THE ILEAL NEOBLADDER - AN IDEAL BLADDER SUBSTITUTE?
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ABSTRACT:
SUBMITTER: Sood R
PROVIDER: S-EPMC5530306 | biostudies-other | 1996 Apr
REPOSITORIES: biostudies-other
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Project description:Neoadjuvant cisplatin-based combination chemotherapy for muscle-invasive bladder cancer (MIBC) has been shown to confer a survival advantage in two randomized clinical trials and a meta-analysis. Despite level 1 evidence supporting its benefit, utilization remains dismal with nearly one-half of patients ineligible for cisplatin-based therapy because of renal dysfunction, impaired performance status, and/or coexisting medical problems. This situation highlights the need for the development of novel therapies for the management of MIBC, a disease with a lethal phenotype. The neoadjuvant paradigm in bladder cancer offers many advantages for accelerated drug development. First, there is a greater likelihood of successful therapy at an earlier disease state that may be characterized by less genomic instability compared with the metastatic setting, with an early readout of activity with results determined in months rather than years. Second, pre- and post-treatment tumor tissue collection in patients with MIBC is performed as the standard of care without the need for research-directed biopsies, allowing for the ability to perform important correlative studies and to monitor tumor response to therapy in "real time." Third, pathological complete response (pT0) predicts for improved outcome in patients with MIBC. Fourth, there is a strong biological rationale with rapidly accumulating evidence for actionable targets in bladder cancer. This review focuses on the neoadjuvant paradigm for accelerated drug development using bladder cancer as the ideal model.
| S-EPMC3755931 | biostudies-literature
Project description:BackgroundRadical cystectomy (RC) with urinary diversion is the recommended treatment for selected cases of non-metastatic high-risk non-muscle-invasive and muscle-invasive bladder cancer. It remains unknown whether robot-assisted laparoscopic cystectomy (RARC) offers any advantage in terms of safety compared to open cystectomy (ORC) in an Enhanced Recovery After Surgery (ERAS) setup. Blinded randomised controlled trials (RCTs) between RARC versus ORC have never been conducted in cystectomy patients. We will investigate the feasibility of conducting a double-blinded RCT comparing ORC with RARC with intra-corporal ileal conduit (iRARC) in an ERAS setup.MethodsThis is a single-centre, double-blinded, randomised (1:1) clinical feasibility study for patients with non-metastatic high-risk non-muscle-invasive or muscle-invasive bladder cancer scheduled for cystectomy. All participants are recruited from Rigshospitalet, Denmark. The planned sample size is 50 participants to investigate whether blinding of the surgical technique is feasible. Participants and postoperative caring physicians and nurses are blinded using a pre-study designed abdominal dressing and blinding of the patient's electronic health record. Study endpoints are assessed 90 days postoperatively. The primary aim is to study the frequency and pattern of unplanned unblinding after surgery and the number of participants who cannot guess the surgical technique at the day of discharge. Eleven secondary endpoints are assessed: length of stay, days alive and out of hospital, in-hospital complication rate, 30-day complication rate, 90-day complication rate, readmission rate, quality of life, blood loss, pain, rate of moderate/severe post-anaesthesia care unit (PACU) complications, and delirium. Participants are managed in an ERAS setup in both arms of the trial.DiscussionWe report on the design and objectives of a novel experimental feasibility study investigating whether blinding of the surgical technique in cystectomy patients is possible. This information is essential for the design of future blinded trials comparing ORC to RARC. There is a continued need to compare RARC and ORC in terms of both efficacy, safety, and oncological outcomes. Estimated end of study is March 2021.Trial registrationClinicalTrials.gov ID: NCT03977831. Registered on the 6th of June 2019.
| S-EPMC9838067 | biostudies-literature
Project description:Interstitial cystitis/bladder pain syndrome (IC/BPS) is a complex syndrome that has long been treated with bladder directed therapies, which often fail to address the multiple underlying etiologies that can contribute to this disease process. This disease often involves symptoms that extend beyond the bladder and involve the pelvic floor making it crucial for clinicians to approach the patient using a multidisciplinary team. This article will discuss the underlying etiologies for IC/BPS and describe the multidisciplinary approach which we have found to be extremely successful in managing this patient population.
