Registry and Database Lap Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00169676
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : June 29, 2016
Information provided by:
Indiana Kidney Stone Institute

Brief Summary:

Recently, many centers have begun offering laparoscopic radical prostatectomy (LRP) as a minimally invasive therapy for localized prostate cancer.1-6 LRP may offer the advantages of improved neurovascular bundle sparing, a more precise urethrovesical anastomosis, shorter hospitalization, and decreased convalescence.

Our group at Methodist Urology, LLC has extensive experience in laparoscopy and in treating prostate cancer and are planning to offer LRP. We intend to maintain a registry and database to document the outcomes with LRP.

Condition or disease Intervention/treatment
Prostate Cancer Other: observation

Detailed Description:

Prostate cancer is the second leading cause of cancer death in men today. An estimated 220,900 new cases will be diagnosed in 2003 according to the American Cancer Society.7 Prostate cancer will account for one-third of the new cancer diagnoses in men in 2003. Prostate specific antigen (PSA), a sensitive screening method for prostate cancer, has helped diagnose prostate cancer at earlier stages. Stamey et al. found that the diagnosis of prostate cancer in patients with T1c disease (no abnormalities on digital rectal examination but elevated PSA) increased from10% in 1988 to 73% in 1996 and the increase in organ confined cancers increased from 40% to 75% over the same time period.8

Current surgical options for organ confined prostate cancer include open radical retropubic prostatectomy, open radical perineal prostatectomy, radioactive seed implantation, and radiation therapy. Open radical retropubic prostatectomy was pioneered in 1947 by Millin but what was slow to gain widespread acceptance secondary to associated morbidity.9-13 Refinement of the retropubic approach by Walsh has greatly improved outcomes, making it the most common surgical approach for radical prostatectomy.14, 15

As with other procedures, interest in the laparoscopic approach for radical prostatectomy developed in hopes of minimizing patient morbidity. In 1992, Schuessler et al performed the first LRP but the technical difficulties of the procedure at that time prohibited the widespread application of this technique.16 In 1998, Guillonneau et al introduced the Mountsouris technique in which a transperitoneal approach was used to perform the LRP.17, 18 Other groups have used this approach and even adapted this technique to perform extraperitoneal approaches to LRP.1, 2, 4, 5, 19, 20 Many centers are currently offering LRP as primary therapy for organ confined prostate cancer.

All curative surgical therapies for prostate cancer, whether performed in an open or laparoscopic manner, can result in impotence and/or incontinence. Incontinence can be treated with simple measures, such as muscle strengthening exercises, or if more bothersome, can be treated with surgical therapy. Impotence can be treated with medications or, if needed, surgery.

The relative risk of having positive surgical margins in patients undergoing open radical retropubic prostatectomy compared to laparoscopic radical prostatectomy is not known. Preliminary publications regarding laparoscopic radical prostatectomy report rates of positive surgical margins (13-25%) that are similar to open radical prostatectomy (11-46%).2, 5, 6, 19, 21-28 However, long-term follow-up is not available for patients undergoing laparoscopic radical prostatectomy, so the impact of positive margins on long-term survival is not known.

Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Laparoscopic Radical Prostatectomy: A Registry and Database
Study Start Date : June 2003
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Group/Cohort Intervention/treatment
Registry and Database
Other: observation
registry and database for surgery outcomes

Primary Outcome Measures :
  1. To create a registry and database for the treatment of localized prostate cancer with LRP. To record long term outcomes for patients undergoing Laparoscopic Radical Prostatectomy. [ Time Frame: One year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of Methodist Urology that are scheduled to undergo a laser procedure for prostate removal

Inclusion criteria:

  • Patient of Methodist Urology in Indianapolis, IN
  • Ability to give informed consent
  • Biopsy proven diagnosis of prostate cancer without local extension or metastatic disease (Clinical T2 or less in the TNM classification)

Exclusion criteria:

  • Major abdominal surgery precluding a safe laparoscopic approach
  • Bleeding diathesis or anticoagulation
  • Medical disease (such as cardiovascular or pulmonary diseases) precluding general anesthesia/laparoscopy
  • Transplanted kidney in the pelvis
  • Radiation therapy to pelvis
  • Morbid obesity

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 identifier (NCT number): NCT00169676

United States, Indiana
Methodist Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana Kidney Stone Institute
Principal Investigator: Larry Munch, MD Methodist Urology, LLC

Additional Information:
Responsible Party: James Lingeman, MD, Methodist Urology Identifier: NCT00169676     History of Changes
Other Study ID Numbers: 03-040
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: September 2008

Keywords provided by Indiana Kidney Stone Institute:
Prostate Cancer

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