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

Acute Appendicitis Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

The study would involve consented subjects, once confirmed eligible to proceed after screening, will be randomly assigned to two arms: - Group 1 - Operative Group - Operation will be performed to remove appendix. - Group 2 - Non-operative group - No operation will be performed, and instead the subject will receive intra-venous (IV) antibiotics, transitioned to by mouth (oral) antibiotics, for treatment of appendicitis. Aside from the routine hospital care, participants will be asked to fill out a survey for cognitive function (CAM Assessment Form), pain (Visual Analog Scale), and quality of life at the start and end of participant's hospital stay, 1-2 weeks after discharge, and again at 6 weeks after discharge from the initial hospital visit. Participants will also be asked to participate in a qualitative interview, either by virtual visit, site visit, or phone call, at 1-2 weeks and again at about 6 weeks after discharge from the hospital. Each interview will be approximately 20-30 minutes of the participant's time. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05724628
Study type Interventional
Source University of Texas Southwestern Medical Center
Contact
Status Withdrawn
Phase Phase 1
Start date October 2023
Completion date November 2023
View Details
See also
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