Clinical trial NCT05724628: Non-operative vs. Operative Management of Acute Appendicitis in Vulnerable Patient Populations
Official title: A Pilot Randomized Trial of Non-operative Versus Operative Management of Acute Appendicitis in Vulnerable Patient Populations
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Acute Appendicitis
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Feasibility of the intervention as measured by the proportion of enrolled participants retained in this study
timeFrame: 12 months post treatment
measure: Feasibility of the intervention as measured by the number of complications or adverse events
timeFrame: 12 months post treatment
Secondary outcomes:
measure: Feasibility of the intervention as measured by total length of hospital stay (Antibiotics Group)
timeFrame: the day of discharge (approx. 1-3 days post treatment)
measure: Feasibility of the intervention as measured by total length of hospital stay (Operative Group)
timeFrame: the day of discharge (approx. 0-2 days post treatment)
measure: Feasibility of the intervention as measured by the number of hospital readmissions or emergency room visits
timeFrame: 1-2 weeks post-discharge
measure: Feasibility of the intervention as measured by the number of hospital readmissions or emergency room visits
timeFrame: 6 weeks post-discharge
measure: Feasibility of the intervention as measured by QoL surveys
timeFrame: prior to discharge home (approx. 4-6 hours post treatment)
measure: Feasibility of the intervention as measured by QoL surveys
timeFrame: 1-2 weeks post-discharge
measure: Feasibility of the intervention as measured by QoL surveys
timeFrame: 6 weeks post-discharge
measure: Change in pain score from baseline as measured by visual analog pain scale at prior to discharge home (approx. 4-6 hours post treatment)
timeFrame: Baseline, prior to discharge home (approx. 4-6 hours post treatment)
measure: Change in pain score from baseline as measured by visual analog pain scale at 1-2 weeks post discharge
timeFrame: Baseline, 1-2 weeks post discharge
measure: Change in pain score from baseline as measured by visual analog pain scale at 6 weeks post discharge
timeFrame: Baseline, 6 weeks post discharge
measure: Change in cognitive function as measured by CAM assessment form at 1-2 weeks post discharge
timeFrame: Baseline, 1-2 weeks post discharge
measure: Change in cognitive function as measured by CAM assessment form at 6 weeks post discharge
timeFrame: Baseline, 6 weeks post discharge
measure: Feasibility of the intervention as measured by physical function using FRAIL scale
timeFrame: Baseline
measure: Feasibility of the intervention as measured by hospital costs for each enrolled participant (Antibiotics Group)
timeFrame: the day of discharge (approx. 1-3 days post treatment)
measure: Feasibility of the intervention as measured by hospital costs for each enrolled participant (Operative Group)
timeFrame: the day of discharge (approx. 0-2 days post treatment)
Other outcomes:
Locations:
Study officials:
affiliation: UT Southwestern Medical Center
name: Sneha Bhat
role: PRINCIPAL_INVESTIGATOR
References: