Laparoscopic Versus Open Appendectomy? Let the Patient Decide

NCT ID: NCT01738750

Last Updated: 2014-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-12-31

Brief 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.

Conditions

Appendicitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Cost Information Included

Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.

Group Type: EXPERIMENTAL

Cost Information Included

Intervention Type: OTHER

No Cost Information Included

Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cost Information Included

Intervention Type: OTHER

Eligibility Criteria

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

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Scaife, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

Primary Children's Hospital

Salt Lake City, Utah, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25185471 (View on PubMed)

Other Identifiers

UU56320

Identifier Type: -

Identifier Source: org_study_id