Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06234774
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2023-12-11
Brief Title:
Postoperative Pulmonary Complications in Robotic Versus Non-robotic Laparoscopic Surgery
Sponsor:
University of Genova
Organization:
University of Genova
Study Overview
Official Title:
Risk Factors for PPCs in Laparoscopic Non-Robotic vs Laparoscopic Robotic Abdominal Surgery LapRas- a Patient-Level Analysis of LAS VEGAS and AVATaR
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LapRas
Brief Summary:
This secondary analysis aims to identify factors associated with the development of postoperative pulmonary complications PPCs in patients undergoing abdominal surgery pooling and analyzing the data of two worldwide prospective studies the Epidemiology Practice of Ventilation and Outcome for Patients at Increased Risk of Postoperative Pulmonary Complications LAS VEGAS NCT01601223 and the Assessment of Ventilatory management during general AnesThesia for Robotic surgery and its effects on postoperative pulmonary complications AVATaR NCT02989415
The primary aim is to compare the incidence of PPCs between patients undergoing non-robotic surgery versus patients undergoing robot-assisted surgery One secondary aim is to determine which factors are associated with the occurrence of PPCs The investigators hypothesize that differences in the occurrence of PPCs between the two surgery groups are more driven by differences in duration of anesthesia than by the intensity of ventilation
The primary aim is to compare the incidence of PPCs between patients undergoing non-robotic surgery versus patients undergoing robot-assisted surgery One secondary aim is to determine which factors are associated with the occurrence of PPCs The investigators hypothesize that differences in the occurrence of PPCs between the two surgery groups are more driven by differences in duration of anesthesia than by the intensity of ventilation
Detailed Description:
This study involves a preplanned analysis of a merged database comprising individual patient data from two global observational studies on ventilation and postoperative pulmonary complications PPCs Both study protocols the LAS VEGAS and AVATaR were approved by a central Institutional Review Board and local ethics committees with written informed consent obtained as per local legislation The pooled database including modifications for patient categories does not require additional ethical approval or informed consent The analysis will adhere to the Strengthening the Reporting of Observational Studies in Epidemiology STROBE Statement
Patients
The LAS VEGAS study includes patients undergoing general anesthesia with invasive ventilation for elective and non-elective surgeries
The AVATaR study includes patients aged over 18 undergoing robot-assisted surgery RAS for abdominal procedures
Baseline Patient Characteristics
- Key variables extracted from LAS VEGAS and AVATaR include demographic data smoking status comorbidities chronic heart disease obstructed sleep apnea syndrome anemia chronic kidney disease and details about anesthesia and surgery
Ventilation Variables
Ventilation-related variables extracted from the database include inspiratory pressure plateau pressure positive end-expiratory pressure tidal volume respiratory rate fraction of inspired oxygen peripheral oxygen saturation end-tidal carbon dioxide
Mode of ventilation is classified as volume-controlled pressure-controlled including volume-guarantee pressure-controlled and others
Intensity of mechanical ventilation will be studied by three different estimators the driving pressure driving pressure multiplied by four plus respiratory rate and mechanical power
For the statistical analysis medians with interquartile ranges or as number with percentages will be used as appropriate Differences between the two groups of patients will be analyzes by Fisher or Wilcoxon test as appropriate Key variables will be plotted by the cumulative distribution plots
Numbers of available patients who meet inclusion criteria will represent our cohort of patients The investigators estimated a 10 of drop off for additional exclusion criteria For this reason the enrollment of patients cannot be actual but just anticipated The main analysis will be an univariable followed by a multivariable model including known risk factors for PPCs intensity of ventilation and group laparoscopic versus robotic surgery covariates will be entered in the model Logistic regression analysis will be performed for studying the association between PPCs and intensity of ventilation and duration of anesthesia In case of relevant co-linearity of independent variables separate models will be built excluding co-linear variables and the performances of the different models will be assessed using the corrected Akaike information criterion In case of an association between RAS and PPCs a mediation analysis to investigate the relationship between PPC and surgical approach will be conducted In addition a matched-cohort analysis in patients with similar length of mechanical ventilation and intensity of ventilation will be performed The mediation analysis will be reported according to the A Guideline for Reporting Mediation Analyses AGReMA statement R Project for Statistical Computing will be used for analyzing data
The analysis aims to compare incidences of PPCs after laparoscopic non-robotic and RAS abdominal surgeries exploring associations with patient surgery and anesthesia factors
Patients
The LAS VEGAS study includes patients undergoing general anesthesia with invasive ventilation for elective and non-elective surgeries
The AVATaR study includes patients aged over 18 undergoing robot-assisted surgery RAS for abdominal procedures
Baseline Patient Characteristics
- Key variables extracted from LAS VEGAS and AVATaR include demographic data smoking status comorbidities chronic heart disease obstructed sleep apnea syndrome anemia chronic kidney disease and details about anesthesia and surgery
Ventilation Variables
Ventilation-related variables extracted from the database include inspiratory pressure plateau pressure positive end-expiratory pressure tidal volume respiratory rate fraction of inspired oxygen peripheral oxygen saturation end-tidal carbon dioxide
Mode of ventilation is classified as volume-controlled pressure-controlled including volume-guarantee pressure-controlled and others
Intensity of mechanical ventilation will be studied by three different estimators the driving pressure driving pressure multiplied by four plus respiratory rate and mechanical power
For the statistical analysis medians with interquartile ranges or as number with percentages will be used as appropriate Differences between the two groups of patients will be analyzes by Fisher or Wilcoxon test as appropriate Key variables will be plotted by the cumulative distribution plots
Numbers of available patients who meet inclusion criteria will represent our cohort of patients The investigators estimated a 10 of drop off for additional exclusion criteria For this reason the enrollment of patients cannot be actual but just anticipated The main analysis will be an univariable followed by a multivariable model including known risk factors for PPCs intensity of ventilation and group laparoscopic versus robotic surgery covariates will be entered in the model Logistic regression analysis will be performed for studying the association between PPCs and intensity of ventilation and duration of anesthesia In case of relevant co-linearity of independent variables separate models will be built excluding co-linear variables and the performances of the different models will be assessed using the corrected Akaike information criterion In case of an association between RAS and PPCs a mediation analysis to investigate the relationship between PPC and surgical approach will be conducted In addition a matched-cohort analysis in patients with similar length of mechanical ventilation and intensity of ventilation will be performed The mediation analysis will be reported according to the A Guideline for Reporting Mediation Analyses AGReMA statement R Project for Statistical Computing will be used for analyzing data
The analysis aims to compare incidences of PPCs after laparoscopic non-robotic and RAS abdominal surgeries exploring associations with patient surgery and anesthesia factors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None