AppendicitisNCT01738750
Laparoscopic Versus Open Appendectomy? Let the Patient Decide
A study testing Cost Information Included in people with Appendicitis, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- Cost Information Included
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- acute appendicitis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Primary Children's Hospital
Salt Lake City, Utah, 84113
About this study
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.
- Conditions
- Appendicitis
- Being tested
- Cost Information Included
- Keywords
- surgical choice, cost of care, decision making, health care, health care cost, pediatric, children, appendicitis, patient satisfaction
- Medical subject headings
- Appendicitis, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cost Information IncludedOther
| Study group | Role | What they receive |
|---|---|---|
| Cost Information Included | Experimental | Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure. Receives: Other: Cost Information Included |
| No Cost Information Included | No intervention | Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choice Based on Cost
The group given information related to the cost of each surgical procedure will more often choose the less expensive procedure as compared to those not given cost information
Measured: Outcome assessed prior to surgical procedure with data presented within 1 year
Secondary outcomes (1)
Hospital/Operative Dollars
A comparison of the overall hospital admission and operative dollars for acute appendicitis and appendectomy between the two groups
Measured: Data will be collected within an expected average of 3 months post-discharge with data presented within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Scaife, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738750
- Sponsor's protocol ID
- UU56320
- Status last verified
- Apr 2014
- First submitted
- 22 Nov 2012
- Last updated
- 19 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Russell KW, Rollins MD, Barnhart DC, Mone MC, Meyers RL, Skarda DE, Soukup ES, Black RE, Molitor MS, Stoddard GJ, Scaife ER. Charge Awareness Affects Treatment Choice: Prospective Randomized Trial in Pediatric Appendectomy. Ann Surg. 2015 Jul;262(1):189-93. doi: 10.1097/SLA.0000000000000885.
PubMed 25185471
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Open Appendectomy? Let the Patient Decide
- ClinicalTrials.gov ID
- NCT01738750
- Acronym / sponsor ID
- UU56320
- Conditions
- Appendicitis
- Keywords
- surgical choice, cost of care, decision making, health care, health care cost, pediatric, children, appendicitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Posted 19 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cost Information Included | Experimental | Other: Cost Information IncludedGroup of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure. |
| No Cost Information Included | No intervention | –Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- acute appendicitis
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cost Information Included | Other | Cost Information Included |
Primary outcome
Choice Based on Cost
Time frame: Outcome assessed prior to surgical procedure with data presented within 1 year
The group given information related to the cost of each surgical procedure will more often choose the less expensive procedure as compared to those not given cost information
1 secondary outcome
Hospital/Operative Dollars
Time frame: Data will be collected within an expected average of 3 months post-discharge with data presented within 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25185471Russell KW, Rollins MD, Barnhart DC, Mone MC, Meyers RL, Skarda DE, Soukup ES, Black RE, Molitor MS, Stoddard GJ, Scaife ER. Charge Awareness Affects Treatment Choice: Prospective Randomized Trial in Pediatric Appendectomy. Ann Surg. 2015 Jul;262(1):189-93. doi: 10.1097/SLA.0000000000000885.
Related trials for Appendicitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Scaife, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cost Information Included in people with Appendicitis, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Choice Based on Cost (time frame: Outcome assessed prior to surgical procedure with data presented within 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01738750, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2014.