Lung Function After Robot-assisted Radical Prostate Ectomy

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Lung Function

Treatments: Device: AirSeal; Device: Olympus UHI-3

Study type: Interventional

Funder types: Other

Identifiers

NCT02066246

ANA-UKE-PV4374

Details and patient eligibility

About

The aim of our study is to investigate if the use of the AirSeal insufflation system impairs the lung function of patients less than a conventional system in patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP). Therefore we examine the lung function before and after surgery.

As a second purpose of the study, in a subgroup, we investigate the influence of the gas insufflators (AirSeal and conventional) on hemodynamics during surgery. Furthermore we study the change in the lung perfusion-ventilation-ratio by using the electric impedance tomography technique.

Enrollment: 192 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for RALP
• Written informed consent
• ≥ 18 years of age

Exclusion criteria

• Age under 18 years
• Patients who refuse participating in the study
• Obstructive airway disease (COPD and Asthma)
• Postoperative admission to an intensive or intermediate care unit
• Patients who do not speak German or English

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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192 participants in 2 patient groups

Olympus UHI-3

Sham Comparator group

Description:

patients are treated with the Olympus UHI-3-CO2-insufflation and trocar system

Treatment:

Device: Olympus UHI-3

AirSeal

Active Comparator group

Description:

patients are treated with the AirSeal-CO2-insufflator and trocar-system

Treatment:

Device: AirSeal