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Why in PACU After Prostastectomy 2016

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ClinicalTrials.gov Identifier: NCT02707614
Recruitment Status : Completed
First Posted : March 14, 2016
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Eske Kvanner Aasvang, Rigshospitalet, Denmark

Study Description
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Brief Summary:
This study aims to describe the postoperative functions of patients after undergoing open or robotic prostastectomy. Primary endpoints will focus on complications in the post-anaesthesia care unit (PACU) which prevent dischard from PACU to the general ward. This include Aldrete scores and other complications that can be registrered descriptively. Furthermore, the study seeks to compare what influence open versus robotic prostastectomy have on peri- og postoperative complications.

Condition or disease Intervention/treatment
Perioperative, Enhanced Recovery Procedure: Robotic vs open prostastectomy

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Perioperative Mechanisms for Postoperative Function - the Case of Prostastectomy
Study Start Date : February 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016
Groups and Cohorts
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Group/Cohort Intervention/treatment
Robotic vs open prostastectomy
One group is operated by open prostatectomy the other by robotic assistance
 Procedure: Robotic vs open prostastectomy
robotic minimal invasive surgery


Outcome Measures
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Primary Outcome Measures :
  1. Complications [ Time Frame: up to 7 days ]
    Complications assessed by aldrete score


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study includes male patients with prostate cancer that will undergo surgery regarding removal or staging of their prostate cancer. The stage of the disease is insignificant, however the patients preoperative physical state for surgery will be registrered in detailed such as comorbidities, height, weight, bloodpressure and blood test results.
Criteria

Inclusion Criteria:

  • Histology diagnosis of prostate cancer
  • Surgery intended for removal or staging of prostate cancer: open prostatectomy, robotic prostastectomy, open staging surgery, laparoscopic staging surgery.

Exclusion Criteria:

  • Patients with prostate cancer that do not have surgery.
  • Surgery regarding only removal of distant mestatases origined from prostate cancer.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02707614


Locations
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Denmark
Rigshospitalet, abdominal center
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Eske K Aasvang, DMSci Rigshospitalet, Denmark
More Information
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Additional Information:

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Responsible Party: Eske Kvanner Aasvang, Dr, DMSci, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02707614    
Other Study ID Numbers: PACU Prostastectomy 2016
First Posted: March 14, 2016    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided