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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorZhujiang Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Bladder carcinoma in situ, include CIS and T1G3 tumor, muscle invasive bladder cancer(T2/T3N0-1M0)

Recurrent bladder cancer

Other conditions that have been approved by a urologist for indications for new bladder surgery

Had been received intravesical chemotherapy, intra-arterial infusion chemotherapy or systemic chemotherapy in the past.

Disqualifiers

Preoperative serum creatinine more than 2.26mg/dl(Or 200μmol/L)

Cancer invaded urethral (confirmed by the pathology)

Non - bladder cancer patients underwent neobladder

A history of other malignant tumors within five years

Trial design

Design model

Parallel

Treatments tested in this trial

  • sigmoid

    Procedure/Surgery

    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.

  • ileal

    Procedure/Surgery

    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.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: sigmoidExperimental treatment 1 intervention
Group B: ilealExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Post void residual volume of neobladder

Residual urine volume after spontaneous urination with urinary diversion in the 36th month

Time frame
the 36th month

Secondary outcomes

1

Time cost

Time consuming of neobladder construction

Time frame
24 hour
2

EBL

Estimated blood loss

Time frame
24 hour
3

Short term complications

Complications which happened during 90 day postoperative

Time frame
90 day postoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhujiang Hospital

Lead sponsor

Sun Yat-Sen University Cancer Center

Collaborator

The Third Affiliated Hospital of Southern Medical University

Collaborator

Fourth Affiliated Hospital of Guangxi Medical University

Collaborator

Ludwig-Maximilians - University of Munich

Collaborator