Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis

Not Applicable

Recruiting

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

• Registration Number: NCT06948071
• Lead Sponsor: Cedars-Sinai Medical Center

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04-21
• Study First Submitted: 2025-04-22
• Study First Submitted QC: 2025-04-22
• Last Update Submitted: 2025-04-22
• Study First Posted: 2025-04-29
• Last Update Posted: 2025-04-29
• Primary Completion: 2025-12-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Readmission rate	30 days	Feasibility will be determined by the readmission within 30 days rate for any reason
Postoperative infections	30 days	Safety will be assessed by the incidence of postoperative infectious complications

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States