Trial Outcomes & Findings for Laparoscopic Versus Open Appendectomy? Let the Patient Decide (NCT NCT01738750)

NCT ID: NCT01738750

Last Updated: 2014-05-19

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: Outcome assessed prior to surgical procedure with data presented within 1 year
• Results posted on: 2014-05-19

Participant Flow

Participant milestones

Measure	Cost Information Included Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure. Cost Information Included	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.
Overall Study STARTED	49	51
Overall Study COMPLETED	49	51
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Laparoscopic Versus Open Appendectomy? Let the Patient Decide

Baseline characteristics by cohort

Measure	Cost Information Included n=49 Participants Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure. Cost Information Included	No Cost Information Included n=51 Participants Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.	Total n=100 Participants Total of all reporting groups
Age, Continuous	10.8 years STANDARD_DEVIATION 3.3 • n=5 Participants	10.6 years STANDARD_DEVIATION 3.2 • n=7 Participants	10.7 years STANDARD_DEVIATION 3.2 • n=5 Participants
Age, Categorical <=18 years	49 Participants n=5 Participants	51 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	31 Participants n=7 Participants	58 Participants n=5 Participants
Region of Enrollment United States	49 participants n=5 Participants	51 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Cost Information Included n=49 Participants Percentage of Participants who Choose Open Appendectomy or Laparoscopic Appendectomy	No Cost Information Included n=51 Participants Percentage of Participants who Choose Open Appendectomy or Laparoscopic Appendectomy
Choice Based on Cost	63 percentage of open appendectomy	35 percentage of open appendectomy

SECONDARY outcome

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

A comparison of the overall hospital admission and operative dollars for acute appendicitis and appendectomy between the two groups

Outcome measures

Measure	Cost Information Included n=49 Participants Percentage of Participants who Choose Open Appendectomy or Laparoscopic Appendectomy	No Cost Information Included n=51 Participants Percentage of Participants who Choose Open Appendectomy or Laparoscopic Appendectomy
Hospital/Operative Dollars	9,949 Dollar	10,477 Dollar

Adverse Events

Cost Information Included

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Cost Information Included

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Eric Scaife

University of Utah

Phone: 801-662-2950

Email: eric.scaife@imail2.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place