Is Interval Appendectomy Necessary?
Appendicitis is one of the most common surgical problems in children, with 20-35% of patients having perforated by the time they present to a doctor. In these cases, the patient is often treated non-surgically with antibiotics. Once a patient has improved, it is not known whether it is better to perform an interval appendectomy (IA) or to continue a watchful waiting approach. The purpose of this trial is to determine if expectant nonoperative management (watchful waiting) is not inferior compared to IA management after successful conservative treatment of appendiceal mass at admission.
Procedure: Conservative Management
Procedure: Operative Management
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Interval Appendectomy in Children, is it Really Necessary? A Randomized, Noninferiority Trial|
- Recurrent appendicitis for the conservative group [ Time Frame: During a year of follow-up ] [ Designated as safety issue: Yes ]
- Operative complications for the operative group [ Time Frame: During a year of follow-up ] [ Designated as safety issue: Yes ]
- Duration of hospital stay [ Time Frame: This is the patients' original hospital stay, and re-admission for interval appendectomy when applicable, an expected average of 5 days ] [ Designated as safety issue: No ]
|Study Start Date:||April 2013|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: 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.
|Procedure: Conservative Management|
Active Comparator: 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.
|Procedure: Operative Management|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01853683
|Children's Hospital of Eastern Ontario||Recruiting|
|Ottawa, Ontario, Canada, K1H 8L1|
|Contact: Ahmed Nasr firstname.lastname@example.org|
|Principal Investigator: Ahmed Nasr|
|Sub-Investigator: Juan Bass|
|Sub-Investigator: Marcos Bettolli|
|Principal Investigator:||Ahmed Nasr, MD||Children's Hospital of Eastern Ontario|