Clinical trial NCT06948071: Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis
Official title: Enhanced Recovery Protocol for Acute, Complicated Appendicitis After Laparoscopic Appendectomy: An Exploratory Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Appendicitis Acute
Appendicitis Perforated
Appendicitis With Perforation
Appendicitis Suppurative
Appendicitis Gangrenous
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Readmission rate
timeFrame: 30 days
measure: Postoperative infections
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Galinos Barmparas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Rossem CC, Schreinemacher MH, van Geloven AA, Bemelman WA; Snapshot Appendicitis Collaborative Study Group. Antibiotic Duration After Laparoscopic Appendectomy for Acute Complicated Appendicitis. JAMA Surg. 2016 Apr;151(4):323-9. doi: 10.1001/jamasurg.2015.4236.
citation: van den Boom AL, de Wijkerslooth EML, Giesen LJX, van Rossem CC, Toorenvliet BR, Wijnhoven BPL. Postoperative Antibiotics and Time to Reach Discharge Criteria after Appendectomy for Complex Appendicitis. Dig Surg. 2022;39(4):162-168. doi: 10.1159/000526790. Epub 2022 Aug 30.
citation: Kleif J, Rasmussen L, Fonnes S, Tibaek P, Daoud A, Lund H, Gogenur I. Enteral Antibiotics are Non-inferior to Intravenous Antibiotics After Complicated Appendicitis in Adults: A Retrospective Multicentre Non-inferiority Study. World J Surg. 2017 Nov;41(11):2706-2714. doi: 10.1007/s00268-017-4076-6.