ClinicalTrials.gg
RecruitingNCT06948071Updated Apr 29, 2025

Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis

An interventional study of Discharge on oral antibiotics in Appendicitis Acute, Appendicitis Perforated and Appendicitis With Perforation, sponsored by Cedars-Sinai Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-29.

Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Appendicitis Acute
  • Appendicitis Perforated
  • Appendicitis With Perforation
  • Appendicitis Suppurative
  • Appendicitis Gangrenous

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03

In context

Appendicitis

419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.

This study's planned enrollment of 20 is below the median of 111 across 252 interventional studies indexed under Appendicitis.

Browse Appendicitis studies →

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 456 studies on the registry; 107 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 49 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Age \< 18 years or > 65 years.
  • Pregnancy.
  • Homelessness.
  • Patients who present with generalized peritonitis.
  • Patients with comorbid conditions, including diabetes mellitus, 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    ERAS

    Patients with intraoperative diagnosis of complicated appendicitis as determined by the operating surgeon.

    Other: Discharge on oral antibiotics

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.

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
    Recruiting
    • Laura Sarmiento, CCRP · Contact
    • Galinos Barmparas, MD · Principal investigator
08

References and documents

Publications

  • 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. PubMed 26580850 ↗
  • 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. PubMed 36041400 ↗
  • 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. PubMed 28600695 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06948071
Responsible party
Galinos Barmparas, MD (Staff Physician II, Cedars-Sinai Medical Center) — Principal investigator
First posted
Apr 29, 2025
Start date
Apr 21, 2025 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Feb 28, 2026 (estimated)
Last update
Apr 29, 2025

Study contacts

Laura Sarmiento, CCRP
Contact
laura.sarmiento@cshs.org
310-423-4295
Galinos Barmparas, MD
principal investigator · Cedars-Sinai Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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