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Search / Trial NCT04168866

Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon

Launched by YALE UNIVERSITY · Nov 16, 2019

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to treat complicated appendicitis, which is when the appendix becomes inflamed and forms an abscess or a mass of infected tissue. The researchers want to find out if surgery right away is better than treating the condition with antibiotics and careful monitoring. They are looking for adult patients between the ages of 65 and 74 who have been diagnosed with complicated appendicitis through a CT scan and have a significant abscess or phlegmon that is larger than 2 centimeters.

To be eligible for this trial, participants must not have received antibiotics for more than 24 hours before considering enrollment, and they should not have had any previous major abdominal surgery. Pregnant women and those with certain serious health conditions will not be included in the study. If you join the trial, you can expect to either have surgery or be treated without surgery, and the team will closely monitor your health throughout the process. This study is important because it may help doctors determine the best way to treat complicated appendicitis in older adults.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Complicated appendicitis with presumed perforation on (computer tomography) CT scan AND phlegmon or abscess greater than 2 centimeter (cm).
  • Exclusion Criteria:
  • 1. Antibiotic therapy greater than 24 hours prior to considering for enrollment.
  • 2. Attempted drainage before randomization
  • 3. Pregnancy
  • 4. Antibiotic allergy requiring the use of something other than a beta-lactam or quinolone based therapy.
  • 5. Previous major intra-abdominal surgery by laparotomy
  • 6. Hospitalization within 2 weeks of randomization
  • 7. Presence of septic shock on admission.
  • 8. Mechanical ventilation
  • 9. Acute renal failure requiring dialysis

About Yale University

Yale University, a prestigious Ivy League institution located in New Haven, Connecticut, is renowned for its commitment to advancing medical research and clinical innovation. With a rich history of academic excellence and a robust infrastructure for scientific inquiry, Yale serves as a leading sponsor for clinical trials aimed at improving patient care and developing new therapeutic approaches. The university's multidisciplinary teams of researchers and clinicians collaborate to conduct rigorous and ethical studies, leveraging cutting-edge technologies and methodologies to address critical health challenges. Through its dedication to fostering an environment of inquiry and discovery, Yale University plays a pivotal role in translating research findings into clinical practice, ultimately enhancing health outcomes for diverse populations.

Locations

New Haven, Connecticut, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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