Postoperative Pulmonary Complications in Robotic Versus Non-robotic Laparoscopic Surgery

NCT06234774 | Completed

• 1 other identifier: LapRas
• Study Type: observational
• Target: 2,378
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Respiratory Complication

Keywords

Postoperative pulmonary complications; Laparoscopic; Robotic Surgery; Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• 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)

  Postoperative day 5

Secondary Outcomes (2)

• Hospital length of stay

  1 year

• In-hospital mortality

  1 year

Study Arms (2)

Robot-assisted surgery

Patients receiving abdominal surgical procedures with robot-assisted videolaparoscopic approach

Procedure: Robot-assisted laparoscopic surgery

Non-robotic laparoscopic surgery

Patients receiving abdominal surgical procedures with conventional (non-robotic) videolaparoscopic approach

Procedure: Conventional (non-robotic) laparoscopic surgery

Interventions

Robot-assisted laparoscopic surgery PROCEDURE

Robot-assisted surgery

Conventional (non-robotic) laparoscopic surgery PROCEDURE

Non-robotic laparoscopic surgery

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Surgical patients receiving invasive mechanical ventilation for laparoscopic or robot-assisted laparoscopic surgery

You may qualify if:

• All adult patients receiving invasive ventilation (via either an endotracheal tube or supraglottic device) during general anaesthesia for elective or non-elective surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Genova: lead
• University of Amsterdam: collaborator
• University of Vienna: collaborator

Related Publications (2)

• 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.

  PMID: 28633157 BACKGROUND

• Assessment 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.

  PMID: 33131757 BACKGROUND

MeSH Terms

Interventions

Congresses as Topic; Laparoscopy

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Lorenzo Ball, MD PhD

  University of Genova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: January 31, 2024
• Study Start: January 14, 2013
• Primary Completion: January 15, 2020
• Study Completion: January 15, 2020
• Last Updated: February 2, 2024

Record last verified: 2024-01