Enhanced recovery protocol for patients with complicated appendicitis
Enhanced Recovery Protocol for Acute, Complicated Appendicitis After Laparoscopic Appendectomy: An Exploratory Pilot Study
This study is testing a new recovery plan for adults with complicated appendicitis to see if it helps them heal better and go home sooner after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06948071 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility and safety of an enhanced recovery protocol for adult patients undergoing laparoscopic appendectomy for complicated appendicitis. Patients will be discharged on an oral antibiotic regimen for three days post-surgery. The study will assess feasibility through patient compliance with postoperative instructions and safety by monitoring the incidence of postoperative infectious complications and readmissions. The goal is to improve recovery outcomes and reduce hospital stays.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who are undergoing laparoscopic appendectomy for complicated appendicitis.
Not a fit: Patients outside the age range of 18 to 65, those with generalized peritonitis, or significant comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to quicker recoveries and reduced hospital stays for patients with complicated appendicitis.
How similar studies have performed: While enhanced recovery protocols have shown success in various surgical fields, this specific approach for complicated appendicitis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Galinos Barmparas, MD — Cedars-Sinai Medical Center
- Study coordinator: Laura Sarmiento, CCRP
- Email: laura.sarmiento@cshs.org
- Phone: 310-423-4295
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.