Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis (NCT06948071) | Clinical Trial Compass
RecruitingNot Applicable
Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis
United States20 participantsStarted 2025-04-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.