Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169676
Status:
COMPLETED
Last Update Posted:
2016-06-29
First Post:
2005-09-09
Brief Title:
Registry and Database Lap Prostatectomy
Sponsor:
Indiana Kidney Stone Institute
Organization:
Indiana Kidney Stone Institute
Study Overview
Official Title:
Laparoscopic Radical Prostatectomy A Registry and Database
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Recently many centers have begun offering laparoscopic radical prostatectomy LRP as a minimally invasive therapy for localized prostate cancer1-6 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
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
Detailed Description:
Prostate cancer is the second leading cause of cancer death in men today An estimated 220900 new cases will be diagnosed in 2003 according to the American Cancer Society7 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 period8
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 morbidity9-13 Refinement of the retropubic approach by Walsh has greatly improved outcomes making it the most common surgical approach for radical prostatectomy14 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 technique16 In 1998 Guillonneau et al introduced the Mountsouris technique in which a transperitoneal approach was used to perform the LRP17 18 Other groups have used this approach and even adapted this technique to perform extraperitoneal approaches to LRP1 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 andor 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 11-462 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
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 morbidity9-13 Refinement of the retropubic approach by Walsh has greatly improved outcomes making it the most common surgical approach for radical prostatectomy14 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 technique16 In 1998 Guillonneau et al introduced the Mountsouris technique in which a transperitoneal approach was used to perform the LRP17 18 Other groups have used this approach and even adapted this technique to perform extraperitoneal approaches to LRP1 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 andor 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 11-462 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None