search
Back to results

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

Primary Purpose

Acute Appendicitis

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Laparoscopic appendectomy
Antibiotics (IV transitioned to oral)
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Appendicitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Operative Arm

    Non-Operative Arm

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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
    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

    Secondary Outcome Measures

    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
    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
    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
    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
    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)
    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)
    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)
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    December 18, 2022
    Last Updated
    February 9, 2023
    Sponsor
    University of Texas Southwestern Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05724628
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    November 2023 (Anticipated)
    Study Completion Date
    November 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Texas Southwestern Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Appendicitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Operative Arm
    Arm Type
    Experimental
    Arm Description
    Operation (laparoscopic appendectomy) will be performed to remove appendix.
    Arm Title
    Non-Operative Arm
    Arm Type
    Experimental
    Arm Description
    No operation will be performed, and instead, will receive intra-venous (IV) antibiotics, transitioned to by mouth (oral) antibiotics
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic appendectomy
    Intervention Description
    Subjects will receive surgery (using 3 port Laparoscopic appendectomy) to remove appendix
    Intervention Type
    Drug
    Intervention Name(s)
    Antibiotics (IV transitioned to oral)
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Feasibility of the intervention as measured by the proportion of enrolled participants retained in this study
    Description
    Feasibility of the intervention is measured by the proportion of enrolled participants who are randomized and retained in this study
    Time Frame
    12 months post treatment
    Title
    Feasibility of the intervention as measured by the number of complications or adverse events
    Description
    Feasibility of the intervention is measured by the number of complications or adverse events encountered by participants while enrolled in this study
    Time Frame
    12 months post treatment
    Secondary Outcome Measure Information:
    Title
    Feasibility of the intervention as measured by total length of hospital stay (Antibiotics Group)
    Description
    Feasibility of the intervention is measured by total number of days in inpatient hospital stay for the IV antibiotics group post treatment
    Time Frame
    the day of discharge (approx. 1-3 days post treatment)
    Title
    Feasibility of the intervention as measured by total length of hospital stay (Operative Group)
    Description
    Feasibility of the intervention is measured by total number of days in inpatient hospital stay for the Operative group post laparoscopic appendectomy
    Time Frame
    the day of discharge (approx. 0-2 days post treatment)
    Title
    Feasibility of the intervention as measured by the number of hospital readmissions or emergency room visits
    Description
    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
    Time Frame
    1-2 weeks post-discharge
    Title
    Feasibility of the intervention as measured by the number of hospital readmissions or emergency room visits
    Description
    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
    Time Frame
    6 weeks post-discharge
    Title
    Feasibility of the intervention as measured by QoL surveys
    Description
    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)
    Time Frame
    prior to discharge home (approx. 4-6 hours post treatment)
    Title
    Feasibility of the intervention as measured by QoL surveys
    Description
    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)
    Time Frame
    1-2 weeks post-discharge
    Title
    Feasibility of the intervention as measured by QoL surveys
    Description
    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)
    Time Frame
    6 weeks post-discharge
    Title
    Change in pain score from baseline as measured by visual analog pain scale at prior to discharge home (approx. 4-6 hours post treatment)
    Description
    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.
    Time Frame
    Baseline, prior to discharge home (approx. 4-6 hours post treatment)
    Title
    Change in pain score from baseline as measured by visual analog pain scale at 1-2 weeks post discharge
    Description
    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.
    Time Frame
    Baseline, 1-2 weeks post discharge
    Title
    Change in pain score from baseline as measured by visual analog pain scale at 6 weeks post discharge
    Description
    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.
    Time Frame
    Baseline, 6 weeks post discharge
    Title
    Change in cognitive function as measured by CAM assessment form at 1-2 weeks post discharge
    Description
    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.
    Time Frame
    Baseline, 1-2 weeks post discharge
    Title
    Change in cognitive function as measured by CAM assessment form at 6 weeks post discharge
    Description
    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.
    Time Frame
    Baseline, 6 weeks post discharge
    Title
    Feasibility of the intervention as measured by physical function using FRAIL scale
    Description
    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.
    Time Frame
    Baseline
    Title
    Feasibility of the intervention as measured by hospital costs for each enrolled participant (Antibiotics Group)
    Description
    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.
    Time Frame
    the day of discharge (approx. 1-3 days post treatment)
    Title
    Feasibility of the intervention as measured by hospital costs for each enrolled participant (Operative Group)
    Description
    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.
    Time Frame
    the day of discharge (approx. 0-2 days post treatment)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ana Garzon
    Phone
    469/571-0840
    Email
    Ana.Garzon@UTSouthwestern.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sneha Bhat
    Organizational Affiliation
    UT Southwestern Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs