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Completed

NCT Number: NCT03989739

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Da Vinci

Device

Primary outcomes

  1. Quality-adjusted life years

    Time frame: 2014-2018

    Quality-adjusted life years

  2. ICER

    Time frame: 2014-2018

    Incremental Cost-effectiveness Ratio

  3. Costs

    Time frame: 2014-2018

    Direct costs

Sponsors and collaborators

Lead sponsor

Fundación de investigación HM

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2018
First posted
Jun 18, 2019
Registry last updated
Jun 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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