Antibiotic Duration After Laparoscopic Appendectomy for Acute Complicated Appendicitis.
Charles C van Rossem, Marc H F Schreinemacher, Anna A W van Geloven...
https://pubmed.ncbi.nlm.nih.gov/26580850Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06948071
Enhanced Recovery Protocol for Acute, Complicated Appendicitis After Laparoscopic Appendectomy: An Exploratory Pilot Study
Led by Cedars-Sinai Medical Center · Updated on 2025-04-29
20
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an enhanced recovery protocol for adults with complicated appendicitis who undergo laparoscopic appendectomy. The study aims to assess whether discharging patients home on an oral antibiotic regimen for three days after surgery is feasible and safe. Safety will be measured by tracking postoperative infections and readmission rates within 30 days. This pilot study is exploratory and sponsored by Cedars-Sinai Medical Center. Participants will receive oral antibiotics at home for three days instead of staying hospitalized for intravenous antibiotics after their laparoscopic appendectomy. The study includes patients diagnosed with complicated appendicitis, such as perforated, gangrenous, suppurative appendicitis, or iatrogenic appendix perforation, confirmed during surgery. Patients must meet discharge criteria from the post-anesthesia care unit to be eligible. During the study, participants will be monitored for adherence to postoperative instructions and any infectious complications. Researchers will evaluate compliance, safety outcomes, and the need for hospital readmission within 30 days after surgery. The total study period includes follow-up assessments during this 30-day postoperative window to observe recovery and complications.
CONDITIONS
Brief Title
Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Individuals between the ages of 18 and 65 years
- Undergoing a laparoscopic appendectomy
- Diagnosis of complicated appendicitis including perforated, gangrenous, suppurative appendicitis, or iatrogenic appendix perforation
- Meet criteria for discharge from the post-anesthesia care unit (PACU)
- Ability to reliably follow up with study procedures
You will not qualify if you...
- Age under 18 years or over 65 years
- Pregnancy
- Homelessness
- Generalized peritonitis
- Comorbid conditions such as diabetes mellitus, immunosuppressed state, or chronic anticoagulation (except Aspirin 81 mg)
- Septic shock
- Conversion to open appendectomy
- Additional findings like ileus or small bowel obstruction
- Allergy or intolerance to study medications
- Any other exclusions based on surgeon's clinical judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 days
Participants undergo laparoscopic appendectomy followed by discharge on an oral antibiotic regimen for 3 days instead of intravenous antibiotics.
1 hospital stay and discharge visit
Follow-up
Duration - 30 days
Participants are followed for 30 days to monitor readmission rates and postoperative infections.
Approximately 1 to 2 follow-up visits
Trial Site Locations
Total: 1 location
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
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Research Team
L
Laura Sarmiento, CCRP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Postoperative Antibiotics and Time to Reach Discharge Criteria after Appendectomy for Complex Appendicitis.
Anne Loes van den Boom, Elisabeth M L de Wijkerslooth, Louis J X Giesen...
https://pubmed.ncbi.nlm.nih.gov/36041400Enteral Antibiotics are Non-inferior to Intravenous Antibiotics After Complicated Appendicitis in Adults: A Retrospective Multicentre Non-inferiority Study.
Jakob Kleif, Louise Rasmussen, Siv Fonnes...
https://pubmed.ncbi.nlm.nih.gov/28600695