Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
5 participants
INTERVENTIONAL
2013-04-30
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conservative Management
Children randomized to conservative management will be seen in the clinic 6-10 weeks after discharge and phoned to follow up every 3 month for a total follow-up of a year. Family will be instructed to come back to the hospital or call the treating physician if the child develops any abdominal pain or fever.
Conservative Management
Operative Management
Children randomized to IA will be scheduled for an interval appendectomy 6-10 weeks after discharge, and will be seen in the clinic 6-8 weeks following the interval appendectomy and phoned for follow-up every 3 month for a total of one year.
Operative Management
Interventions
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Conservative Management
Operative Management
Eligibility Criteria
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Inclusion Criteria
* Perforated appendicitis where the treating physician chooses to follow the conservative approach rather than performing an immediate appendectomy
Exclusion Criteria
* The need for laparotomy/laparoscopy for another reason
* Perforated appendicitis with diffuse abdominal fluid on imaging associated with a clinical picture of severe sepsis
* Another medical condition that may affect the decision to operate e.g., inflammatory bowel disease
* A comorbidity or chronic illness that contraindicates the watchful waiting approach, e.g, diabetes or cardiac problems
18 Years
ALL
No
Sponsors
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Children's Hospital of Eastern Ontario
OTHER
Responsible Party
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Ahmed Nasr
Principal Investigator
Principal Investigators
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Ahmed Nasr, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Eastern Ontario
Locations
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Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Countries
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Other Identifiers
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13/02E
Identifier Type: -
Identifier Source: org_study_id