A Cost Effectiveness Analysis of Robotic Versus Laparoscopic Distal Pancreatectomy

Surgery Clinical Trial

Official title:

A Cost Effectiveness Analysis of Robotic Versus Laparoscopic Distal Pancreatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03989739
• Other study ID #: Fundacionhm
• Status: Completed
• Start date: February 1, 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2019
• Source: Fundación de investigación HM
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 31, 2018
• Est. primary completion date: February 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Surgery

Intervention

Device:
• Da Vinci

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundación de investigación HM

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality-adjusted life years	Quality-adjusted life years	2014-2018
Primary	ICER	Incremental Cost-effectiveness Ratio	2014-2018
Primary	Costs	Direct costs	2014-2018