NCT05724628

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

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Acute Appendicitis

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic appendectomy	Subjects will receive surgery (using 3 port Laparoscopic appendectomy) to remove appendix
DRUG	Antibiotics (IV transitioned to oral)	Subjects will be admitted to the hospital for antibiotic treatment, initially with IV antibiotics and then transitioned to by mouth (PO) antibiotics for the rest of the course. Drugs used would be anything from: zosyn, ciprofloxacin or ceftriaxone and flagyl, augmentin

Timeline

• Start date: 2023-10-01
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2023-02-13
• Last updated: 2024-03-26