drugset / Trial / NCT05724628

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

NCT05724628 ↗

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-10
Primary completion
2023-11
Completion
2023-11

Outcome

Outcome not reported

Stopped: “Project did not receive final IRB approvals. PI decided to withdrawn research study.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Augmentin Unknown — Intravenous
Subject Ceftriaxone Other / unclassified — Intravenous
Subject Ciprofloxacin Small molecule — Intravenous
Subject Metronidazole Small molecule — Intravenous
Subject zosyn Unknown — Intravenous

Indications