A Cost Effectiveness Analysis of Robotic Versus Laparoscopic Distal Pancreatectomy

NCT03989739 | Completed

• 1 other identifier: Fundacionhm
• Study Type: observational
• Target: 59
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Surgery

Keywords

Cost-effectiveness; Pancreatectomy; Willingness to pay; Robotic

Outcome Measures

Primary Outcomes (3)

• Quality-adjusted life years

  Quality-adjusted life years

  2014-2018

• ICER

  Incremental Cost-effectiveness Ratio

  2014-2018

• Costs

  Direct costs

  2014-2018

Study Arms (2)

robotic distal pancreatectomy

Device: Da Vinci

laparoscopic distal pancreatectomy

Interventions

Da Vinci DEVICE

robotic distal pancreatectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Fundación de investigación HM: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 18, 2019
• Study Start: February 1, 2014
• Primary Completion: February 1, 2014
• Study Completion: December 31, 2018
• Last Updated: June 18, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share