Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-21

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Appendicitis Acute Appendicitis Perforated Appendicitis With Perforation Appendicitis Suppurative Appendicitis Gangrenous

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ERAS

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

Group Type OTHER

Discharge on oral antibiotics

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No