Comparing two types of neobladder surgeries for bladder cancer
A Multicenter Randomized Controlled Study to Compare the Safety and Efficacy of Detaenial Sigmoid Neobladder and Hautmann Ileal Neobladder in Patients With Bladder Cancer
This study is testing two different types of surgeries to create a new bladder for people with bladder cancer to see which one helps them live better and longer after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Zhujiang Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT03108196 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the safety and efficacy of two surgical techniques for creating a neobladder: the detaenial sigmoid neobladder and the ileal neobladder. Patients with muscle invasive bladder cancer or recurrent bladder cancer will undergo one of the two procedures after radical cystectomy. The study aims to evaluate the outcomes related to patient survival and quality of life following these surgical interventions. Participants will be monitored for complications and overall effectiveness of the surgeries.
Who should consider this trial
Good fit: Ideal candidates include individuals with muscle invasive bladder cancer or recurrent bladder cancer who are eligible for neobladder surgery.
Not a fit: Patients with pre-existing urethral invasion or chronic intestinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical options and quality of life for patients undergoing bladder cancer treatment.
How similar studies have performed: Previous studies have shown varying success with neobladder surgeries, but this specific comparison of techniques is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 \-
Where this trial is running
Guangzhou, Guangdong
- Zhujiang Hospital — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Abai Xu, doctor — Zhujiang Hospital
- Study coordinator: Abai Xu, doctor
- Email: lc96xab@163.com
- Phone: +86 18665626790
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.