Detaenial Sigmoid Neobladder Compared With Hautmann Ileal Neobladder For Bladder Cancer:A Randomized Controlled Study

BackgroundBladder cancer(BC)is one of the most common malignant tumors in the genitourinary system.The incidence rate and mortality of bladder cancer are increasing with age.For Muscle-Invasive Bladder Cancer(MIBC),radical cystectomy with bilateral lymphadenectomy and urinary diversion are the first choice.Early urinary diversion was mainly based on Bricker conduit.With the improvement of living standards,Bricker conduit could not meet the requirements of patients’quality of life.Orthotopic Neobladder could offer a better quality of life by anastomosing the reservoir with the original urethra,so that the patients can urinate through the original urethra.Hautmann ileal neobladder is commonly used.And the ileum needed to be detubularized to achieve low-pressure and large-volume storage capacity of the urine reservoir,by spilt,foled,re-stitched and a series of treatment.Such complicated procedures make it difficult to handle.And at the same time,Vitamin B12 deficiency,metabolic acidosis,urinary retention and even the occurrence of neobladder spontaneous rupture are the obvious disadvantages.Orthotopic Detaenial Sigmoid Neobladder is a new surgical method that detached the serosal layer with smooth muscle from the bowel without split it.And it also achieves low-pressure and large-volume storage capacity.Also,the procedure is simplified,with less complications and better follow-up.And it is gradually widely used.Now,there are few prospective clinical study on on the detaenial sigmoid neobladder and ileal neobladder.Therefore,a multicenter,prospective randomized controlled clinical study is urgently needed.ObjectiveOur study is going to perform a prospective 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.Design,setting,and participants:This is a prospective randomized controlled clinical trial.And the control group is Hautmann ileal neobladder while the experimental group is the detaenial sigmoid neobladder.The participants will be allocated equally into either group by the the central randomization system of Southern Medical University.Each patient was evaluated at 3-month intervals for 1 year,at 6-month intervals for 2 to 5 years.And the primary outcome is Postvoid residual volume of neobladder with urinary diversion in the 36th month.The perioperative data of two groups will be collected and analyzed during the study.ResultA total of 19 patients were enrolled(included 9 in the experimental group and 10 in the control group).There was no significant difference between the two groups in Postvoid residual volume(P>0.05).Compared with Hautmann ileal neobladder,the time of neobladder construction and hospitalization in detaenial sigmoid neobladder were shorter,with significant difference(P<0.05).The short-term complications of the two groups were similar and there was no significant difference in IIEF-5 score and QOL score between the two groups(P>0.05).According to the long term follow-up,there was no significant difference in Qmax and urinary incontinence between the two groups(P>0.05).ConclusionDetaenial sigmoid neobladder is a safe and feasible surgery for bladder cancer,and the short-term effect is similar to that of Hautmann ileal neobladder.Detaenial sigmoid neobladder can offer a similar urinary control to that of Hautmann ileal neobladder in long-term follow-up.