Open Versus Laparoscopic Radical Cystectomy
OvsL
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 14, 2015
CompletedFirst Posted
Study publicly available on registry
January 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJanuary 26, 2015
January 1, 2015
2 years
January 14, 2015
January 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complication rate
Comparison of the complication rate among the two cohorts of patients under investigation according to the Clavien classification.
24 months
Secondary Outcomes (1)
Health related quality of life
24 months
Study Arms (2)
Laparoscopic radical cystectomy
EXPERIMENTALSurgery: Laparoscopic radical cystectomy with open urinary diversion
Open radical cystectomy
ACTIVE COMPARATORSurgery: Open radical cystectomy with open urinary diversion
Interventions
Laparoscopic surgical procedure in which the bladder is removed because of bladder cancer and a urinary diversion is performed
Open surgical procedure in which the bladder is removed because of bladder cancer and a urinary diversion is performed
Eligibility Criteria
You may qualify if:
- 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
- Recent (within 6 weeks of cystectomy) total body CT imaging study excluding distant metastases as well as upper urinary tract TCC
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vincenzo Pagliarulo
Bari, Italy, 70124, Italy
Related Publications (6)
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.
PMID: 18403100BACKGROUNDHemal 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.
PMID: 19116095BACKGROUNDEdwards 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.
PMID: 12173348BACKGROUNDChamie 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.
PMID: 18410437BACKGROUNDNielsen 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.
PMID: 17113703BACKGROUNDCharlson 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.
PMID: 3558716BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vincenzo VP Pagliarulo, M.D.
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
January 14, 2015
First Posted
January 26, 2015
Study Start
January 1, 2014
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
January 26, 2015
Record last verified: 2015-01