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

NCT05724628 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-03-26

No results posted yet for this study

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.

Conditions

  • Acute Appendicitis

Interventions

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

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Sneha Bhat · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2023-11-30
Completion
2023-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05724628 on ClinicalTrials.gov