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High failure rate
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To determine if non-operative management with antibiotics alone is a feasible treatment alternative for pediatric patients with uncomplicated acute appendicitis with an appendicolith identified on imaging.
This study is a prospective randomized clinical trial comparing non-operative management with antibiotics to urgent appendectomy in children (ages 7-17yrs) with acute appendicitis with the presence of an appendicolith. Enrolled participants were followed up to 1 year post-discharge to observe the rates of appendicitis recurrence as well as identify the number of patients with complicated appendicitis as determined by pathologic examination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-operative Management | Experimental | Non-operative management with antibiotics only Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic |
|
| Surgery | No Intervention | Usual care with urgent appendectomy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotics only (Zosyn then Augmentin) | Drug | Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Did Not Have an Appendectomy | Percentage of patients who were successfully managed nonoperatively with success defined as not undergoing appendectomy by one year after discharge | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complicated Appendicitis | Percent of patients found to have complicated appendicitis (gangrenous or perforated) on pathologic examination. | 1 year |
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Inclusion Criteria:
Age : 7-17 years
Abdominal pain </= 48hours prior to receiving antibiotics
White Blood Cell Count >5 but < 18
US or CT confirmed early appendicitis plus:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter C Minneci, MD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24951281 | Background | Minneci PC, Sulkowski JP, Nacion KM, Mahida JB, Cooper JN, Moss RL, Deans KJ. Feasibility of a nonoperative management strategy for uncomplicated acute appendicitis in children. J Am Coll Surg. 2014 Aug;219(2):272-9. doi: 10.1016/j.jamcollsurg.2014.02.031. Epub 2014 Apr 13. | |
| 27018085 | Result | Mahida JB, Lodwick DL, Nacion KM, Sulkowski JP, Leonhart KL, Cooper JN, Ambeba EJ, Deans KJ, Minneci PC. High failure rate of nonoperative management of acute appendicitis with an appendicolith in children. J Pediatr Surg. 2016 Jun;51(6):908-11. doi: 10.1016/j.jpedsurg.2016.02.056. Epub 2016 Mar 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-operative | Non-operative management with antibiotics alone Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic Antibiotics only (Zosyn then Augmentin): Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic |
| FG001 | Surgery | Usual care with urgent appendectomy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-operative | Non-operative management with antibiotics alone Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic Antibiotics only (Zosyn then Augmentin): Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants That Did Not Have an Appendectomy | Percentage of patients who were successfully managed nonoperatively with success defined as not undergoing appendectomy by one year after discharge | Posted | Count of Participants | Participants | 1 year |
|
Adverse events data were collected for the duration of the follow-ups which was up to 1 year post-discharge.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-operative | Non-operative management with antibiotics alone Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic Antibiotics only (Zosyn then Augmentin): Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Minneci | Nationwide Children's Hospital | 6147223066 | peter.minneci@nationwidechildrens.org |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| D005244 | Fecal Impaction |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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|
| BG001 |
| Surgery |
Usual care with urgent appendectomy |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Number of Participants With Complicated Appendicitis | Percent of patients found to have complicated appendicitis (gangrenous or perforated) on pathologic examination. | Posted | Count of Participants | Participants | 1 year |
|
|
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Surgery | Usual care with urgent appendectomy | 0 | 9 | 0 | 9 | 0 | 9 |
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| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D007415 | Intestinal Obstruction |