A Cost Effectiveness Analysis of Robotic Versus Laparoscopic Distal Pancreatectomy

This is a clinical and cost-effectiveness analysis within a retrospective comparative study of RDP and LDP conducted at Sanchinarro University Hospital from 2011 to 2017. Outcome parameters included surgical and post-operative costs, quality adjusted life years (QALY), and incremental cost per QALY gained or the incremental cost effectiveness ratio (ICER). A sensitivity analysis was carried out in order to propagate the uncertainty of the estimations to the results of the model. The investigators use a multivariate and stochastic sensitivity analysis performed by 5000 Monte Carlo simulations. The cost-effectiveness plane was used to represent all pairs of solutions of the model.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Device: Da Vinci

• Study Type: Observational
• Enrollment (Actual): 59

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study was carried out at the General Surgery Department of Sanchinarro University Hospital of Madrid.

Details of the procedure have been described in a previous report and standardized in both groups. RDP was performed using a da Vinci Robotic Surgical System model Si and Xi (Intuitive Surgical, Sunnyvale, CA, USA) (8). All consecutive cases were conducted by the same group of 6 surgeons all with considerable experience in both laparoscopic and robotic approaches.

Patients (aged over 18 years) with benign or malignant mass without evidence of major vessel involvement were included and assigned either to RDP or LDP, depending on the availability of the robot. The indication for resection was given in the context of a multidisciplinary institutional committee.

Description

Inclusion Criteria:

• Patients (aged over 18 years) with benign or malignant mass without evidence of major vessel involvement were included.
• The indication for resection was given in the context of a multidisciplinary institutional committee

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
robotic distal pancreatectomy	Device: Da Vinci
laparoscopic distal pancreatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality-adjusted life years	Quality-adjusted life years	2014-2018
ICER	Incremental Cost-effectiveness Ratio	2014-2018
Costs	Direct costs	2014-2018

Collaborators and Investigators

• Sponsor: Fundación de investigación HM

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: June 14, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (Actual): June 18, 2019

Study Record Updates

• Last Update Posted (Actual): June 18, 2019
• Last Update Submitted That Met QC Criteria: June 17, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Pancreatectomy; Cost-effectiveness; Robotic; Willingness to pay
• Other Study ID Numbers: Fundacionhm

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No