Acute AppendicitisPhase 1NCT05724628
Non-operative vs. Operative Management of Acute Appendicitis in Vulnerable Patient Populations
A Phase 1 study testing Laparoscopic appendectomy and Antibiotics (IV transitioned to oral) in people with Acute Appendicitis, run by University of Texas Southwestern Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- Laparoscopic appendectomy and Antibiotics (IV transitioned to oral)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Able to consent for the study
- Diagnosis of acute appendicitis confirmed by CT imaging
Who cannot join
- 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)
About this study
Official title: 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.
Read the 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
- Being tested
- Laparoscopic appendectomy, Antibiotics (IV transitioned to oral)
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic appendectomyProcedure or surgery
Subjects will receive surgery (using 3 port Laparoscopic appendectomy) to remove appendix
Antibiotics (IV transitioned to oral)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
| Study group | Role | What they receive |
|---|---|---|
| Operative Arm | Experimental | Operation (laparoscopic appendectomy) will be performed to remove appendix. Receives: Procedure: Laparoscopic appendectomy |
| Non-Operative Arm | Experimental | No operation will be performed, and instead, will receive intra-venous (IV) antibiotics, transitioned to by mouth (oral) antibiotics Receives: Drug: Antibiotics (IV transitioned to oral) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 months post treatment
Secondary outcomes (15)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: the day of discharge (approx. 0-2 days post treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study startOct 2023 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Why it stopped: Project did not receive final IRB approvals. PI decided to withdrawn research study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sneha Bhat, University of Texas Southwestern Medical Center
- Investigators
- Sneha Bhat, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724628
- Sponsor's protocol ID
- STU-2021-0035
- Status last verified
- Mar 2024
- First submitted
- 18 Dec 2022
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Trial of Non-operative Versus Operative Management of Acute Appendicitis in Vulnerable Patient Populations
- ClinicalTrials.gov ID
- NCT05724628
- Acronym / sponsor ID
- STU-2021-0035
- Conditions
- Acute Appendicitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project did not receive final IRB approvals. PI decided to withdrawn research study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative Arm | Experimental | Procedure: Laparoscopic appendectomyOperation (laparoscopic appendectomy) will be performed to remove appendix. |
| Non-Operative Arm | Experimental | Drug: Antibiotics (IV transitioned to oral)No operation will be performed, and instead, will receive intra-venous (IV) antibiotics, transitioned to by mouth (oral) antibiotics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Able to consent for the study
- Diagnosis of acute appendicitis confirmed by CT imaging
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic appendectomySubjects will receive surgery (using 3 port Laparoscopic appendectomy) to remove appendix | Procedure or surgery | Operative Arm |
| 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 | Drug | Non-Operative Arm |
Primary outcome
Feasibility of the intervention as measured by the proportion of enrolled participants retained in this study
Time frame: 12 months post treatment
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
Time frame: 12 months post treatment
Feasibility of the intervention is measured by the number of complications or adverse events encountered by participants while enrolled in this study
15 secondary outcomes
Feasibility of the intervention as measured by total length of hospital stay (Antibiotics Group)
Time frame: the day of discharge (approx. 1-3 days post treatment)
Feasibility of the intervention as measured by total length of hospital stay (Operative Group)
Time frame: 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
Time frame: 1-2 weeks post-discharge
Feasibility of the intervention as measured by the number of hospital readmissions or emergency room visits
Time frame: 6 weeks post-discharge
Feasibility of the intervention as measured by QoL surveys
Time frame: prior to discharge home (approx. 4-6 hours post treatment)
Feasibility of the intervention as measured by QoL surveys
Time frame: 1-2 weeks post-discharge
Feasibility of the intervention as measured by QoL surveys
Time frame: 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)
Time frame: 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
Time frame: Baseline, 1-2 weeks post discharge
Change in pain score from baseline as measured by visual analog pain scale at 6 weeks post discharge
Time frame: Baseline, 6 weeks post discharge
Change in cognitive function as measured by CAM assessment form at 1-2 weeks post discharge
Time frame: Baseline, 1-2 weeks post discharge
Change in cognitive function as measured by CAM assessment form at 6 weeks post discharge
Time frame: Baseline, 6 weeks post discharge
Feasibility of the intervention as measured by physical function using FRAIL scale
Time frame: Baseline
Feasibility of the intervention as measured by hospital costs for each enrolled participant (Antibiotics Group)
Time frame: 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)
Time frame: the day of discharge (approx. 0-2 days post treatment)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sneha Bhat principal investigator
University of Texas Southwestern Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Laparoscopic appendectomy and Antibiotics (IV transitioned to oral) in people with Acute Appendicitis, run by University of Texas Southwestern Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention as measured by the proportion of enrolled participants retained in this study (time frame: 12 months post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.