St Jean De Sixt, France

Neoadjuvant Sasanlimab With Radiation as an in Situ Vaccine for Cisplatin-ineligible Muscle Invasive Bladder Cancer

Patients with cT2-T4a, N0, M0 urothelial bladder carcinoma (UBC) after transurethral resection of the bladder will receive 2 doses of sasanlimab (PF-06801591) at the dose of 300mg subcutaneously, followed by 3 doses of radiation (8Gy x 3) prior to surgery (radical cystectomy). Cystectomy will be planned to be done within 6 weeks of the last dose of sasanlimab. Pathologic complete response (pT0) is the primary endpoint, in addition to a safety lead-in endpoint consisting of a composite outcome of feasibility and safety. Exploratory biomarker analysis on tissue/blood samples will include genomic and immune-system profiling in tumor and blood before and after sasanlimab/radiation therapy, and after radical cystectomy.

Decision Making for Urinary Diversion in Patients With Bladder Cancer

The Investigator aims to elicit the patient and provider experiences through conducting a 90-minute interview, using an interview guide the research team has developed, using established qualitative research methods for in-depth individual interviews. The team will structure the interviews with broad, open-ended questions to elicit personal thoughts, emotions and experiences regarding decision making for urinary diversion. The team will use the information collected from this interview to make a tool valuable in developing a patient decision aid. For patients who have not undergone surgery yet, the team will ask the patient if it is okay to contact after their surgery to reassess the patients responses to the same questions from the first interview. In Aim 2, the team will complete part one of the Ottawa decision framework by assessing the patients' and urologists' determinates of decisions for urinary diversion and identify support needs. Using established qualitative research methods for in-depth individual interviews, the team will structure the interviews with broad, open-ended questions to elicit personal thoughts, emotions and experiences regarding decision making for urinary diversion. Informed by Aim 2 the team will develop a web-based development of a decision aid. The development process will use both the Ottawa decision support and IPDAS to center the design empathetic to the user. The aim will be consistent with principles where the users take priority in the IPDAS guidelines framework and the needs assessment framework. The team will develop a decision support tailored to patients needs who are undergoing urinary diversion and then evaluate the decision making process. The decision aid will use the preferences from the themes of the individual interviews to give patients a preferred method of urinary diversion. The team will perform this in a pre-post fashion. As mentioned previously, patients will be recruited from the urologists' clinical work. The Indiana and Neobladder patients may have different vantage points in the perioperative period, however at 6-months this should no longer be different. In addition, the team will have patients use the decision aid at 1-month postoperatively to obtain feedback. Getting patient feedback from the group will be critical with such a large number of patients recruited. The research assistant will identify eligible patients prior to their clinic encounter and obtain informed consent. Patients will then complete the decision aid prior to the visit with the surgeon and bring the completed tool into the clinical encounter. After completing the visit, the patient and research assistant will complete the questionnaires assessing acceptability, knowledge, treatment decision and decisional conflict. One month after surgery, our team will also complete the same questionnaires, as well as patient satisfaction and regret at the 6-month follow-up visit. If patients are not available for the visit, our team will attempt to complete telehealth or telephone interviews.

Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion

Th research team proposes to increase the rate of sterilization of urine from patients with urinary diversion and reduce the incidence of UTI up to 30 ± 7 days post radical cystectomy and urinary diversion using 50 ± 25ml of Irrisept ® irrigation solution lavage of the bowel segment during surgery for a contact time of 2 minutes. For patients who obtain an ileal conduits irrigation using 50 ± 25ml of Irrisept ® will be performed daily for 10 days +/- 3 days and for those patients obtaining ileal neobladders irrigation using 50 ± 25ml of Irrisept ® will continue for 21 days +/- 7 days. The irrigation will continue for the given time described above as this is usually when stents and catheters are removed.

Efficacy and Safety of a Continent Cutaneous Urinary Diversion in Spinal Cord Injury Patients

Patient Experiences Following Urinary Diversion as Part of Surgery for Advanced and Recurrent Rectal Cancer

Considerable progress has been made in the management of advanced and recurrent pelvic cancer over the last few decades. However, much emphasis has been placed on surgical and hospital-related outcomes. In recent years, there has been an increased focus on patient quality-of-life following major abdominopelvic surgery. However, there is a lack of updated evidence on how patients manage and perceive their stomas. Managing a stoma is a difficult task for patients and can adversely effect their quality-of-life. This study will investigate specifically the impact of managing a urostomy or ileal conduit. Patients will be contacted via an anonymized, opt-in SMS or email to answer a questionnaire, having previously been provided with a patient information leaflet. This will take approximately 5 minutes to complete and will be carried out just prior to and at 1, 3, 6, 9 and 12 months post-operatively. All of this data will be collated and published as part of a wider investigation in to patient quality-of-life following major abdominal and pelvic surgery. This study will be carried out in 35 countries.