However, appendicectomy via laparoscopic or open approach is not without its risks.

Non-operative management (NOM) with antibiotics has been increasingly accepted as mainstay therapy for many intra-abdominal infections. In fact, children with appendicitis complicated by perforation, abscess or phlegmon formation are often preferentially treated non-operatively with antibiotic therapy, with or without percutaneous drainage. Systematic reviews and meta-analyses have demonstrated that antibiotics are a safe and effective treatment for AUA in adults and there is growing evidence that NOM is safe and effective in children.

Primary objectives:

To determine the safety and efficacy of non-operative antibiotic management of clinically diagnosed likely AUA in children.

Secondary objectives:

  1. To compare the safety and efficacy of NOM of clinically diagnosed likely AUA with operative management (OM) in children.
  2. To assess the cost-effectiveness of NOM of clinically diagnosed likely AUA against OM in children.
  3. To assess the feasibility and acceptability of NOM of appendicitis in children.

This study will enrol 226 patients, age 5-16 years, with acute uncomplicated appendicitis at two tertiary children's hospitals. Allocation ratio of 1:1 will be made via weighted minimisation using the following criteria: age (5-8 years or 9-16 years), gender (male or female), and duration of symptoms (<48 or >48 hours).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomised Controlled Non-inferiority Study to Evaluate the Effectiveness and Safety (APRES) of Non-operative Management in Children With Acute Uncomplicated Appendicitis
Study Start Date : May 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Arm Intervention/treatment
Experimental: Non-operative management group (NOM)
Children in the NOM group will receive intravenous Piperacillin with Tazobactam (Tazocin) 100mg/kg/dose every 8 hours for at least 24 hours, and they will be observed and reassessed within 24 hours after randomisation. A further 24 hours of intravenous Piperacillin with Tazobactam therapy will be offered to children in invariable condition. A clinical decision will be made by the attending surgeon to offer OM if a patient's condition deteriorates at any time, or if a patient has failed to improve after 48 hours of intravenous antibiotic therapy. Once the patient is clinically improving and tolerating oral intake, the antibiotic regimen will be changed to oral Amoxicillin plus Clavulanic acid (Augmentin) 22.5mg/kg/dose twice per day to complete a total seven day course of antibiotics. Oral Ciprofloxacin 15mg/kg/dose twice daily and oral Metronidazole 10mg/kg/dose twice daily will be offered to children who are known to have an intolerance or allergy to Amoxicillin or Clavulanic acid.
Drug: Non-operative management group (NOM)
With intravenous Piperacillin with Tazobactam (Tazocin)

Active Comparator: Appendectomy group (Operative management, OM)
Children allocated to OM may receive preoperative antibiotic prophylaxis as clinically indicated. Appendicectomy will be performed laparoscopically, or via open surgery according to the surgeon's standard practice. Postoperative antibiotic treatment will be determined on the basis of intraoperative findings in accordance with the institutional practice. The appendix specimen will be examined by a paediatric pathologist, and the formal histopathology report will be recorded.
Procedure: Appendectomy group (Operative management, OM)



Primary Outcome Measures :
  1. Unplanned or unnecessary operation(s) and complications [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Unplanned or unnecessary operation, or complications [ Time Frame: 6 months ]
  2. Length of primary hospital stay [ Time Frame: 72 hours ]
    Time of randomisation to discharge

  3. Treatment-related complications [ Time Frame: 12 months ]
  4. Redamission and Emergency Department presentation [ Time Frame: 12 months ]
  5. Cost of treatment in Australian Dollars (AUD) [ Time Frame: 12 months ]
  6. Return to school from time of randomisation [ Time Frame: 30 days ]
  7. Return to normal activities from time of randomisation [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 5 and 15 years;
  2. Clinical diagnosis by at least one paediatric surgeon (or duty surgical registrar) of acute uncomplicated appendicitis based on with a combination of clinical, laboratory and/or imaging findings; that before the study would have led to the decision to recommend been subjected to an appendicectomy.

Exclusion Criteria: if one or more of the following is assessed to be present

  1. Suspicion of perforated appendicitis on the basis of generalised peritonitis and/or imaging studyA diagnosis of perforated or complicated appendicitis (e.g. peritonitis, appendiceal mass) is made on the basis of clinical, laboratory and/or imaging findings;
  2. Previous non-operative treatment of acute appendicitis;
  3. Age younger than 5 years or older than 16 years;
  4. Known intolerance or allergy to Piperacillin with Tazobactam;
  5. Known history of inflammatory bowel disease, or other chronic abdominal pain syndrome;
  6. Known concurrent significant illness;
  7. Unable to obtain informed consent from parents or guardian;
  8. Known to have a cognitive impairment, an intellectual disability or a mental illness that would impair participation.

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): NCT02795793


Contacts
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Contact: Susan Adams, MBBS 61 02 9382 1776 susan.adams@unsw.edu.au
Contact: Jonathan Karpelowsky, MBBCh 61 02 9845 3349 jonathan.karpelowsky@health.nsw.gov.au

Locations
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Australia, New South Wales
Sydney Children's Hospital Recruiting
Randwick, New South Wales, Australia, 2031
Contact: Susan Adams, MBBS         
Principal Investigator: Susan Adams, MBBS         
The Children's Hospital at Westmead Not yet recruiting
Westmead, New South Wales, Australia, 2145
Contact: Jonathon Karpewlosky, MBBCh         
Principal Investigator: Jonathon Karpelowsky, MBBCh         
Sponsors and Collaborators
Sydney Children's Hospitals Network
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Susan Adams, Sydney Children's Hospitals Network
ClinicalTrials.gov Identifier: NCT02795793    
Other Study ID Numbers: HERC/15/SCHN/266
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Keywords provided by Dr Susan Adams, Sydney Children's Hospitals Network:
appendicitis
non-operative management
children
pediatric
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases