Postoperative Respiratory ComplicationLapRasNCT06234774
Postoperative Pulmonary Complications in Robotic Versus Non-robotic Laparoscopic Surgery
An observational study of Postoperative Respiratory Complication, run by University of Genova.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Postoperative Respiratory Complication
- What is being tested?
- Robot-assisted laparoscopic surgery and Conventional (non-robotic) laparoscopic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 2,378 participants
- Where
- No sites listed yet
- Study dates
- 14 Jan 2013to 15 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surgical patients receiving invasive mechanical ventilation for laparoscopic or robot-assisted laparoscopic surgery
Who may be able to join
- All adult patients receiving invasive ventilation (via either an endotracheal tube or supraglottic device) during general anaesthesia for elective or non-elective surgery.
Who cannot join
- patients not undergoing laparoscopic surgery in LAS VEGAS, and not undergoing abdominal RAS in AVATaR;
- patients undergoing combined thoracic-laparoscopic surgery and patients in whom the intervention was converted from laparoscopic or RAS to open surgery are excluded;
- patients that received recent ventilation before surgery;
- patients with incomplete ventilation datasets not allowing the computation of intensity of ventilation, and patients with an incomplete follow-up for PPCs are also excluded.
About this study
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
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.
Read the 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.
- Conditions
- Postoperative Respiratory Complication
- Being tested
- Robot-assisted laparoscopic surgery, Conventional (non-robotic) laparoscopic surgery
- Keywords
- Postoperative pulmonary complications, Laparoscopic, Robotic Surgery, Mechanical Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted laparoscopic surgeryProcedure or surgery
Conventional (non-robotic) laparoscopic surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted surgery | Patients receiving abdominal surgical procedures with robot-assisted videolaparoscopic approach Receives: Procedure: Robot-assisted laparoscopic surgery | |
| Non-robotic laparoscopic surgery | Patients receiving abdominal surgical procedures with conventional (non-robotic) videolaparoscopic approach Receives: Procedure: Conventional (non-robotic) laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pulmonary complications
Composite end-point of post-operative pulmonary complications (new onset of acute respiratory distress syndrome (ARDS), pneumonia, pneumothorax, acute respiratory failure, need of oxygen therapy, need for postoperative invasive or non-invasive mechanical ventilation)
Measured: Postoperative day 5
Secondary outcomes (2)
Hospital length of stay
Days elapsed from surgery to discharge from hospital
Measured: 1 year
In-hospital mortality
Death event occurring in the hospital after surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start14 Jan 2013
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Respiratory ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,378 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Genova
- Sponsor type
- University, hospital or other
- Collaborators
- University of Amsterdam, University of Vienna
- Responsible party
- Principal investigator, Lorenzo Ball, University of Genova
- Investigators
- Lorenzo Ball, MD PhD, Principal investigator, University of Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234774
- Sponsor's protocol ID
- LapRas
- Acronym
- LapRas
- Status last verified
- Jan 2024
- First submitted
- 11 Dec 2023
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
LAS VEGAS investigators. Epidemiology, practice of ventilation and outcome for patients at increased risk of postoperative pulmonary complications: LAS VEGAS - an observational study in 29 countries. Eur J Anaesthesiol. 2017 Aug;34(8):492-507. doi: 10.1097/EJA.0000000000000646.
PubMed 28633157Assessment of Ventilation during general AnesThesia for Robotic surgery (AVATaR) Study Investigators; PROtective VEntilation (PROVE) Network; Writing Committee Members; Steering Committee Members; AVATaR Investigators. Ventilation and outcomes following robotic-assisted abdominal surgery: an international, multicentre observational study. Br J Anaesth. 2021 Feb;126(2):533-543. doi: 10.1016/j.bja.2020.08.058. Epub 2020 Oct 31.
PubMed 33131757
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06234774
- Acronym / sponsor ID
- LapRas / LapRas
- Conditions
- Postoperative Respiratory Complication
- Keywords
- Postoperative pulmonary complications, Laparoscopic, Robotic Surgery, Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,378 participants (actual)
- Lead sponsor
- University of GenovaUniversity, hospital or other
- Collaborators
- University of Amsterdam, University of Vienna
- Study start
- 14 Jan 2013 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted surgery | – | Procedure: Robot-assisted laparoscopic surgeryPatients receiving abdominal surgical procedures with robot-assisted videolaparoscopic approach |
| Non-robotic laparoscopic surgery | – | Procedure: Conventional (non-robotic) laparoscopic surgeryPatients receiving abdominal surgical procedures with conventional (non-robotic) videolaparoscopic approach |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical patients receiving invasive mechanical ventilation for laparoscopic or robot-assisted laparoscopic surgery
Key inclusion criteria (1 listed)
- All adult patients receiving invasive ventilation (via either an endotracheal tube or supraglottic device) during general anaesthesia for elective or non-elective surgery.
Key exclusion criteria (4 listed)
- patients not undergoing laparoscopic surgery in LAS VEGAS, and not undergoing abdominal RAS in AVATaR;
- patients undergoing combined thoracic-laparoscopic surgery and patients in whom the intervention was converted from laparoscopic or RAS to open surgery are excluded;
- patients that received recent ventilation before surgery;
- patients with incomplete ventilation datasets not allowing the computation of intensity of ventilation, and patients with an incomplete follow-up for PPCs are also excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-assisted laparoscopic surgery | Procedure or surgery | Robot-assisted surgery |
| Conventional (non-robotic) laparoscopic surgery | Procedure or surgery | Non-robotic laparoscopic surgery |
Primary outcome
Postoperative pulmonary complications
Time frame: Postoperative day 5
Composite end-point of post-operative pulmonary complications (new onset of acute respiratory distress syndrome (ARDS), pneumonia, pneumothorax, acute respiratory failure, need of oxygen therapy, need for postoperative invasive or non-invasive mechanical ventilation)
2 secondary outcomes
Hospital length of stay
Time frame: 1 year
In-hospital mortality
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Background: PubMed 28633157LAS VEGAS investigators. Epidemiology, practice of ventilation and outcome for patients at increased risk of postoperative pulmonary complications: LAS VEGAS - an observational study in 29 countries. Eur J Anaesthesiol. 2017 Aug;34(8):492-507. doi: 10.1097/EJA.0000000000000646.
- Background: PubMed 33131757Assessment of Ventilation during general AnesThesia for Robotic surgery (AVATaR) Study Investigators; PROtective VEntilation (PROVE) Network; Writing Committee Members; Steering Committee Members; AVATaR Investigators. Ventilation and outcomes following robotic-assisted abdominal surgery: an international, multicentre observational study. Br J Anaesth. 2021 Feb;126(2):533-543. doi: 10.1016/j.bja.2020.08.058. Epub 2020 Oct 31.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenzo Ball, MD PhD principal investigator
University of Genova
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Respiratory Complication, run by University of Genova.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pulmonary complications (time frame: Postoperative day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06234774, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.