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

NCT05724628 | Withdrawn Phase 1

• 1 other identifier: STU-2021-0035
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Appendicitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (15)

• Feasibility of the intervention as measured by total length of hospital stay (Antibiotics Group)

  the day of discharge (approx. 1-3 days post treatment)

• Feasibility of the intervention as measured by total length of hospital stay (Operative Group)

  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

  1-2 weeks post-discharge

• Feasibility of the intervention as measured by the number of hospital readmissions or emergency room visits

  6 weeks post-discharge

• Feasibility of the intervention as measured by QoL surveys

  prior to discharge home (approx. 4-6 hours post treatment)

Study Arms (2)

Operative Arm

EXPERIMENTAL

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

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

Drug: Antibiotics (IV transitioned to oral)

Interventions

Laparoscopic appendectomy PROCEDURE

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

Operative Arm

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

Non-Operative Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Able to consent for the study
• Diagnosis of acute appendicitis confirmed by CT imaging

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

MeSH Terms

Conditions

Appendicitis

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Sneha Bhat

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT PROFESSOR - Surgery

Study Record Dates

• First Submitted: December 18, 2022
• First Posted: February 13, 2023
• Study Start: October 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share