Why in PACU After Prostastectomy 2016

April 25, 2017 updated by: Eske Kvanner Aasvang, Rigshospitalet, Denmark

Perioperative Mechanisms for Postoperative Function - the Case of Prostastectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet, abdominal center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: up to 7 days
Complications assessed by aldrete score
up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Eske K Aasvang, DMSci, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

March 1, 2016

First Submitted That Met QC Criteria

March 8, 2016

First Posted (Estimate)

March 14, 2016

Study Record Updates

Last Update Posted (Actual)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • PACU Prostastectomy 2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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