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Recruiting NCT06948071

Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis

No phase Interventional Appendicitis Acute Appendicitis Perforated Appendicitis With Perforation Appendicitis Suppurative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Discharge on oral antibiotics.
Who it may be relevant to
Registry conditions: Appendicitis Acute, Appendicitis Perforated, Appendicitis With Perforation, Appendicitis Suppurative. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Readmission rate [Time frame: 30 days]
  • Postoperative infections [Time frame: 30 days]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Cedars-Sinai Medical Center — Los Angeles

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. PMID 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. PMID 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. PMID 28600695

Identifiers

NCT: NCT06948071 · STUDY00003804

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