Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCedars-Sinai Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Age < 18 years or > 65 years.

Pregnancy.

Homelessness.

Patients who present with generalized peritonitis.

Trial design

Design model

Single group

Treatments tested in this trial

  • Discharge on oral antibiotics

    Other intervention

    Patients will be discharged to home on an oral antibiotic regimen for 3 days instead of being admitted for intravenous antibiotics.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: ERASOther 1 intervention

Trial outcomes

Primary outcomes

1

Readmission rate

Feasibility will be determined by the readmission within 30 days rate for any reason

Time frame
30 days
2

Postoperative infections

Safety will be assessed by the incidence of postoperative infectious complications

Time frame
30 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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