Clinical trial · Interventional
Open Versus Laparoscopic Radical Cystectomy
Open Versus Laparoscopic Radical Cystectomy for Invasive Bladder Cancer in the Elderly Patient. A Multicenter Randomized Clinical Trial.
NCT02345499CI-TRIAL-00016690OvsLunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic radical cystectomy with open urinary diversion | Procedure | — | UNRESOLVED |
| Open radical cystectomy with open urinary diversion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laparoscopic radical cystectomy
- description
- Surgery: Laparoscopic radical cystectomy with open urinary diversion
- interventionNames
- Procedure: Laparoscopic radical cystectomy with open urinary diversion
- type
- ACTIVE_COMPARATOR
- label
- Open radical cystectomy
- description
- Surgery: Open radical cystectomy with open urinary diversion
- interventionNames
- Procedure: Open radical cystectomy with open urinary diversion
Primary outcomes (1)
- measure
- Complication rate
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with a histologically proven diagnosis of transitional cell carcinoma of the bladder 2. Patients with an indication to ureterocutaneostomy or ileal conduit 3. ECOG Performance Status ≤ 2 4. 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: 1. 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) 2. Patients who have previously received any pelvic irradiation 3. Patients with a synchronous upper urinary tract malignancy requiring a nephroureterectomy concomitant to cystectomy 4. Patients candidates for a palliative cystectomy (i.e. recurrent haematuria which cannot be treated by endoscopy) 5. Patients with a histologically proven diagnosis of bladder adenocarcinoma, squamous cell carcinoma, and small cell carcinoma
References
Publications (6)
- BACKGROUNDHaber 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 18403100
- BACKGROUNDHemal 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 19116095
- BACKGROUNDEdwards 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 12173348
- BACKGROUNDChamie 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 18410437
- BACKGROUNDNielsen 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 17113703
- BACKGROUNDCharlson 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 3558716