Appendicitis Acute, Appendicitis Gangrenous, Appendicitis Perforated, Appendicitis Suppurative, Appendicitis With Perforation
Conditions
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.
Interventions
OTHERDischarge on oral antibiotics
Patients will be discharged to home on an oral antibiotic regimen for 3 days instead of being admitted for intravenous antibiotics.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactLaura Sarmiento, CCRP
Outcome results
None listed