Open Versus Laparoscopic Radical Cystectomy (OvsL)
Primary Purpose
Bladder Cancer
Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Laparoscopic radical cystectomy with open urinary diversion
Open radical cystectomy with open urinary diversion
Sponsored by
About this trial
This is an interventional supportive care trial for Bladder Cancer focused on measuring Radical cystectomy, Laparoscopy
Eligibility Criteria
Inclusion Criteria:
- Patients with a histologically proven diagnosis of transitional cell carcinoma of the bladder
- Patients with an indication to ureterocutaneostomy or ileal conduit
- ECOG Performance Status ≤ 2
- WBC count ≥4,000/μL; platelet count ≥150,000/μL
4.Recent (within 6 weeks of cystectomy) total body CT imaging study excluding distant metastases as well as upper urinary tract TCC
Exclusion Criteria:
- Patients who have previously undergone lower abdominal and/or pelvic surgery for invasive cancer (i.e. radical prostatectomy, large bowel surgeries with or without ileal/colonic conduit)
- Patients who have previously received any pelvic irradiation
- Patients with a synchronous upper urinary tract malignancy requiring a nephroureterectomy concomitant to cystectomy
- Patients candidates for a palliative cystectomy (i.e. recurrent haematuria which cannot be treated by endoscopy)
- Patients with a histologically proven diagnosis of bladder adenocarcinoma, squamous cell carcinoma, and small cell carcinoma
Sites / Locations
- Vincenzo PagliaruloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Laparoscopic radical cystectomy
Open radical cystectomy
Arm Description
Surgery: Laparoscopic radical cystectomy with open urinary diversion
Surgery: Open radical cystectomy with open urinary diversion
Outcomes
Primary Outcome Measures
Complication rate
Comparison of the complication rate among the two cohorts of patients under investigation according to the Clavien classification.
Secondary Outcome Measures
Health related quality of life
Comparison of health related quality of life among the two cohorts under investigation according to the SF-36 questionnaire
Full Information
NCT ID
NCT02345499
First Posted
January 14, 2015
Last Updated
January 19, 2015
Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
1. Study Identification
Unique Protocol Identification Number
NCT02345499
Brief Title
Open Versus Laparoscopic Radical Cystectomy
Acronym
OvsL
Official Title
Open Versus Laparoscopic Radical Cystectomy for Invasive Bladder Cancer in the Elderly Patient. A Multicenter Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To date, no trials have been designed to compare open Vs laparoscopic radical cystectomy in the elderly patients, both in terms of functional and clinical outcome measures. A more meaningful comparison of the two modalities is that of a randomized controlled trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Radical cystectomy, Laparoscopy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic radical cystectomy
Arm Type
Experimental
Arm Description
Surgery: Laparoscopic radical cystectomy with open urinary diversion
Arm Title
Open radical cystectomy
Arm Type
Active Comparator
Arm Description
Surgery: Open radical cystectomy with open urinary diversion
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic radical cystectomy with open urinary diversion
Intervention Description
Laparoscopic surgical procedure in which the bladder is removed because of bladder cancer and a urinary diversion is performed
Intervention Type
Procedure
Intervention Name(s)
Open radical cystectomy with open urinary diversion
Intervention Description
Open surgical procedure in which the bladder is removed because of bladder cancer and a urinary diversion is performed
Primary Outcome Measure Information:
Title
Complication rate
Description
Comparison of the complication rate among the two cohorts of patients under investigation according to the Clavien classification.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Health related quality of life
Description
Comparison of health related quality of life among the two cohorts under investigation according to the SF-36 questionnaire
Time Frame
24 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with a histologically proven diagnosis of transitional cell carcinoma of the bladder
Patients with an indication to ureterocutaneostomy or ileal conduit
ECOG Performance Status ≤ 2
WBC count ≥4,000/μL; platelet count ≥150,000/μL
4.Recent (within 6 weeks of cystectomy) total body CT imaging study excluding distant metastases as well as upper urinary tract TCC
Exclusion Criteria:
Patients who have previously undergone lower abdominal and/or pelvic surgery for invasive cancer (i.e. radical prostatectomy, large bowel surgeries with or without ileal/colonic conduit)
Patients who have previously received any pelvic irradiation
Patients with a synchronous upper urinary tract malignancy requiring a nephroureterectomy concomitant to cystectomy
Patients candidates for a palliative cystectomy (i.e. recurrent haematuria which cannot be treated by endoscopy)
Patients with a histologically proven diagnosis of bladder adenocarcinoma, squamous cell carcinoma, and small cell carcinoma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincenzo VP Pagliarulo, M.D.
Phone
+39 080 5595228
Email
vpagliarulo@urologia.uniba.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincenzo VP Pagliarulo, M.D.
Organizational Affiliation
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vincenzo Pagliarulo
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincenzo VP Pagliarulo, Urologist
Phone
+ 39 080 559 5228
Email
vpagliarulo@urologia.uniba.it
First Name & Middle Initial & Last Name & Degree
Vincenzo VP Pagliarulo, Urologist
Phone
+39 080 559 5228
Email
vpagliarulo@urologia.uniba.it
12. IPD Sharing Statement
Citations:
PubMed Identifier
18403100
Citation
Haber GP, Crouzet S, Gill IS. Laparoscopic and robotic assisted radical cystectomy for bladder cancer: a critical analysis. Eur Urol. 2008 Jul;54(1):54-62. doi: 10.1016/j.eururo.2008.03.076. Epub 2008 Apr 1.
Results Reference
background
PubMed Identifier
19116095
Citation
Hemal AK. Robotic and laparoscopic radical cystectomy in the management of bladder cancer. Curr Urol Rep. 2009 Jan;10(1):45-54. doi: 10.1007/s11934-009-0009-8.
Results Reference
background
PubMed Identifier
12173348
Citation
Edwards BK, Howe HL, Ries LA, Thun MJ, Rosenberg HM, Yancik R, Wingo PA, Jemal A, Feigal EG. Annual report to the nation on the status of cancer, 1973-1999, featuring implications of age and aging on U.S. cancer burden. Cancer. 2002 May 15;94(10):2766-92. doi: 10.1002/cncr.10593.
Results Reference
background
PubMed Identifier
18410437
Citation
Chamie K, Hu B, Devere White RW, Ellison LM. Cystectomy in the elderly: does the survival benefit in younger patients translate to the octogenarians? BJU Int. 2008 Aug;102(3):284-90. doi: 10.1111/j.1464-410X.2008.07636.x. Epub 2008 Apr 11.
Results Reference
background
PubMed Identifier
17113703
Citation
Nielsen ME, Shariat SF, Karakiewicz PI, Lotan Y, Rogers CG, Amiel GE, Bastian PJ, Vazina A, Gupta A, Lerner SP, Sagalowsky AI, Schoenberg MP, Palapattu GS; Bladder Cancer Research Consortium (BCRC). Advanced age is associated with poorer bladder cancer-specific survival in patients treated with radical cystectomy. Eur Urol. 2007 Mar;51(3):699-706; discussion 706-8. doi: 10.1016/j.eururo.2006.11.004. Epub 2006 Nov 13.
Results Reference
background
PubMed Identifier
3558716
Citation
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
Results Reference
background
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Open Versus Laparoscopic Radical Cystectomy
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