To examine surgical outcomes and feasibility of blinding patients and care providers to the surgical technique of radical cystectomy (RC).
Patients and MethodsSingle-centre, parallel-group, double-blinded, randomised feasibility study of open RC (ORC) vs robot-assisted RC with intracorporeal urinary diversion (iRARC) in an 'Enhanced Recovery After Surgery' setup. A total of 50 patients aged ≥18 years with bladder cancer planned for RC with an ileal conduit were included. Patients with previous major abdominal/ pelvic surgery, pelvic radiation or anaesthesiological contraindications were excluded. Primary outcomes were proportion of unblinded patients and success of blinding using Bang's Blinding Index. Secondary outcomes included length of stay (LOS), complication rates, blood loss, pain, and opioid consumption.
ResultsA total of 26% of the patients were unblinded before discharge. We demonstrated that patients and doctors remained blinded for the allocated treatment, but nurses did not. Blood loss was greater in the ORC group as was operative time in the iRARC group. We found no difference in complication rate, LOS, or use of analgesics.
ConclusionsThe present study demonstrates that blinding of surgical technique in RC is possible. The results of secondary outcomes are consistent with the findings of previous unblinded randomised controlled trials. Our study highlights that it is possible to perform a blinded phase III study to explore the optimal surgical technique in RC.
Botulinum toxin (BT) is a potent presynaptic neuromuscular blocking agent which induces selective, reversible muscle weakness for months when injected intramuscularly. During recent years BT has revolutionized the treatment of previously intractable symptoms of detrusor overactivity. Based on a systematic search of the PubMed database, a review of the current literature on the use of onabotulinum toxin A (Botox®) in the treatment of neurogenic detrusor overactivity is presented.Onabotulinum toxin A proved to be highly effective in the majority of studies, even though a wide range of injection techniques and dosages were described. The onset of the effect usually appeared before 2 weeks, and reached a peak within 2-6 weeks, with the clinical effect being maintained for approximately 6-8 months, or even longer. Depending on the dose, a number of patients developed high residual volume and clean intermittent self/helper catheterization (CIC) may become necessary. Only a few side effects were described, and intravesical onabotulinum toxin A injection seems to be well tolerated. However, details on injection technique, dose interval between injections, etc. are still under debate and only a few randomized, placebo controlled studies have been published.
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