Laparoscopic Versus Open Appendectomy? Let the Patient Decide

NCT01738750 | Completed Results

• 1 other identifier: UU56320
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

surgical choice; cost of care; decision making; health care; health care cost; pediatric; children; appendicitis; patient satisfaction

Outcome Measures

Primary Outcomes (1)

• 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

  Outcome assessed prior to surgical procedure with data presented within 1 year

Secondary Outcomes (1)

• Hospital/Operative Dollars

  Data will be collected within an expected average of 3 months post-discharge with data presented within 1 year

Study Arms (2)

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.

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.

Interventions

Cost Information Included OTHER

Cost Information Included

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• acute appendicitis

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

Related Publications (1)

• 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.

  PMID: 25185471 DERIVED

MeSH Terms

Conditions

Appendicitis; Patient Satisfaction

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Dr. Eric Scaife
• Organization: University of Utah

eric.scaife@imail2.org

801-662-2950

Study Officials

• Eric Scaife, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2012
• First Posted: November 30, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 19, 2014
• Results First Posted: May 19, 2014

Record last verified: 2014-04

Locations

US (1)