| S-EPMC4708537 | biostudies-other
Project description:BACKGROUND:There is no quality evidence of the benefit of defunctioning ileostomy (DI) in ileal pouch-anal anastomoses (IPAAs) performed for inflammatory bowel disease (IBD), but most surgical teams currently resort to DI. In the case of a staged procedure with subtotal colectomy first, completion proctectomy with IPAA is performed for healthy patients, namely, after nutritional support, inflammation reduction and immunosuppressive agent weaning. Therefore, the aim of this trial is to assess the need for systematic DI after completion proctectomy and IPAA for IBD. METHODS/DESIGN:This is a multicenter randomized open trial comparing completion proctectomy and IPAA without (experimental) or with (control) DI in patients presenting with ulcerative colitis or indeterminate colitis. Crohn's disease patients will not be included. The design is a superiority trial. The main objective is to compare the 6-month global postoperative morbidity, encompassing both surgical and medical complications, between the two groups. The morbidity of DI closure will be included, as appropriate. The sample size calculation is based on the hypothesis that the overall 6-month morbidity rate is 30% in the case of no stoma creation (i.e., experimental group) vs. 55% otherwise (control group). With the alpha risk and power are fixed to 0.05 and 0.80, respectively, and considering a dropout rate of 10%, the objective is set to 194 patients. The secondary objectives are to compare both strategies in terms of morbi-mortality at 6?months and functional results as well as quality of life at 12?months, namely, the 6-month major morbidity and unplanned reoperation rates, 6-month anastomotic leakage rate, 6-month mortality, length of hospital stay, 6-month unplanned readmission rate, quality of life assessed 3 and 12?months from continuity restoration (i.e., either IPAA or stoma closure), functional results assessed 3 and 12?months from continuity restoration, 12-month pouch results, 12-month cost-utility analysis, and 12-month global morbidity. DISCUSSION:The IDEAL trial is a nationwide multicenter study that will help choose the optimal strategy between DI and no ileostomy in completion proctectomy with IPAA for IBD. TRIAL REGISTRATION:ClinicalTrial.gov: NCT03872271, date of registration March 13th, 2019.
| S-EPMC6909507 | biostudies-literature
Project description:AbstractTo review the most used intracorporeal orthotopic ileal neobladder (ICONB) after radical cystectomy for bladder cancer and create a unified compendium of the different alternatives, including new consistent images.MethodsWe performed a non-systematic review of the literature with the keywords "bladder cancer", "urinary diversion", "radical cystectomy", and "neobladder".ResultsForty studies were included in the analysis. The most frequent type of ICONB was the modified Studer "U" neobladder (70%) followed by the Hautmann "W" modified neobladder (7.5%), the "Y" neobladder (5%), and the Padua neobladder (5%). The operative time to perform a urinary diversion ranged from 124 to 553 min. The total estimated blood loss ranged from 200 to 900 mL. The rate of positive surgical margins ranged from 0% to 8.1%. Early minor and major complication rates ranged from 0% to 100% and from 0% to 33%, respectively. Late minor and major complication rates ranged from 0% to 70% and from 0% to 25%, respectively.ConclusionThe most frequent types of ICONB are Studer "U" neobladder, Hautmann "W" neobladder, "Y" neobladder, and the Padua neobladder. Randomized studies comparing the performance of the different types of ICONB, the performance in an intra or extracorporeal manner, or the performance of an ICONB versus ICIC are lacking in the literature. To this day, there are not sufficient quality data to determine the supremacy of one technique. This manuscript represents a compendium of the most used ICONB with detailed descriptions of the technical aspects, operative and perioperative outcomes, and new consistent images of each technique.
