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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up more than 7 days after index admission but within 60 days of randomization.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My appendicitis is severe with a rupture and infection shown on a CT scan.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ more than 7 days after index admission but within 60 days of randomization.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~more than 7 days after index admission but within 60 days of randomization.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of hospital days
Secondary outcome measures
Complications
Days of disability
Failed attempted procedure.
+10 moreTrial 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
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,851 Previous Clinical Trials
2,738,033 Total Patients Enrolled
1 Trials studying Appendicitis
20 Patients Enrolled for Appendicitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have tried draining fluid before being assigned to a treatment group.I am allergic to common antibiotics and need alternative treatments.I have had major surgery in my abdomen.I have not been hospitalized in the last 2 weeks.I was in septic shock when I was admitted to the hospital.I am on dialysis for sudden kidney failure.You are currently using a machine to help you breathe.My appendicitis is severe with a rupture and infection shown on a CT scan.You are pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Surgery
- Group 2: Non-operative management
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total enrollment capacity for this research project?
"Affirmative. The information provided on clinicaltrials.gov demonstrates that this investigation is currently searching for participants, with a post date of March 11th 2020 and most recent update of July 18th 2022. A total of 180 people are needed to be recruited at 1 facility."
Answered by AI
Are any new participants being sought out for this research endeavor?
"Affirmative. The clinicaltrials.gov website details that this experiment has commenced recruitment and was uploaded on March 11th, 2020 with the most recent edit being made on July 18th 2022. 180 participants are required from a single center to complete it successfully."
Answered by AI
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