- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00695773
Laparoscopic Vs. Open Prostatectomy Outcomes
November 28, 2008 updated by: Lahey Clinic
This study is aimed at discovering the differences in outcomes, regarding quality of life issues(continence, impotence) of patients who have had either laparoscopic or open surgical technique for prostate cancer.
Study Overview
Status
Terminated
Conditions
Detailed Description
This study is a post surgical, data collection effort in order to gather definitive, Quality of Life(continence, impotence) information regarding the outcomes of patients who have undergone either Laparoscopic vs. Prostatectomy surgeries for Prostate Cancer.
As part of the study, 200 subject's medical records will be retrospectively reviewed and 100 current subjects will be prospectively contacted.
The information collected may benefit patients who undergo a prostatectomy
Study Type
Observational
Enrollment (Actual)
158
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
-
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Massachusetts
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Burlington, Massachusetts, United States, 01805
- Lahey Clinic, Inc.
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-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
A Lahey Clinic IRB approved database and current clinic population of patients having a laparascopic or open prostatectomy
Description
Inclusion Criteria:
- Subjects who have undergone a prostatectomy
Exclusion Criteria:
- none
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The post-surgical questionnaire information collected will be used to determine any benefits to future patients who are to undergo a prostatectomy
Time Frame: Post Surgical
|
Post Surgical
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John A. Libertino, M.D., Lahey Clinic, Inc.
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, 2006
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
June 10, 2008
First Submitted That Met QC Criteria
June 11, 2008
First Posted (Estimate)
June 12, 2008
Study Record Updates
Last Update Posted (Estimate)
December 1, 2008
Last Update Submitted That Met QC Criteria
November 28, 2008
Last Verified
November 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006-014
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.