| S-EPMC7859454 | biostudies-literature
Project description:INTRODUCTION:Extralevator abdominoperineal excision (ELAPE) may cause various surgical complications including disruption of perineal wound, perineal hernia and adhesive small-bowel obstruction. Pelvic peritoneum reconstruction (PPR) could prevent those complications, but it may not always be achievable, especially in patients with severe pelvic fibrosis after neoadjuvant radiotherapy. Our previous study has reported the application of the PPR using the bladder peritoneum flap in laparoscopic ELAPE. The aim of the study is to evaluate the short-term clinical, technical and safety outcomes of PPR using the bladder peritoneum flap in laparoscopic ELAPE. METHODS AND ANALYSIS:This is a multi-center prospective single-arm cohort study and fulfill the IDEAL 2A stage principle. Rectal cancer patients undergoing laparoscopic ELAPE, suffering rigid pelvis or huge perineal peritoneum defect, and having difficulty in primary perineal wound closure will be considered eligible. Main exclusion criteria are being complicated with urgent complications, ASA grade >3 and accompanied with mental illness. After informed consent, 30 patients are planned to be included in the study. Standard laparoscopic ELAPE with pelvic peritoneal floor reconstruction using bladder peritoneum flap are to be performed. The surgical safety is to be evaluated after one-year follow-up. Primary endpoints are the occurrence of intraoperative and postoperative complications of PPR using the bladder peritoneum flap. Second endpoints are overall complication rate within 30 days after surgery, extent of small intestine falling down to pelvic cavity, and other follow-up consequences within 1 year after surgery. ETHICS AND DISSEMINATION:This experiment was approved by the Biomedical Ethics Committee of West China Hospital of Sichuan University. TRIAL REGISTRATION:NCT04177407.
| S-EPMC7310913 | biostudies-literature
Project description:ObjectiveIleal conduit urinary diversion (ICUD) is the most common procedure after radical cystectomy. Although complications have been reported, few patients with ICUD and bladder preservation controls have been available for long-term follow-up. This study compared the long-term effect of structural changes after cystectomy with ICUD to that in bladder preservation controls.DesignA retrospective nationwide cohort study.SettingData retrieved from the Taiwan National Health Insurance Research Database.ParticipantsThe National Health Insurance database was explored for patients diagnosed with bladder cancer between 1997 and 2006. Only cancer-free patients without chemotherapy and other types of urinary diversion who lived for >5 years were included in the analysis.Outcome measuresPatient characteristics, comorbidity and postoperative urinary tract disease were statistically analysed and compared. Cox proportional hazards model was used to evaluate the incidence rates of outcomes after adjustment for covariates. Propensity scores analysis was used to balance the clinical parameters between groups. The primary outcomes were postoperative new-onset urinary tract disease such as urinary tract infection (UTI), UTI with septicaemia and chronic kidney disease (CKD), or calculus of kidney and ureter.ResultsThere were 11?185 patients included in our cohort, among which 703 (6.3%) and 10?482 (93.7%) patients received ICUD and bladder preservation procedure, respectively. Compared with patients who only underwent a bladder preservation procedure, those who had undergone ICUD after cystectomy were independently associated with postoperative de novo urinary tract disease. Propensity score analysis (1:4) was also performed. ICUD contributed to significantly higher new-onset UTI, UTI with sepsis and CKD (HR=1.30, 3.16, 1.35, respectively) compared with bladder preservation procedure after adjustment for age, gender and comorbidities.ConclusionICUD after radical cystectomy was associated with a higher incidence of UTI, UTI with septicaemia and CKD during long-term follow-up than the incidences following a bladder preservation procedure.
| S-EPMC6292418 | biostudies-literature
Project description:BackgroundBladder cancer (BCa) is the most common urinary malignancy. The standard surgical treatment for patients with muscle-invasive BCa is cystectomy plus urinary diversion. Ileal conduit (IC) or orthotopic neobladder (ON), which have different indications, are the most commonly performed urinary diversions.Methods and materialsWe sampled 5480 BCa patients from the Surveillance, Epidemiology, and End Results (SEER) database from 2004 to 2015. Kaplan-Meier method with the log-rank test was used to assess cancer-specific survival (CSS) and overall survival (OS). Univariate and multivariate Cox's proportional hazard model was conducted to evaluate the hazard ratio of cancer-specific mortality and all-cause mortality before and after propensity score matching (PSM).ResultsWe identified 5480 patients who received radical cystectomy (RC) plus IC (n = 5071) or ON (n = 409) with a median follow-up period of 33 months (interquartile range, 13-78 months). Patients in the ON group tended to be male and younger, with a higher percentage of married individuals, early pathological T stage, lymphadenectomy, and non-radiotherapy (all P < .05). After 1:1 PSM, 409 matched pairs were selected. Univariate and multivariate analysis showed that the ON group had better CSS and OS probabilities than the IC group in the overall cohort [hazard ratio (HR): 0.692, 95% confidence intervals (CI): 0.576-0.831, P < .001; HR: 0.677, 95% CI: 0.579-0.793, P < .001 respectively]. However, subgroup analysis revealed that only patients with pathological T2 stage benefited from ON diversion after PSM in the context of CSS (P = .016) and OS (P <.001).ConclusionsYoung, married, and male patients with early pathological T stage, especially T2 stage, were more suitable to receive RC plus ON surgery, which could improve their probability of survival.
