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

NCT ID: NCT05724628

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2023-11-30

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.

Conditions

Acute Appendicitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Operative Arm

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

Group Type: EXPERIMENTAL

Laparoscopic appendectomy

Intervention Type: PROCEDURE

Subjects will receive surgery (using 3 port Laparoscopic appendectomy) to remove appendix

Non-Operative Arm

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

Group Type: EXPERIMENTAL

Antibiotics (IV transitioned to oral)

Intervention Type: DRUG

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

Interventions

Laparoscopic appendectomy

Subjects will receive surgery (using 3 port Laparoscopic appendectomy) to remove appendix

Intervention Type: PROCEDURE

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

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sneha Bhat

ASSISTANT PROFESSOR - Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sneha Bhat

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Other Identifiers

STU-2021-0035

Identifier Type: -

Identifier Source: org_study_id