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Patients admitted at Marshall Health - Cabell Huntington Hospital with the diagnosis of acute perforated appendicitis or appendicular abscess larger than 3cm will be admitted and treated with percutaneous drainage and the IV antibiotics for 3 days. If the patient becomes afebrile and has a normal WBC, the patient will stay in the hospital for a single day with oral antibiotics and then will be discharged to continue oral antibiotics for seven more days. If the patient is febrile or has elevated WBC either after the 3 days of IV antibiotics or the single day of oral antibiotics, the patient will complete a course of IV antibiotics for a total of seven days. If still febrile, the patient will undergo further assessment.
A follow up will be conducted ~10 days after discharge from the hospital to determine if the patient is still symptomatic or asymptomatic. Asymptomatic patients will be followed up every month for 3 months, while symptomatic patients will be treated as needed. After 12 weeks, subjects will be randomized to interval appendectomy vs observation. Follow-ups will occur every 3 months for 12 months, when the study will be concluded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard pediatric group: | Active Comparator | patients ≤17 yo with acute perforated appendicitis and interval appendectomy (n=25) |
|
| Experimental pediatric group: | Experimental | patients ≤17 yo with acute perforated appendicitis abscess and observation (n=25) |
|
| Standard adult group: | Active Comparator | patients ≥18 yo with acute perforated appendicitis and interval appendectomy (n=25) |
|
| Experimental adult group: | Experimental | Patients ≥18 yo with acute perforated appendicitis and observation (n=25) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Appendectomy | Procedure | Interval Appendectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine rate and severity of complications after interval appendectomy | 12 months | |
| Determine the incidence and rate of appendectomies (in the observation arm) during the first year of diagnosis | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the rate of complete response after percutaneous drainage and antibiotic therapy | 12 months | |
| Determine the mean surgical value (quality/cost) for each group | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Sanabria, MD MSc FACS | Contact | 216 647 8399 | sanabriaj@marshall.edu | |
| Michael Abdelmasseh, MD | Contact | abdelmasseh@marshall.edu |
| Name | Affiliation | Role |
|---|---|---|
| Juan Sanabria, MD MSc FACS | Marshall University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marshall University School of Medicine | Recruiting | Huntington | West Virginia | 25701 | United States |
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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 |
|---|---|
| D001062 | Appendectomy |
| D019370 | Observation |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| Observation | Other | observation and follow up |
|
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |