Recruiting

ERAS

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT06948071

Conditions

Appendicitis Acute

Appendicitis Perforated

Appendicitis With Perforation

Appendicitis Suppurative

Appendicitis Gangrenous

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Discharge on oral antibiotics

Study Details

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.

Conditions

Appendicitis Acute

Appendicitis Perforated

Appendicitis With Perforation

Appendicitis Suppurative

Appendicitis Gangrenous

Study ID

NCT06948071

Start date

Apr 21, 2025

Status verified date

Apr, 2025

Completion date

Feb 28, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: ERAS

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

Interventions

Discharge on oral antibiotics

Patients will be discharged to home on an oral antibiotic regimen for 3 days instead of being admitted for intravenous antibiotics.

Primary outcome measure

  • Readmission rate [ Time Frame: 30 days ]
  • Postoperative infections [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Laura Sarmiento, CCRP

310-423-4295laura.sarmiento@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Principal Investigator:

Galinos Barmparas, MD

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Apr 29, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2025-04-29.