Status:
RECRUITING
Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Appendicitis Acute
Appendicitis Perforated
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The exploratory objective of this pilot study is to evaluate the feasibility and safety of an enhanced recovery protocol that will allow adult patients to be discharged to home on an oral antibiotic r...
Eligibility Criteria
Inclusion
- Individuals between the ages of 18 and 65 years of age.
- Patients undergoing a laparoscopic appendectomy.
- Diagnosis of complicated appendicitis based on pre-operative imaging or intra-operative assessment. The definition of a complicated appendicitis will include: (a) perforated appendicitis, without generalized peritonitis; (b) gangrenous appendicitis, without generalized peritonitis; (c) suppurative appendicitis; (d) iatrogenic perforation of the appendix.
- Meet criteria for discharge from the post-anesthesia care unit (PACU).
- Ability to reliably follow up with the study procedures.
Exclusion
- Age \< 18 years or \> 65 years.
- Pregnancy.
- Homelessness.
- Patients who present with generalized peritonitis.
- Patients with comorbid conditions, including diabetes mellitus, immunosuppressed state for any reason, patients on chronic anticoagulation (excluding Aspirin 81 mg).
- Patients who present with septic shock.
- Patients who require conversion to an open appendectomy.
- Patients who present with additional findings on imaging studies or intra-operatively, including ileus or small bowel obstruction.
- Based on surgeon's clinical judgment for reasons that may not be outlined above.
- Allergy or intolerance to study medication(s)
Key Trial Info
Start Date :
April 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06948071
Start Date
April 21 2025
End Date
February 28 2026
Last Update
April 29 2025
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048