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Laparoscopic Vs. Open Prostatectomy Outcomes

This study has been terminated.
(Insufficient findings for data analysis)
Sponsor:
Information provided by:
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT00695773
First received: June 10, 2008
Last updated: November 28, 2008
Last verified: November 2008
History of Changes
  Purpose

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.


Condition
Prostate Cancer Surgery

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Laparoscopic Vs. Open Prostatectomy Outcomes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lahey Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 158
Study Start Date: February 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
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

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

  • Subjects who have undergone a prostatectomy

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00695773

Locations
United States, Massachusetts
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
Investigators
Principal Investigator: John A. Libertino, M.D. Lahey Clinic, Inc.
  More Information

No publications provided

Responsible Party: John A. Libertino, M.D., Lahey Clinic, Inc.
ClinicalTrials.gov Identifier: NCT00695773     History of Changes
Other Study ID Numbers: 2006-014
Study First Received: June 10, 2008
Last Updated: November 28, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Lahey Clinic:
Prostate Cancer Surgery
Laparoscopic surgery for Prostate Cancer
Prostatectomy
Urologic Surgical Procedures

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013