Lung Function After Robot-assisted Radical Prostate Ectomy

NCT ID: NCT02066246

Last Updated: 2014-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Olympus UHI-3

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

Group Type SHAM_COMPARATOR

Olympus UHI-3

Intervention Type DEVICE

100 patients are treated with a conventional insufflation and trocar system

AirSeal

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

Group Type ACTIVE_COMPARATOR

AirSeal

Intervention Type DEVICE

100 patients are treated with the AirSeal insufflation and trocar system

Interventions

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AirSeal

100 patients are treated with the AirSeal insufflation and trocar system

Intervention Type DEVICE

Olympus UHI-3

100 patients are treated with a conventional insufflation and trocar system

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Prostate Center North West Department of Urology and Pediatric Urology

UNKNOWN

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel A Reuter, PhD MD

Role: STUDY_DIRECTOR

Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg

Alexander März, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg

Günter Lippert, MD

Role: PRINCIPAL_INVESTIGATOR

Prostate Cancer Center North West, at St. Antonius-Hospital, Gronau, Germany .

Alexander Haese, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Martini Clinic, Prostate Cancer Center, University Hospital Hamburg-Eppendorf, Hamburg, Germany.

Jörn Witt, MD

Role: PRINCIPAL_INVESTIGATOR

Prostate Cancer Center North West, at St. Antonius-Hospital, Gronau, Germany

Locations

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Prostate Cancer Center Northwest, at St. Antonius Hospital Gronau

Gronau, , Germany

Site Status

Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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ANA-UKE-PV4374

Identifier Type: -

Identifier Source: org_study_id

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