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A Cost Effectiveness Analysis of Robotic Versus Laparoscopic Distal Pancreatectomy

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ClinicalTrials.gov Identifier: NCT03989739
Recruitment Status : Completed
First Posted : June 18, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Fundación de investigación HM

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.

Condition or disease Intervention/treatment
Surgery Device: Da Vinci

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Study Type : Observational
Actual Enrollment : 59 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Cost Effectiveness Analysis of Robotic Versus Laparoscopic Distal Pancreatectomy
Actual Study Start Date : February 1, 2014
Actual Primary Completion Date : February 1, 2014
Actual Study Completion Date : December 31, 2018

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



Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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:

-


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Responsible Party: Fundación de investigación HM
ClinicalTrials.gov Identifier: NCT03989739     History of Changes
Other Study ID Numbers: Fundacionhm
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación de investigación HM:
Cost-effectiveness
Pancreatectomy
Willingness to pay
Robotic