Laparoscopic Versus Open Appendectomy? Let the Patient Decide (NCT01738750) | Clinical Trial Compass
CompletedNot Applicable
Laparoscopic Versus Open Appendectomy? Let the Patient Decide
United States100 participantsStarted 2012-07
Plain-language summary
This protocol examines choice where it pertains to choosing between two standard methods for appendectomy, laparoscopic or open procedures, and the affect that "cost" of the appendectomy has upon choice.
Children admitted with a diagnosis of uncomplicated appendicitis will be consented to participate in a study in which the patient can choose between laparoscopic or open appendectomy procedures. Those that agree to review a consent form will be randomly placed into one of two groups. The two groups consist of one in which the consent form includes "cost information for each operative procedure" in the comparison between the procedures, and the other group receives a consent form that does not include "cost information for each operative procedure". Both groups also view a short, group specific, computerized presentation that describes each procedure.
The hypothesis is that those patients given a choice between two similar surgical procedures and are provided with "cost information" will more often choose the less expensive surgical procedure than those that do not have information related to the cost of the surgical procedures.
Who can participate
Age range
17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* acute appendicitis
Exclusion Criteria:
* age 18 or older
* imaging positive for perforation; ultrasound or CT scan
* pain for greater than 2 days
* children with a body mass index \> 95% for age and sex
* surgeon decision for non-equivalent procedure based on patient presentation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was about letting patients choose between laparoscopic and open appendectomy based on cost — can you walk me through what the actual cost difference looks like for my situation, including insurance coverage and any out-of-pocket expenses for each approach?
2Since this study focused on cost as the deciding factor, what are the clinical trade-offs between laparoscopic and open appendectomy that I should weigh alongside the cost, such as recovery time, complication rates, and return to normal activity?
3This trial has already been completed — do you know if the results showed that patients who chose based on cost were satisfied with their outcomes, and would that information change what you'd recommend for me?
4Given that this was a study comparing two established surgical options rather than testing a new treatment, is there a standard-of-care recommendation you would make for my specific case regardless of cost considerations?
5Are there factors about my individual health — like the severity of my appendicitis or any other conditions I have — that would make one surgical approach clearly safer for me, even if the other option were less expensive?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Choice Based on Cost
Timeframe: Outcome assessed prior to surgical procedure with data presented within 1 year