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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether patients can safely go home with only oral antibiotics for three days after appendix removal due to complicated appendicitis. Researchers aim to determine if patients adhere to the recovery plan and if this approach prevents infections or hospital readmissions. The study seeks adults who have undergone appendix removal using laparoscopic surgery and have been diagnosed with complicated appendicitis, such as a small hole or severe swelling. This method is part of the Enhanced Recovery After Surgery (ERAS) program, which focuses on improving patient outcomes and speeding up recovery. As an unphased trial, it offers patients the chance to contribute to innovative recovery methods that could enhance future surgical care.

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 prior data suggests that this enhanced recovery protocol is safe for patients with complicated appendicitis?

Research has shown that Enhanced Recovery After Surgery (ERAS) can help individuals recover faster following appendicitis surgery. Studies have found these methods to be safe, enabling patients to resume normal activities more quickly. One study found that ERAS can safely reduce hospital stays without increasing the risk of complications. Another study showed that patients following an ERAS plan after a laparoscopic appendectomy experienced good outcomes and fewer hospital readmissions.

Overall, ERAS plans are generally easy for patients to follow, with serious side effects being rare. Most patients do well, with only a few needing to return to the hospital. This suggests that ERAS is a safe option for many people to consider after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Enhanced Recovery After Surgery (ERAS) for appendicitis because it aims to optimize surgical recovery. Unlike traditional approaches that often involve longer hospital stays and more extensive use of pain medication, ERAS focuses on evidence-based strategies to speed up recovery, such as early mobilization, tailored pain management, and optimized nutrition. This protocol could lead to faster discharge, reduced complications, and improved overall patient satisfaction.

What evidence suggests that this enhanced recovery protocol is effective for appendicitis?

Research shows that Enhanced Recovery After Surgery (ERAS) plans can help patients recover faster after a laparoscopic appendectomy for acute appendicitis. Studies have found that ERAS reduces complications and shortens hospital stays. Patients following ERAS plans recover more quickly and experience fewer problems after surgery. This trial will evaluate ERAS for patients with complicated appendicitis, aiming to determine if it leads to a faster and safer recovery in these more severe cases. ^{1 2 3 4 6}

Who Is on the Research Team?

Galinos Barmparas, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10989332/

Clinical study of enhanced recovery after surgery in ... This study found that ERAS could accelerate the recovery of patients who underwent laparoscopic appendectomy due to acute appendicitis.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06948071?term=AREA%5BConditionSearch%5D(%22Cecal%20Diseases%22)&rank=8

Enhanced Recovery After Surgery (ERAS) for Complicated ... 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 ...

3. nature.com nature.com/articles/s41598-020-67591-5

Evaluation of enhanced recovery after surgery program ... This randomized controlled trial was conducted to evaluate the safety, effectiveness and feasibility of a modified ERAS protocol in patients undergoing LA.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38577072/

Clinical study of enhanced recovery after surgery in ... Conclusion: ERAS could significantly accelerate the recovery of patients who underwent laparoscopic appendectomy for acute appendicitis, shorten ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820097

Enhanced Recovery After Surgery Guidelines and Hospital ... ERAS guidelines provide recommendations for perioperative care and have been found to reduce complications, length of hospital stay, and cost.

6. wjes.biomedcentral.com wjes.biomedcentral.com/articles/10.1186/s13017-022-00465-5

Outpatient management of acute uncomplicated appendicitis ... Objective. To confirm the safety and efficacy of outpatient management of laparoscopic appendectomy, with an enhanced recovery after surgery ...