Enteral 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/Actively Recruiting
Led by Cedars-Sinai Medical Center · Updated on 2025-04-29
20
Participants Needed
1
Research Sites
8 weeks
Total Duration
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
Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis
L
Laura Sarmiento, CCRP
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Cedars-Sinai Medical Center
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Discharge with Oral Antibiotics (Trial Protocol) | Inpatient IV Antibiotics (Standard Care) |
|---|---|---|
| What is it? | After laparoscopic removal of the appendix for complicated appendicitis, patients are discharged to home with a 3-day regimen of oral antibiotics instead of remaining in hospital for intravenous antibiotics. | Patients usually stay in hospital after laparoscopic appendectomy for complicated appendicitis, receiving intravenous antibiotics for several days as part of standard postoperative care. |
| Role in the study | All eligible participants receive the oral antibiotic discharge protocol. There is no internal comparator arm in this single-group study. | Serves as the external current-care comparator for post-surgical management of complicated appendicitis outside the trial context. |
| Primary use | To reduce hospital stay and enable earlier discharge by providing oral antibiotics at home for patients with complicated appendicitis who meet discharge criteria after laparoscopic surgery. | To prevent postoperative infection and complications using intravenous antibiotics delivered in hospital after surgery for complicated appendicitis. |
| How is it given/performed? | Eligible patients are discharged from the post-anesthesia care unit and prescribed 3 days of oral antibiotics to take at home. | Patients remain hospitalized after surgery and receive intravenous antibiotics over several days, typically until clinical recovery is assured. |
| Important limitations | Single-group design, limited sample size, and strict inclusion criteria; full safety and effectiveness for oral antibiotics require further confirmation in larger, randomized studies. | Inpatient intravenous antibiotics may prolong hospital stay and increase healthcare resource use; not always necessary for all low-risk patients. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Duration - 30 days
Participants are followed for 30 days to monitor readmission rates and postoperative infections.
Approximately 1 to 2 follow-up visits
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/36041400/Cedars-Sinai Medical Center
Lead Sponsor