RecruitingNot ApplicableNCT03108196

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

Sponsor

Zhujiang Hospital

Enrollment

96 participants

Start Date

May 2, 2018

Study Type

INTERVENTIONAL

Conditions

Bladder Cancer Urinary Diversion

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two different types of surgically constructed bladders (called neobladders) — one made from part of the colon and one made from part of the small intestine — to see which is safer and works better for patients who need their bladder removed due to cancer. **You may be eligible if...** - You have bladder cancer, including early-stage or muscle-invasive bladder cancer (T2/T3 without widespread spread) - You have recurrent bladder cancer that keeps coming back - A urologist has determined you need a surgical procedure to create a new bladder - You have received prior chemotherapy (given into the bladder, through an artery, or systemically) - You are willing to sign the consent form **You may NOT be eligible if...** - Your kidney function is significantly reduced (creatinine above 2.26 mg/dL) - The cancer has spread into the urethra (confirmed by biopsy) - You do not have bladder cancer but need a new bladder for another reason - You have been diagnosed with another cancer in the past 5 years - You have chronic inflammation of the intestine (such as ulcerative colitis or intestinal tuberculosis) - A urologist has determined the procedure is not suitable for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREsigmoid

The serosal layer with smooth muscle was detached from a 15 cm sigmoid segment submucosal layer and removed continuously. Only the mucosal and submucosal layers were preserved. Approximately 2 cm of the taeniae and serosal layer were preserved to strengthen the urethra-neobladder anastomosis at the central portion of the isolated sigmoid and at the two ends for the ureter-neobladder anastomosis. The ureters were subsequently implanted in antirefluxing fashion in a submucosal tunnel. The ureter-neobladder anastomoses were protected with a 6Fr Single J® stent. The two ends of the sigmoid were closed with the embedded seromuscular layer. The neobladder was anastomosed to the urethra after that.

PROCEDUREileal

The isolated 70 cm terminal ileum segment is arranged in either an M or W shape and is opened along the antimesenteric border except for a 5 cm section where the incision is curved to make a U-shaped ﬂap. The four limbs of the M or W are then sutured to one another with a running absorbable suture. A small full-thickness segment of bowel is excised for the urethral anastomosis. Once the ileal neobladder is situated and the urethral sutures are tied, the ureters are implanted from inside the neobladder through a small incision in the ileum. The remaining portion of the anterior wall is then closed with a running absorbable suture. Ureteroileal anastomosis were performed with a freely refluxing, open end-to-side method at each end of the W.