| S-EPMC7571812 | biostudies-literature
Project description:Previous genome-wide expression studies have highlighted distinct gene expression patterns in inflammatory bowel disease (IBD) compared to control samples, but the interpretation of these studies has been limited by sample heterogeneity with respect to disease phenotype, disease activity, and anatomic sites. To further improve molecular classification of inflammatory bowel disease phenotypes we focused on a single anatomic site, the disease unaffected proximal ileal margin of resected ileum, and three phenotypes that were unlikely to overlap: ileal Crohn's disease (ileal CD), ulcerative colitis (UC), and control patients without IBD. Whole human genome (Agilent) expression profiling was conducted on two independent sets of disease-unaffected ileal samples collected from the proximal margin of resected ileum. Set 1 (47 ileal CD, 27 UC, and 25 Control non-IBD patients) was used as the training set and Set 2 was subsequently collected as an independent test set (10 ileal CD, 10 UC, and 10 control non-IBD patients). We compared the 17 gene signatures selected by four different feature-selection methods to distinguish ileal CD phenotype with non-CD phenotype. The four methods yielded different but overlapping solutions that were highly discriminating. All four of these methods selected FOLH1 as a common feature. This gene is an established biomarker for prostate cancer, but has not previously been associated with Crohn's disease. Immunohistochemical staining confirmed increased expression of FOLH1 in the ileal epithelium. These results provide evidence for convergent molecular abnormalities in the macroscopically disease unaffected proximal margin of resected ileum from ileal CD subjects.
| S-EPMC3351422 | biostudies-literature
Project description:BackgroundNOD2 single nucleotide polymorphisms have been associated with increased risk of ileal Crohn's disease (CD). This exploratory study was conducted to compare ileal mucosal gene expression in CD patients with and without NOD2 risk alleles.MethodsIleal samples were prospectively collected from 18 nonsmoking CD patients not treated with anti-TNF-α biologics and 9 nonsmoking control patients without inflammatory bowel disease undergoing initial resection and genotyped for the 3 major NOD2 risk alleles (Arg702Trp, Gly908Arg, Leu1007fs). Microarray analysis was performed in samples from 4 NOD2(R) (at least 1 risk allele) CD patients, 4 NOD2(NR) (no risk alleles) CD patients, and 4 NOD2(NR) controls. Candidate genes selected by significance analysis of microarrays (SAM) were confirmed by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) assays of all the samples.ResultsSAM detected upregulation of 18 genes in affected ileum in NOD2(R) compared to NOD2(NR) CD patients, including genes related to lymphocyte activation. SAM also detected altered ileal gene expression in unaffected NOD2(NR) ileal mucosal CD samples compared to NOD2(NR) control samples. qRT-PCR conducted on all the samples confirmed that increased CD3D expression in affected samples was associated with NOD2(R) status, and that increased MUC1, DUOX2, DMBT1 and decreased C4orf7 expression in unaffected samples was associated with CD, independent of NOD2 status.ConclusionsThe results support the concept that NOD2 risk alleles contribute to impaired regulation of inflammation in the ileum. Furthermore, altered ileal gene expression, independent of NOD2 status, is detected in the unaffected proximal margin of resected ileum from CD patients.
| S-EPMC4002261 | biostudies-literature