The Management of Perforated Acute Appendicitis in Adult and Pediatric Populations
NCT ID: NCT04253899
Last Updated: 2023-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2020-02-20
2023-11-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard pediatric group:
patients ≤17 yo with acute perforated appendicitis and interval appendectomy (n=25)
Appendectomy
Interval Appendectomy
Experimental pediatric group:
patients ≤17 yo with acute perforated appendicitis abscess and observation (n=25)
Observation
observation and follow up
Standard adult group:
patients ≥18 yo with acute perforated appendicitis and interval appendectomy (n=25)
Appendectomy
Interval Appendectomy
Experimental adult group:
Patients ≥18 yo with acute perforated appendicitis and observation (n=25)
Observation
observation and follow up
Interventions
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Appendectomy
Interval Appendectomy
Observation
observation and follow up
Eligibility Criteria
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Inclusion Criteria
* Clinical and radiological diagnosis by contrast CT scan of acute perforated appendicitis.
* Formal consent for the present study must be signed by the patient or his/her parents
* Patients with initial presentation of a phlegmon (abscess in evolution)
Exclusion Criteria
* Presentation with initially non-perforated appendicitis but found perforation at surgery
* Patient with septic shock
* Patients who had previous appendectomy
* Current treatment of malignancy
* Immunocompromised patients
* Positive pregnancy test
* No consent for the study
ALL
No
Sponsors
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Marshall University
OTHER
Responsible Party
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Juan Sanabria
Professor of Surgery
Principal Investigators
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Juan Sanabria, MD MSc FACS
Role: PRINCIPAL_INVESTIGATOR
Marshall University School of Medicine
Locations
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Marshall University School of Medicine
Huntington, West Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1504002-3
Identifier Type: -
Identifier Source: org_study_id
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