Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04861974 |
| Other study ID # |
Robocostes |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2021 |
| Est. completion date |
June 15, 2022 |
Study information
| Verified date |
April 2021 |
| Source |
Hospital del Mar |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
this is a prospective no randomized study of cost effectiveness of laparoscopic vs robotic
study of Distal pancreatectomy, Hernioplasty for inguinal hernia and Rectal resection
Description:
Robotic is having increased interest in the last decade and on of its limits is the cost.
From previous report Robotic surgery entails higher costs. However, cost solely is not enough
to validate a new procedure. Whenever a new technology is introduced it is important to
evaluate cost and improved quality of life as well, which is the Cost Effectiveness (CE)
study.
The aim of our study is to evaluate in Spain the CE of laparoscopic and robotic procedure of
Distal Pancreatectomy, Gastrectomy, Nissen procedure, Rectal resection and Inguinal hernia
repair.
This is a prospective snapshot study during 6 months in which patients are included from
several Spanish centers. Cost are defined according to the spain official cost data recorded
from the RECH (https://www.rechosp.org).
Main clinical outcomes are gathered divided in intra operative and post operative data.
Quality of life (EQ 5D-5L) is recorded as well pre operatively and post operatively at 30
days and 9 days from the surgery, time in which the follow up is ended.
A cost effectiveness analysis is finally performed:
A model-based cost-utility analysis estimating mean costs and QALYs per patient was
performed.
The Institute for Validation of Clinical Efficacy (IVEC) of the HM Hospitals group was
responsible for capturing costs ascribed to each patient's treatment. The total direct
hospital costs of care, with the exception of the acquisition or maintenance of the robotic
device.
Materials and medicines used during surgery were standardized so that the same materials were
used in all patients undergoing surgery regardless of the technique employed (Robotic or
Laparoscopic). Operative costs included the cost of the operating room in relation to the
operative time, and all required supplies (including all laparoscopic devices, sutures, and
instruments), anaesthesia, laboratory and related blood transfusion costs when required.
Hospitalization costs included costs associated with room and board, the length of hospital
stay (including intensive care, medications, blood transfusion, parenteral nutrition and
radiology charge) and costs for surgical visits (programmed and emergency) as well as
readmission costs up to 90 days from surgery. The direct costs of the professionals involved
have not been calculated as they did not vary between the two types of operation. A discount
rate of 3% per year is used in the estimation of the costs and QALYs, as recommended by
health economic guidelines (9) All costs are presented in Euros (exchange rate 2021).
Stochastic cost-utility analysis was undertaken, whereby the incremental cost-effectiveness
ratio (ICER) was estimated using overall costs of the RRR and LRR procedures and QALYs
derived from patient interviews, in order to find the incremental cost per QALYs gained.
Net monetary benefits (NMBs) were calculated in order to estimate the maximum willingness to
pay (WTP) of decision makers for a QALY gained. The NMB was calculated as the mean QALYs per
patient multiplied by WTP threshold minus the mean cost per patient for the treatment. The
decision rule is to adopt the treatment if the NMB > 0, and the alternative with the highest
NMB represents best value for money.
Sensitivity analysis A sensitivity analysis was carried out in order to propagate the
uncertainty of the estimations to the results of the model. We used a multivariate and
stochastic sensitivity analysis performed by 5,000 Monte Carlo simulations. The
cost-effectiveness plane was used to represent all pairs of solutions of the model.
The results of the one-way sensitivity analysis are shown in the tornado diagram which
depicts graphically how variations in each input affect the outcome. The 95% confidence
intervals around the base case values were derived using the 2.5 and 97.5 percentiles
calculated from the sensitivity analysis.
The tornado diagram is stacked in order of decreasing width, indicating that variations in
inputs near the top (Total Costs Robotic) have the greatest effect on the outcome, while
variations in inputs near the bottom (QALYs discount rate) have relatively small effects on
the outcome.
Acceptability curve The investigators also computed a cost-effectiveness acceptability curve
which plots the probability that the Robotic was cost-effective relative to Laparoscopy over
a reasonable range of levels of willingness-to-pay.
Although in Spain there is no specific willing to pay threshold in healthcare, according to
the National Institute for Health Care Excellence (NICE), the investigators used a
willingness-to-pay of 20,000 € and 30,000 € per QALY as a threshold to recognize which
treatment was most cost-effective
Statistics Data have been recorded in a SPSS Statistics Version 20.0 database and are
expressed as median values (interquartile range-IQR 25-75). Categorical data are presented as
numbers (%). To compare the means of the quantitative variables when the variables followed a
normal distribution, a variance analysis and a Student's t-test were used. For the rest of
the variables, both Mann-Whitney and Kruskal-Wallis tests were performed. Cost, QALYs and
incremental results are presented in a 95% Confidence Interval. A p value < .05 was
considered significant. Data herein reported are for patients who reached a minimum of one
year of follow up.
