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

A Pilot Randomized Trial of Non-operative Versus Operative Management of Acute Appendicitis in Vulnerable Patient Populations

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.

Study Overview

• Status: Withdrawn
• Conditions: Acute Appendicitis
• Intervention / Treatment: Procedure: Laparoscopic appendectomy; Drug: Antibiotics (IV transitioned to oral)

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.

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ana Garzon; Phone Number: 469/571-0840; Email: Ana.Garzon@UTSouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Operative Arm; Operation (laparoscopic appendectomy) will be performed to remove appendix.	Procedure: Laparoscopic appendectomy; Subjects will receive surgery (using 3 port Laparoscopic appendectomy) to remove appendix
Experimental: Non-Operative Arm; No operation will be performed, and instead, will receive intra-venous (IV) antibiotics, transitioned to by mouth (oral) antibiotics	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the intervention as measured by the proportion of enrolled participants retained in this study	Feasibility of the intervention is measured by the proportion of enrolled participants who are randomized and retained in this study	12 months post treatment
Feasibility of the intervention as measured by the number of complications or adverse events	Feasibility of the intervention is measured by the number of complications or adverse events encountered by participants while enrolled in this study	12 months post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the intervention as measured by total length of hospital stay (Antibiotics Group)	Feasibility of the intervention is measured by total number of days in inpatient hospital stay for the IV antibiotics group post treatment	the day of discharge (approx. 1-3 days post treatment)
Feasibility of the intervention as measured by total length of hospital stay (Operative Group)	Feasibility of the intervention is measured by total number of days in inpatient hospital stay for the Operative group post laparoscopic appendectomy	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	Feasibility of the intervention is measured by the count of the number of hospital readmissions or emergency room visits by the participants at 1-2 weeks post-discharge	1-2 weeks post-discharge
Feasibility of the intervention as measured by the number of hospital readmissions or emergency room visits	Feasibility of the intervention is measured by the count of the number of hospital readmissions or emergency room visits by the participants at 6 weeks post-discharge	6 weeks post-discharge
Feasibility of the intervention as measured by QoL surveys	Feasibility of the intervention is measured by administering Quality of Life (QoL) surveys using Quality of Recovery-40 questionnaire. This is a self-rated questionnaire for early postoperative quality of recovery and health status of patients. Possible scores range from 1 to 5, where higher scores indicate better quality of life (i.e., 1 = very poor and 5 = excellent)	prior to discharge home (approx. 4-6 hours post treatment)
Feasibility of the intervention as measured by QoL surveys	Feasibility of the intervention is measured by administering Quality of Life (QoL) surveys using Quality of Recovery-40 questionnaire. This is a self-rated questionnaire for early postoperative quality of recovery and health status of patients. Possible scores range from 1 to 5, where higher scores indicate better quality of life (i.e., 1 = very poor and 5 = excellent)	1-2 weeks post-discharge
Feasibility of the intervention as measured by QoL surveys	Feasibility of the intervention is measured by administering Quality of Life (QoL) surveys using Quality of Recovery-40 questionnaire. This is a self-rated questionnaire for early postoperative quality of recovery and health status of patients. Possible scores range from 1 to 5, where higher scores indicate better quality of life (i.e., 1 = very poor and 5 = excellent)	6 weeks post-discharge
Change in pain score from baseline as measured by visual analog pain scale at prior to discharge home (approx. 4-6 hours post treatment)	Change in pain score from baseline is measured by visual analog pain scale at prior to discharge home (approx. 4-6 hours post treatment). Possible scores range from 0-10, where 0= no pain and 10= worst pain.	Baseline, prior to discharge home (approx. 4-6 hours post treatment)
Change in pain score from baseline as measured by visual analog pain scale at 1-2 weeks post discharge	Change in pain score from baseline is measured by visual analog pain scale at weeks post discharge. Possible scores range from 0-10, where 0= no pain and 10= worst pain.	Baseline, 1-2 weeks post discharge
Change in pain score from baseline as measured by visual analog pain scale at 6 weeks post discharge	Change in pain score from baseline is measured by visual analog pain scale at 6 weeks post discharge. Possible scores range from 0-10, where 0= no pain and 10= worst pain.	Baseline, 6 weeks post discharge
Change in cognitive function as measured by CAM assessment form at 1-2 weeks post discharge	Change in cognitive function is measured by Short Confusion Assessment Method (CAM) Questionnaire at 1-2 weeks post discharge. If Inattention and at least one other item ( regarding acute change in mental status; inattention) in Box 1 of the questionnaire are checked and at least one item (regarding disorganized thinking; altered level of consciousness) in Box 2 of the questionnaire is checked, then a diagnosis of delirium is suggested.	Baseline, 1-2 weeks post discharge
Change in cognitive function as measured by CAM assessment form at 6 weeks post discharge	Change in cognitive function is measured by Short Confusion Assessment Method (CAM) Questionnaire at 6 weeks post discharge. If Inattention and at least one other item ( regarding acute change in mental status; inattention) in Box 1 of the questionnaire are checked and at least one item (regarding disorganized thinking; altered level of consciousness) in Box 2 of the questionnaire is checked, then a diagnosis of delirium is suggested.	Baseline, 6 weeks post discharge
Feasibility of the intervention as measured by physical function using FRAIL scale	Feasibility of the intervention is measured by physical function using FRAIL scale. The Fatigue Resistance Ambulation Illness and Loss of weight (FRAIL) scale includes 5 components: Fatigue, Resistance, Ambulation, Illness, and Loss of weight. Frail scale scores range from 0-5 (i.e., 1 point for each component; 0=best to 5=worst) and represent frail (3-5), pre-frail (1-2), and robust (0) health status.	Baseline
Feasibility of the intervention as measured by hospital costs for each enrolled participant (Antibiotics Group)	Feasibility of the intervention is measured by accessing billing codes/hospital costs for each enrolled subject from the time they are admitted until they are discharged from the hospital.	the day of discharge (approx. 1-3 days post treatment)
Feasibility of the intervention as measured by hospital costs for each enrolled participant (Operative Group)	Feasibility of the intervention is measured by accessing billing codes/hospital costs for each enrolled subject from the time they are admitted until they are discharged from the hospital.	the day of discharge (approx. 0-2 days post treatment)

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Sneha Bhat, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: December 18, 2022
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Disease Attributes; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Acute Disease; Appendicitis; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: STU-2021-0035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No