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Comparison of Safety and Efficacy of Detaenial Sigmoid Neobladder and Ileal Neobladder

RecruitingNAAges 18 Years - 100 YearsAllZhujiang Hospital
NCT03108196 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 add

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📋 Eligibility rules (as published)
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 \-
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What it tests

  • sigmoid
  • ileal
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Where

1 site
Zhujiang Hospital
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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