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Not Yet Recruiting NCT05724628

Non-operative vs. Operative Management of Acute Appendicitis in Vulnerable Patient Populations

Conditions: Acute Appendicitis

Sex: All
Ages: 18 Years – N/A
Phase: PHASE1
Enrollment: 60
Sponsor: University of Texas Southwestern Medical Center

Summary

The overall project goal is to conduct a pilot randomized clinical trial of operative (laparoscopic appendectomy) vs nonoperative (antibiotic) management of uncomplicated acute appendicitis for vulnerable populations. Specifically, the elderly, non-English speakers, and those with economic vulnerability (low socioeconomic status and/or manual labor jobs without a non-weight lifting aspect), are three vulnerable population subsets identified. This pilot trial will provide critical preliminary data for planning and conducting a larger multi-site randomized trial.

Eligibility Criteria

Inclusion Criteria:Age ≥18 yearsAble to consent for the studyDiagnosis of acute appendicitis confirmed by CT imagingExclusion Criteria:Appendicolith/fecalith on imagingChronic or recurrent appendicitisHaving received prior antibiotic treatment for other reasons within 5 days prior to study enrollmentHemodynamically abnormal (SBP<90 mmHg, Heart Rate (HR) >120, mmHg, Partial Pressure of Oxygen in Arterial Blood (PaO2<60), or potential of Hydrogen (pH<7.3)).Inability to tolerate general anesthesia (determined by surgery and anesthesiology teams)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05724628). StuddyBuddy aggregates publicly available trial information.