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

• Status: Not yet recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Anti-Bacterial Agents

Criteria

Inclusion Criteria:

• Age ≥18 years

• Able to consent for the study

• Diagnosis of acute appendicitis confirmed by CT imaging

Exclusion Criteria:

• Appendicolith/fecalith on imaging

• Chronic or recurrent appendicitis

• Having received prior antibiotic treatment for other reasons within 5 days prior to study enrollment

• Hemodynamically 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)