Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis
Recruiting now · Not applicable
Conditions studied: Appendicitis Acute, Appendicitis Perforated, Appendicitis With Perforation, Appendicitis Suppurative, Appendicitis Gangrenous
In brief
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 regimen for three days following a laparoscopic appendectomy for complicated appendicitis. Feasibility will be determined by high compliance and adherence of patients to the postoperative instructions, while safety will be assessed by the incidence of postoperative infectious complications and requirement for re-admission.
Key facts
- Study ID
- NCT06948071
- Run by
- Cedars-Sinai Medical Center
- People needed
- 20
- Starts
- 2025-04-21
- Expected to finish
- 2026-02-28
- Last updated by the study team
- 2025-04-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
Full record on ClinicalTrials.gov
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