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

The University of Texas System (UT)

Status and phase: Withdrawn; Phase 1

Conditions: Acute Appendicitis

Treatments: Drug: Antibiotics (IV transitioned to oral); Procedure: Laparoscopic appendectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05724628

STU-2021-0035

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Operative Arm

Experimental group

Description:

Operation (laparoscopic appendectomy) will be performed to remove appendix.

Treatment:

Procedure: Laparoscopic appendectomy

Non-Operative Arm

Experimental group

Description:

No operation will be performed, and instead, will receive intra-venous (IV) antibiotics, transitioned to by mouth (oral) antibiotics

Treatment:

Drug: Antibiotics (IV transitioned to oral)