A Pilot Randomized Trial of Non-operative Versus Operative Management of Acute Appendicitis in Vulnerable Patient Populations

NCT05724628 Phase 1 WITHDRAWN

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.

Details

Lead sponsor	University of Texas Southwestern Medical Center
Phase	Phase 1
Status	WITHDRAWN
Start date	2023-10
Completion	2023-11

Conditions

• Acute Appendicitis

Interventions

• Laparoscopic appendectomy
• Antibiotics (IV transitioned to oral)

Primary outcomes

• Feasibility of the intervention as measured by the proportion of enrolled participants retained in this study — 12 months post treatment
  Feasibility of the intervention is measured by the proportion of enrolled participants who are randomized and retained in this study
• Feasibility of the intervention as measured by the number of complications or adverse events — 12 months post treatment
  Feasibility of the intervention is measured by the number of complications or adverse events encountered by participants while enrolled in this study