Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis

Cedars-Sinai Medical Center

Status: Enrolling

Conditions: Appendicitis Suppurative; Appendicitis With Perforation; Appendicitis Perforated; Appendicitis Acute; Appendicitis Gangrenous

Treatments: Other: Discharge on oral antibiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT06948071

STUDY00003804

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

ERAS

Other group

Description:

Patients with intraoperative diagnosis of complicated appendicitis as determined by the operating surgeon.

Treatment:

Other: Discharge on oral antibiotics