NCT06948071 · Cedars-Sinai Medical Center
Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis
What this study is 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 taken by mouth antibiotic regimen for three days following a laparoscopic appendectomy for complicated appendicitis.
View original scientific 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.
Interventions
OTHER
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 measures
Readmission rate
Time frame: 30 days
Feasibility will be determined by the readmission within 30 days rate for any reason
Postoperative infections
Time frame: 30 days
Safety will be assessed by the incidence of postoperative infectious complications
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- 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
- Los Angeles, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 29, 2025 · Source of record for eligibility and locations