Comparing surgery and non-surgery for complicated appendicitis
Official title: Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon
Run by Yale University · NCT04168866 · Data updated 2026-11-12
This study is testing whether surgery or non-surgery works better for adults with complicated appendicitis that includes an abscess or phlegmon.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Status | Recruiting |
| Started | March 11, 2020 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2029 |
| Registry record updated | August 29, 2025 |
| Trial ID | NCT04168866 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults diagnosed with complicated appendicitis with a CT scan showing an abscess or phlegmon larger than 2 cm.
✕Probably not a fit
Patients who have received antibiotic therapy for more than 24 hours prior to enrollment or those with severe complications such as septic shock may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate whether early surgical intervention is more effective than non-surgical management for adults with CT-confirmed complicated appendicitis that includes an abscess or phlegmon. The research will involve a multi-center approach in the United States, allowing patients to choose between operative and non-operative treatments. The study builds on previous findings from Finland that suggested surgical management may lead to better outcomes, such as shorter hospital stays and fewer complications. By conducting this trial, the investigators hope to provide clearer guidance on the best treatment options for this challenging condition.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for patients with complicated appendicitis, potentially reducing complications and hospital stays.
How similar studies have gone: Previous studies, particularly a randomized controlled trial in Finland, have shown success with similar approaches, although this study aims to provide high-quality evidence in the United States.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Yale New Haven Hospital
New Haven, Connecticut, United States Recruiting
Study contacts
- Study coordinator: Kevin Schuster, MD, MPH
- Email: kevin.schuster@yale.edu
- Phone: 203 785 2572
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study looks at how appendicitis is treated in hospitals around the world to see if improvements can be made for all patients needing surgery.
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Comparing Ketorolac and Morphine for Pain Relief in Children with Appendicitis
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.