NCT04168866 Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon
| NCT ID | NCT04168866 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yale University |
| Condition | Appendicitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2020-03-11 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2020-03-11 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators aim to determine if early operative intervention is superior to non-operative management for adult patients with computerized tomography (CT)-proven complicated appendicitis with phlegmon or abscess.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04168866 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Appendicitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04168866 currently recruiting?
Yes, NCT04168866 is actively recruiting participants. Contact the research team at kevin.schuster@yale.edu for enrollment information.
Where is the NCT04168866 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT04168866 clinical trial?
NCT04168866 is sponsored by Yale University. The trial plans to enroll 180 participants.