Conectar
The impact of anaesthesia modality on oncological outcomes in patients with high-risk non-muscle invasive bladder cancer (NMIBC) remains uncertain. Emerging evidence suggests that anaesthetic agents and techniques may influence tumour biology and recurrence through immunomodulatory and neuroendocrine pathways. However, prospective randomised trials comparing spinal and general anaesthesia in this population are lacking.
This single-centre, prospective, parallel-arm randomised controlled trial will enrol 370 patients with clinically suspected high-risk NMIBC undergoing transurethral resection of bladder tumour. Participants will be randomised 1:1 to receive either spinal or general anaesthesia. The primary endpoint is time to recurrence over a 104-week follow-up period. Secondary endpoints include time to progression, Bacillus Calmette–Guérin (BCG) unresponsiveness and a composite oncological event. Additional secondary outcomes include postoperative opioid consumption (morphine equivalents), obturator jerk occurrence, acute urinary retention and tolerance to immediate intravesical chemotherapy. Safety outcomes will include treatment-emergent adverse events, Clavien-Dindo graded surgical complications, haemorrhagic events and anaesthesia-related risks. Exploratory endpoints involve perioperative biomarker analyses. Data will be analysed on an intention-to-treat basis.
Recruitment has not yet started. It is expected to begin in December 2025 and to be completed by June 2029. The planned follow-up period for each participant is 104 weeks. This manuscript is based on protocol V.1.0, dated March 2025. Results will be disseminated through peer-reviewed journals and conference presentations
This project explores the feasibility of setting up a neuropsychiatric de-identified database (DiD) and a Research Register (RR) to collect, analyse, monitor and systematically report clinical data for people with intellectual disabilities (PwIDs) and epilepsy.
A multicentre project designed to collect de-identified data from clinical records at three adult ID specialist services in England and Wales and to develop an RR of PwID and epilepsy. Patients added to the DiD will be identified from patient clinic lists, clinic letters, in-house databases and electronic systems. Patients to be added to the RR will also be identified through attendance for regular review at clinic appointments. The collected data will be entered into the Research Electronic Data Capture (REDCap) database. Personal details of PwID and their consultees will also be collected from participants who consent to be on the RR. Around 600 PwID and epilepsy (200 per site) will be added to the DiD at the three sites, while around 45–60 participants (15–20 per site) are anticipated to be added to the RR. Data analysis will involve using descriptive statistics to summarise feasibility outcomes, such as screening and recruitment rates, as well as the completeness of the collected data. The characteristics of the participants (demographic, ID classification, clinical, epilepsy history and antiseizure medication) will be summarised descriptively. Progression will be assessed using the Red/Amber/Green stop-go criteria to determine if a national register should be created.
Ethical approval (24/NW/0210) has been obtained from the Northwest-Haydock Research Ethics Committee and the University of Plymouth Faculty Research Ethics and Integrity Committee (reference no. 5284). The project is funded by Jazz Pharmaceuticals as an independent investigator-initiated support grant and, as such, has received independent peer review.
FreshRSS 