Enhanced Recovery After Surgery for Appendicitis

Overseen By Laura Sarmiento, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Must not be taking: Chronic anticoagulants

Disqualifiers: Diabetes, Immunosuppressed, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 days

20 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on chronic anticoagulation (blood thinners) other than Aspirin 81 mg, you may not be eligible to participate.

What data supports the effectiveness of the treatment Enhanced Recovery After Surgery (ERAS) for appendicitis?

Research shows that ERAS, a treatment plan designed to help patients recover faster after surgery, has been successfully used in children with appendicitis, improving recovery and reducing hospital stays. Additionally, ERAS has shown positive results in other surgeries, like colorectal surgery, by optimizing recovery and reducing complications. ^{1 2 3 4 5}

Is Enhanced Recovery After Surgery (ERAS) safe for humans?

Enhanced Recovery After Surgery (ERAS) is generally considered safe and has been successfully used in both adults and children for various surgeries, including colorectal and appendicitis surgeries. It is a structured program designed to help patients recover faster after surgery. ^{1 2 6 7 8}

How is the Enhanced Recovery After Surgery (ERAS) treatment different from other treatments for appendicitis?

Enhanced Recovery After Surgery (ERAS) is a unique approach that focuses on a multimodal strategy to improve recovery after surgery. Unlike traditional methods, ERAS involves a combination of techniques such as optimizing nutrition, minimizing fasting, and encouraging early mobilization (getting up and moving) to speed up recovery and reduce hospital stay. ^{1 2 3 5 9}

What is the purpose of this trial?

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.

Research Team

Galinos Barmparas, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

This trial is for adults who've had a laparoscopic appendectomy due to complicated appendicitis, including perforated or gangrenous conditions. Participants should be able to follow postoperative instructions at home.

Inclusion Criteria

I am having surgery to remove my appendix using a camera.

I have been diagnosed with a severe form of appendicitis.

I am cleared to leave the recovery room after anesthesia.

Exclusion Criteria

Pregnancy

Homelessness

Based on surgeon's clinical judgment for reasons that may not be outlined above

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo laparoscopic appendectomy followed by an oral antibiotic regimen for three days

3 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on readmission and postoperative infections

30 days

Treatment Details

Interventions

• Enhanced Recovery After Surgery (ERAS)

Trial Overview The study tests if patients can safely recover at home taking oral antibiotics for three days after surgery instead of staying in the hospital. It measures how well patients stick to this plan and tracks any infections or readmissions.

Participant Groups

Group I: ERAS Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

References

1. China pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of the effects of the perioperative enhanced recovery after surgery concept on the surgical treatment of acute appendicitis in children. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

Implementation of an Enhanced Recovery After Surgery (ERAS) protocol for acute complicated and uncomplicated appendicitis. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The impact of enhanced recovery after surgery on inflammatory indicators and prognosis related to complex appendicitis in children. [2023]

4. Spain pubmed.ncbi.nlm.nih.gov

ERAS programme in a Portuguese tertiary hospital: An audit of the first six months of implementation in elective colorectal surgery. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Modified Enhanced Recovery After Surgery (ERAS) Protocol Versus Non-ERAS Protocol in Patients Undergoing Emergency Laparotomy for Acute Intestinal Obstruction: A Randomized Controlled Trial. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Results of a colorectal enhanced recovery after surgery (ERAS) programme and a qualitative analysis of healthcare workers' perspectives. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Enhanced Recovery After Surgery: Recent Developments in Colorectal Surgery. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Prospective study of enhanced recovery after surgery protocol in children undergoing reconstructive operations. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Meta-analysis of Enhanced Recovery After Surgery (ERAS) Protocols in Emergency Abdominal Surgery. [2020]