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

Status: Withdrawn
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years

• Able to consent for the study

• Diagnosis of acute appendicitis confirmed by CT imaging

Time Frame
Start Date: 2023-10
Completion Date: 2023-11
Treatments
Experimental: Operative Arm
Operation (laparoscopic appendectomy) will be performed to remove appendix.
Experimental: Non-Operative Arm
No operation will be performed, and instead, will receive intra-venous (IV) antibiotics, transitioned to by mouth (oral) antibiotics
Sponsors
Leads: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov