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Not feasible to complete trial due to low enrollment rate. Enrollment terminated and inadequately powered to achieve statistical significance on primary and secondary study outcomes.
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The purpose of this study is to demonstrate the safety, efficacy, and feasibility of short-course post-operative antibiotic treatment for simple and complicated appendicitis
This is a single center, randomized controlled trial to determine if decreasing the amount of antibiotics after appendicitis surgery can decrease the risk of adverse effects associated with antibiotics while at the same time ensuring participant safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restricted Post-Operative Antibiotics Group | Experimental | Participants undergoing standard of care (SOC) with simple appendicitis will not receive post-operative antibiotics. Participants undergoing standard of care with complicated (gangrenous or perforated) appendicitis will receive up to 24 hours of SOC post-operative antibiotics. |
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| Liberal Post-Operative Antibiotics Group | Active Comparator | Participants undergoing standard of care with simple appendicitis will receive 24 hours of post-operative SOC antibiotics Participants undergoing standard of care with complicated (gangrenous or perforated) appendicitis will receive 4 days of post-operative SOC antibiotics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiple standard of care antibiotics for appendicitis, at physicians' discretion | Drug | Standard of Care Antibiotic use will be restricted to none or up to 24 hours of post-operative antibiotics. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Infectious/Antibiotic Complications | Infectious/antibiotic complication requiring antibiotic treatment only, Emergency Department visit, hospital readmission, percutaneous drainage, and operative intervention as assessed by treating physician. | Up to 30 days after appendicitis surgery |
| Number of participant deaths | Up to 30 days after appendicitis surgery | Up to 30 days after appendicitis surgery |
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Inclusion Criteria:
Age ≥ 18 years
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucy Kornblith, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuckerberg San Francisco General Hospital | San Francisco | California | 94110 | United States |
Patient data will be shared with Denver health and combined with data from other independent sites for final analysis
Beginning 9 months and ending 36 months following article publication
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose
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| Multiple standard of care antibiotics for appendicitis, at physicians' discretion | Drug | Standard of Care Antibiotic use will be permitted for 24 hours or up to 4 days of post-operative antibiotics. |
|
| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
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