RECRUITING

Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Enhanced Recovery Protocol for Acute, Complicated Appendicitis After Laparoscopic Appendectomy: An Exploratory Pilot Study

Quick Facts

Study Start:2025-04-21
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06948071

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals between the ages of 18 and 65 years of age.
  2. * Patients undergoing a laparoscopic appendectomy.
  3. * 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.
  4. * Meet criteria for discharge from the post-anesthesia care unit (PACU).
  5. * Ability to reliably follow up with the study procedures.
  1. * Age \< 18 years or \> 65 years.
  2. * Pregnancy.
  3. * Homelessness.
  4. * Patients who present with generalized peritonitis.
  5. * Patients with comorbid conditions, including diabetes mellitus, immunosuppressed state for any reason, patients on chronic anticoagulation (excluding Aspirin 81 mg).
  6. * Patients who present with septic shock.
  7. * Patients who require conversion to an open appendectomy.
  8. * Patients who present with additional findings on imaging studies or intra-operatively, including ileus or small bowel obstruction.
  9. * Based on surgeon's clinical judgment for reasons that may not be outlined above.
  10. * Allergy or intolerance to study medication(s)

Contacts and Locations

Study Contact

Laura Sarmiento, CCRP
CONTACT
310-423-4295
laura.sarmiento@cshs.org

Principal Investigator

Galinos Barmparas, MD
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

  • Galinos Barmparas, MD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-21
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2025-04-21
Study Completion Date2026-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Appendicitis Acute
  • Appendicitis Perforated
  • Appendicitis With Perforation
  • Appendicitis Suppurative
  • Appendicitis Gangrenous