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NCT Number: NCT06948071

Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Galinos Barmparas, MD

PRINCIPAL_INVESTIGATOR

Laura Sarmiento, CCRP

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Discharge on oral antibiotics

Other

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

Primary outcomes

  1. Readmission rate

    Time frame: 30 days

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

  2. Postoperative infections

    Time frame: 30 days

    Safety will be assessed by the incidence of postoperative infectious complications

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Sarmiento, CCRP

CONTACT

[email protected]

310-423-4295

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

Enhanced Recovery Protocol for Acute, Complicated Appendicitis After Laparoscopic Appendectomy: An Exploratory Pilot Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 29, 2025
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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