Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
ID03108196

A Multicenter Randomized Controlled Study to Compare the Safety and Efficacy of Detaenial Sigmoid Neobladder and Hautmann Ileal Neobladder in Patients With Bladder Cancer

Led by Zhujiang Hospital · Updated on 2024-12-04

96

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

Z

Zhujiang Hospital

Lead Sponsor

S

Sun Yat-Sen University Cancer Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Bladder cancer is a common malignant tumor affecting the urinary system, and the standard treatment for muscle invasive bladder cancer involves radical resection plus urinary diversion. This trial evaluates two surgical methods for creating a new bladder (neobladder) after removal of the bladder: the traditional Hautmann ileal neobladder and a newer detaenial sigmoid neobladder. The study aims to compare the safety and effectiveness of these two procedures, as no prior multicenter randomized trials have done so worldwide. The Hautmann ileal neobladder uses a 70 cm segment of the terminal ileum, reshaped and sutured to form a reservoir, with the ureters and urethra connected to it. The detaenial sigmoid neobladder involves isolating a 15 to 25 cm segment of the sigmoid colon, removing the serosal layer with smooth muscle while preserving the mucosal layers, and reconstructing it into a "U" shape. Both approaches involve complex surgical techniques to connect the urinary tract and create a new bladder. Patients are randomly assigned to receive one of these two types of neobladder after radical cystectomy. Participants are followed for up to five years with regular evaluations including renal ultrasounds, biochemical tests, urine cultures, pelvic CT scans, retro-cystograms, urodynamic studies, and cystoscopic examinations. Complications are recorded and categorized, and continence levels are assessed through patient interviews. The primary outcome measured is the post void residual volume of the neobladder at 36 months. Secondary outcomes include surgical complications, urinary tract infections, renal function changes, cancer recurrence, and overall survival. This detailed follow-up helps assess the long-term safety and function of each neobladder method.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 100 years
  • Diagnosed with bladder carcinoma in situ, including CIS and T1G3 tumor, or muscle invasive bladder cancer (T2/T3N0-1M0)
  • Recurrent bladder cancer
  • Approved by a urologist for new bladder surgery
  • Received intravesical chemotherapy, intra-arterial infusion chemotherapy, or systemic chemotherapy in the past
  • Voluntarily signed informed consent
Not Eligible

You will not qualify if you...

  • Preoperative serum creatinine more than 2.26 mg/dl (200 µmol/L)
  • Cancer invading the urethra confirmed by pathology
  • Non-bladder cancer patients undergoing neobladder surgery
  • History of other malignant tumors within the past five years
  • Chronic inflammation of ileum or sigmoid colon, such as ulcerative colitis or intestinal tuberculosis
  • Conditions deemed unsuitable for new bladder surgery by a urologist

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgical hospital stay and immediate recovery period

Participants undergo either detaenial sigmoid neobladder or Hautmann ileal neobladder reconstruction after radical cystectomy. This includes the surgical creation of a new bladder from intestinal segments and the implantation of ureters.

1 surgical procedure visit and hospital stay

Post-operative Follow-up

Duration - Up to 5 years

Participants are evaluated regularly for complications, renal function, and urinary continence. Follow-up includes imaging, biochemical tests, and urodynamic and cystoscopic examinations.

Visits every 3 months for 1 year, then every 6 months up to 5 years

Trial Site Locations

Total: 1 location

1

Zhujiang Hospital

Guangzhou, Guangdong, China, 510282

Actively Recruiting

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Research Team

A

Abai Xu, doctor

P

Peng Xu, doctor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Orthotopic sigmoid vs. ileal neobladders in Japanese patients: a comparative assessment of complications, functional outcomes, and quality of life.

Hideaki Miyake, Junya Furukawa, Iori Sakai...

https://pubmed.ncbi.nlm.nih.gov/22153716