Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis

NCT06948071 | Recruiting

• 1 other identifier: STUDY00003804
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis Acute; Appendicitis Perforated; Appendicitis With Perforation; Appendicitis Suppurative; Appendicitis Gangrenous

Outcome Measures

Primary Outcomes (2)

• Readmission rate

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

  30 days

• Postoperative infections

  Safety will be assessed by the incidence of postoperative infectious complications

  30 days

Study Arms (1)

ERAS

OTHER

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

Other: Discharge on oral antibiotics

Interventions

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.

ERAS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 26580850 BACKGROUND

• 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.

  PMID: 36041400 BACKGROUND

• 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.

  PMID: 28600695 BACKGROUND

Related Links

• Postoperative antibiotic therapy after appendectomy in patients with non-perforated appendicitis - PMC.

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Galinos Barmparas, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Sarmiento, CCRP

CONTACT

310-423-4295; laura.sarmiento@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician II

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: April 21, 2025
• Primary Completion: December 31, 2025
• Study Completion: February 28, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

US (1)