← Back to Search

Surgery vs Non-Operative Management for Appendicitis

N/A

Recruiting

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Complicated appendicitis with presumed perforation on (computer tomography) CT scan AND phlegmon or abscess greater than 2 centimeter (cm).

Be older than 18 years old

Must not have

Attempted drainage before randomization

Antibiotic allergy requiring the use of something other than a beta-lactam or quinolone based therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days after randomization.

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare early surgery to non-operative management for people with appendicitis who also have an infection.

Who is the study for?

Adults with a specific type of appendicitis shown on CT scans, which includes a perforation and an abscess or phlegmon over 2 cm. Not eligible if they've had major abdominal surgery, recent hospitalization, septic shock at admission, need mechanical ventilation or dialysis, are pregnant, have had certain treatments prior to the trial or have specific antibiotic allergies.

What is being tested?

The study is comparing two approaches for treating complicated appendicitis: one group will undergo surgery while the other will receive non-surgical treatment with drainage or antibiotics. The goal is to see which method is more effective.

What are the potential side effects?

Surgery may lead to risks like infection, bleeding, and anesthesia complications. Non-operative management could result in ineffective treatment requiring later surgery and potential side effects from antibiotics such as allergic reactions or digestive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My appendicitis is severe with a rupture and infection shown on a CT scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have tried draining fluid before being assigned to a treatment group.

Select...

I am allergic to common antibiotics and need alternative treatments.

Select...

I have had major surgery in my abdomen.

Select...

I have not been hospitalized in the last 2 weeks.

Select...

I was in septic shock when I was admitted to the hospital.

Select...

I am on dialysis for sudden kidney failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days after randomization.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days after randomization.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after randomization. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of hospital days

Secondary study objectives

Complications

Days of disability

Failed attempted procedure.

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SurgeryExperimental Treatment1 Intervention

Patients who choose operations will have surgery performed to remove the appendix laparoscopically, through 3 or 4 small incisions. All patients in the operative group will receive standard perioperative antibiotics. They will also have the abscess(es) drained during the same surgery if there is one present. In some cases, the operation may be too difficult to perform laparoscopically, so an open appendectomy will be performed, involving a longer incision to remove the appendix. In some cases, both laparoscopic and open are performed. The surgeon may also choose to remove a section of the intestine with the appendix or perform additional procedures.

Group II: Non-operative managementActive Control1 Intervention

If a patient chooses non-operative management and if an abscess is present and amenable to percutaneous drainage this will be performed. If there is no abscess or it is not amenable to drainage antibiotics alone will be provided.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Operative management

2012

N/A

~230

0 / 7Eligibility criteria met