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: Not available
| S-EPMC10690378 | biostudies-literature
Project description:ObjectivesTo investigate the safety and efficacy of complete laparoscopic ileal augmentation cystoplasty for the treatment of low bladder capacity and compliance.MethodsThe clinical data of 13 patients with low bladder capacity and compliance were retrospectively analyzed. Therapeutic efficacy was evaluated at follow-up. The Clavien system was used to evaluate the severity of postoperative complications.ResultsAll 13 operations were successfully completed laparoscopically. The operation duration was 140-248 min (average: 189.9 ± 29.6 min), the time to postoperative recovery of bowel function was 1-10 days (average: 2.9 ± 2.3 days). There were 4 cases of grade I complications and 1 case of grade II complications (i.e., paralytic ileus caused by urinary leakage from the anastomosis of the augmented bladder). Cystography showed that the morphology of the bladder was close to normal, and the maximum safe capacity and compliance of the bladder were significantly increased [103.8 ± 16.6 mL and 332.3 ± 20.5 mL, p < 0.01; 7.0 ± 1.3 mL/cm H2O and 32.4 ± 2.1 mL/cm H2O, p < 0.01]. All patients were able to urinate spontaneously after catheter removal.ConclusionsComplete laparoscopic ileal augmentation cystoplasty is a safe and feasible treatment for low bladder capacity and compliance, and has the advantages of less trauma, less bleeding, faster recovery of intestinal function, and fewer postoperative complications. This treatment effectively increases bladder capacity, protects upper urinary tract function, and improves patient quality of life, and thus warrants clinical application.
| S-EPMC9006442 | biostudies-literature
Project description:ObjectiveRadical cystectomy with ileal conduit is the current mainstay of treatment for muscle-invasive bladder cancer and is also a high-risk procedure. Existing studies have limited targeted assessment of the efficacy and safety of this procedure, and the patient population appropriate for this procedure is still poorly defined. We sought to longitudinally analyze differences in the efficacy and safety of radical cystectomy with ileal conduit by age subgroups to assess whether the age factor should be used as an exclusion criterion when selecting this procedure.Materials and methodsWe retrospectively examined the clinicopathological data of patients with MIBC treated with RC with IC at the Cancer Hospital of Harbin Medical University between February 2014 and October 2023. Additionally, we utilized clinical and pathological data from the SEER database (2000-2020) for external validation of our findings. Patients were categorized into elderly (≥70 years at diagnosis) and non-elderly (<70 years) groups. Statistical analyses included t-tests, non-parametric tests for continuous data, chi-square tests for categorical data, and Kaplan-Meier survival analysis.ResultsIn this study, 152 patients were included: 119 were categorized as non-elderly and 33 as elderly. For external validation, data from 416 patients in the SEER database were analyzed, with 172 classified as non-elderly and 244 as elderly. The results indicated that elderly patients were more likely to require ICU transfer postoperatively but exhibited a lower incidence of stoma inflammation. Additionally, both the data from our center and the external validation from the SEER database showed a concordance in cancer-specific survival (CSS) between the elderly and non-elderly groups. The efficacy of RC with IC was comparable in both elderly and non-elderly patients.ConclusionFor longitudinal age subgroups, RC with IC for both elderly and non-elderly MIBC had good efficacy and safety, and good quality of life after surgery. Although there are surgical and perioperative risks in elderly patients, there is no significant difference compared with non-elderly patients. In elderly patients requiring RC for bladder cancer, IC should remain the preferred mode of urinary diversion, and old age should not be used as an absolute exclusion criterion for IC.
| S-EPMC11300965 | 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: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: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:IntroductionExtralevator 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 analysisThis 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 disseminationThis experiment was approved by the Biomedical Ethics Committee of West China Hospital of Sichuan University.Trial registrationNCT04177407.
| S-EPMC7310913 | biostudies-literature