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Low recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservative Management | Experimental | 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. |
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| Operative Management | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conservative Management | Procedure |
| ||
| Operative Management |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent appendicitis for the conservative group | During a year of follow-up | |
| Operative complications for the operative group | During a year of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of hospital stay | This is the patients' original hospital stay, and re-admission for interval appendectomy when applicable, an expected average of 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Nasr, MD | Children's Hospital of Eastern Ontario | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Procedure |
|
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |