A Pilot Randomized Trial of Non-operative Versus Operative Management of Acute Appendicitis in Vulnerable Patient Populations
Overview
- Phase
- Phase 1
- Intervention
- Laparoscopic appendectomy
- Conditions
- Acute Appendicitis
- Sponsor
- University of Texas Southwestern Medical Center
- Primary Endpoint
- Feasibility of the intervention as measured by the proportion of enrolled participants retained in this study
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Sneha Bhat
ASSISTANT PROFESSOR - Surgery
University of Texas Southwestern Medical Center
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 years
- •Able to consent for the study
- •Diagnosis of acute appendicitis confirmed by CT imaging
Exclusion Criteria
- •Appendicolith/fecalith on imaging
- •Chronic or recurrent appendicitis
- •Having received prior antibiotic treatment for other reasons within 5 days prior to study enrollment
- •Hemodynamically abnormal (SBP\<90 mmHg, Heart Rate (HR) \>120, mmHg, Partial Pressure of Oxygen in Arterial Blood (PaO2\<60), or potential of Hydrogen (pH\<7.3)).
- •Inability to tolerate general anesthesia (determined by surgery and anesthesiology teams)
Arms & Interventions
Operative Arm
Operation (laparoscopic appendectomy) will be performed to remove appendix.
Intervention: Laparoscopic appendectomy
Non-Operative Arm
No operation will be performed, and instead, will receive intra-venous (IV) antibiotics, transitioned to by mouth (oral) antibiotics
Intervention: Antibiotics (IV transitioned to oral)
Outcomes
Primary Outcomes
Feasibility of the intervention as measured by the proportion of enrolled participants retained in this study
Time Frame: 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
Time Frame: 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
Secondary Outcomes
- Feasibility of the intervention as measured by QoL surveys(6 weeks post-discharge)
- Change in pain score from baseline as measured by visual analog pain scale at 6 weeks post discharge(Baseline, 6 weeks post discharge)
- Feasibility of the intervention as measured by hospital costs for each enrolled participant (Antibiotics Group)(the day of discharge (approx. 1-3 days post treatment))
- Change in pain score from baseline as measured by visual analog pain scale at prior to discharge home (approx. 4-6 hours post treatment)(Baseline, prior to discharge home (approx. 4-6 hours post treatment))
- Change in cognitive function as measured by CAM assessment form at 1-2 weeks post discharge(Baseline, 1-2 weeks post discharge)
- Feasibility of the intervention as measured by total length of hospital stay (Operative Group)(the day of discharge (approx. 0-2 days post treatment))
- Feasibility of the intervention as measured by the number of hospital readmissions or emergency room visits(6 weeks post-discharge)
- Change in pain score from baseline as measured by visual analog pain scale at 1-2 weeks post discharge(Baseline, 1-2 weeks post discharge)
- Feasibility of the intervention as measured by hospital costs for each enrolled participant (Operative Group)(the day of discharge (approx. 0-2 days post treatment))
- Feasibility of the intervention as measured by total length of hospital stay (Antibiotics Group)(the day of discharge (approx. 1-3 days post treatment))
- Change in cognitive function as measured by CAM assessment form at 6 weeks post discharge(Baseline, 6 weeks post discharge)
- Feasibility of the intervention as measured by physical function using FRAIL scale(Baseline)