Clinical trial · Interventional
Comparison of Safety and Efficacy of Detaenial Sigmoid Neobladder and Ileal Neobladder
A Multicenter Randomized Controlled Study to Compare the Safety and Efficacy of Detaenial Sigmoid Neobladder and Hautmann Ileal Neobladder in Patients With Bladder Cancer
- 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)
Bladder cancer is a common malignant tumor of the urinary system, radical resection plus urinary diversion is the first choice of treatment for muscle invasive bladder cancer. Urinary diversion of surgical options related to patient' survival and quality of life. In 1988, Hautmann firstly reported an orthotopic urinary diversion method: Hautmann neobladder. As the urine can be controlled from the original urethra, the patient's quality of life has been greatly improved, so the new bladder surgery gradually accepted and welcomed by urologists and patients. However, in order to achieve low-pressure and large-volume storage capacity of the urine reservoir, the 40-70cm long interception of terminal ileum need to be detubularized. Only after split, folded, re-stitched and a series of treatment, the intestinal can be used. Such complicated procedures make so many urologists give it up. In addition, the interception of the long ileum may lead to reduced absorption of vitamin B12 which caused anemia, metabolic acidosis, intestinal dysfunction. Not only that, as time goes by, this kind of neobladder will be unlimited expansion and resulting in a serious increase in residual urine volume, hydronephrosis, or even the occurrence of neobladder spontaneous rupture. In 2000, professor Chunxiao Liu invented "detaenial sigmoid neobladder", this surgical method overset the traditional intestinal detubularization approach, which detached the serosal layer with smooth muscle from the bowel without split it. This kind of neobladder is easier to construct and have less impact on intestinal function. So far, it has been implemented for more than 600 cases in Zhujiang hospital, the age of patients range from 9 months (bladder rhabdomyosarcoma) to 84 years old. So far as now, no multicenter prospective clinical study on orthotopic urinary diversion has been performed worldwide, neither the head-to-head studies on detaenial sigmoid neobladder and ileal neobladder. Our project is going to perform a multicenter randomized controlled trial for these two neobladder methods and look forward to assess the safety and efficacy of these two procedures which provide an objective basis for the patients undergoing orthotopic urinary diversion in the future.
Conditions
Conditions (2)
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 |
| Urinary Diversion | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ileal | Procedure | — | UNRESOLVED |
| sigmoid | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- sigmoid
- description
- Use 15 cm detaenial sigmoid colon to reconstructed a "U" shape neobladder after radical cystectomy.
- interventionNames
- Procedure: sigmoid
- type
- EXPERIMENTAL
- label
- ileal
- description
- Use 70 cm distal ileal segment to reconstructed a "spherical" shape neobladder after radical cystectomy.
- interventionNames
- Procedure: ileal
Primary outcomes (1)
- measure
- Post void residual volume of neobladder
- timeFrame
- the 36th month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. Bladder carcinoma in situ, include CIS and T1G3 tumor, muscle invasive bladder cancer(T2/T3N0-1M0) 2. Recurrent bladder cancer 3. Other conditions that have been approved by a urologist for indications for new bladder surgery 4. Had been received intravesical chemotherapy, intra-arterial infusion chemotherapy or systemic chemotherapy in the past. 5. Voluntarily signed the informed consent - Exclusion Criteria: 1. Preoperative serum creatinine more than 2.26mg/dl(Or 200μmol/L) 2. Cancer invaded urethral (confirmed by the pathology) 3. Non - bladder cancer patients underwent neobladder 4. A history of other malignant tumors within five years 5. Ileum / sigmoid chronic inflammation, like ulcerative colitis or intestinal tuberculosis, and so on. 6. Other conditions that have been approved by a urologist for not suitable for new bladder surgery \-
References
Publications (12)
- BACKGROUNDZerhau P, Husar M. [Mucus production consequences in cystoplasties and continent urinary diversions in children--long term experiences]. Rozhl Chir. 2006 Mar;85(3):148-50. Czech. PMID 16689148
- BACKGROUNDHaupt G, Pannek J, Knopf HJ, Schulze H, Senge T. Rupture of ileal neobladder due to urethral obstruction by mucous plug. J Urol. 1990 Sep;144(3):740-1. doi: 10.1016/s0022-5347(17)39571-x. PMID 2388342
- BACKGROUNDSkinner EC, Fairey AS, Groshen S, Daneshmand S, Cai J, Miranda G, Skinner DG. Randomized Trial of Studer Pouch versus T-Pouch Orthotopic Ileal Neobladder in Patients with Bladder Cancer. J Urol. 2015 Aug;194(2):433-9. doi: 10.1016/j.juro.2015.03.101. Epub 2015 Mar 28. PMID 25823791
- BACKGROUNDBacchetti P, Leung JM. Sample size calculations in clinical research. Anesthesiology. 2002 Oct;97(4):1028-9; author reply 1029-32. doi: 10.1097/00000542-200210000-00050. No abstract available. PMID 12357184
- BACKGROUNDJulious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004 Jun 30;23(12):1921-86. doi: 10.1002/sim.1783. PMID 15195324
- BACKGROUNDMiyake H, Furukawa J, Sakai I, Muramaki M, Yamashita M, Inoue TA, Fujisawa M. Orthotopic sigmoid vs. ileal neobladders in Japanese patients: a comparative assessment of complications, functional outcomes, and quality of life. Urol Oncol. 2013 Oct;31(7):1155-60. doi: 10.1016/j.urolonc.2011.11.015. Epub 2011 Dec 6. PMID 22153716
- BACKGROUNDClavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.