Surgical Complications Following Renal Transplantation in a Large Institutional Cohort.

Background: Successful renal transplantation (RTx) relies on immunosuppression and an optimal surgical course with few surgical complications. Studies reporting the postoperative complications after RTx are heterogeneous and often lack systematic reporting of complications. This study aims to describe and identify postoperative short-term and long-term complications after RTx in a large institutional cohort and identify risk factors for a complicated surgical course. Methods: The study is a retrospective single-center cohort of 571 recipients who underwent living or deceased donor open RTx between 2014 and 2021. Data were collected on background information and perioperative and postoperative data. Complications were defined as short-term (<30 d) or long-term (>30 d) after transplantation and graded according to the Clavien-Dindo classification. Multivariable logistic regression was performed to evaluate risk factors for serious short-term complications and multivariable time-dependent Cox regression to evaluate risk factors for long-term complications. Results: A total of 351 patients received a graft from a deceased donor, and 144 of these grafts were on perfusion machine before transplantation. One or more short-term complications occurred in 345 (60%) patients. Previous RTx was associated with short-term Clavien-Dindo >2 complications in recipients (odds ratio = 2.08; 95% confidence interval [CI], 1.18-3.69; P = 0.01). Being underweight (body mass index <18.5) in combination with increasing age increased the odds of short-term Clavien-Dindo >2 and vascular complications. Increasing blood loss per 100 mL was associated with increased odds of short-term Clavien-Dindo >2 (odds ratio = 1.11; 95% CI, 1.01-1.21; P = 0.032). No associations were found for long-term complications after RTx. The 5-y cumulative incidence of graft loss was 12.6% (95% CI, 8.9-16.3). Conclusions: Short-term complications are common after RTx, and risk factors for severe short-term complications include previous RTx, increasing age, and low body mass index. No risk factors were identified for severe long-term complications. Further studies should explore whether new surgical techniques can reduce surgical complications in RTx.

Kidney transplant in Denmark.

Since the first kidney transplant was conducted in Denmark in 1964, almost 10,000 transplants have been performed. Graft survival has improved over the past two decades despite the increase in age and comorbidities in both donors and recipients, but organ shortage remains a challenge. The focus of this review is to describe the challenges in kidney transplant and highlight the progress achieved in solving these challenges.

Robot-assisted laparoscopic radical cystectomy with intracorporeal ileal conduit diversion versus open radical cystectomy with ileal conduit for bladder cancer in an ERAS setup (BORARC): protocol for a single-centre, double-blinded, randomised feasibility study.

BACKGROUND: Radical 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. METHODS: This 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. DISCUSSION: We 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 REGISTRATION: ClinicalTrials.gov ID: NCT03977831. Registered on the 6th of June 2019.

Quality of life and secondary outcomes for open versus robot-assisted radical cystectomy: a double-blinded, randomised feasibility trial.

PURPOSE: This study aims to examine quality of life (QoL) before and after radical cystectomy (RC) and compare robot-assisted laparoscopy with intracorporeal urinary diversion (iRARC) to open radical cystectomy (ORC). METHODS: This study is a predefined secondary analysis of a single-centre, double-blinded, randomised feasibility trial. Fifty patients were randomly assigned to iRARC with ileal conduit (n = 25) or ORC with ileal conduit (n = 25). Patients were followed 90 days postoperatively. The primary outcome was patient-reported QoL using the EORTC Cancer-30 and muscle-invasive bladder cancer BLM-30 QoL questionnaires before and after RC. Differences between randomisation arms as well as changes over time were evaluated. Secondary outcomes included 30- and 90 day complication rates, 90 day readmission rates, and 90 day days-alive-and-out-of-hospital and their relationship to QoL. RESULTS: All patients underwent the allocated treatment. We found no difference in QoL, complication rates, readmission rates, and days-alive-and-out-of-hospital between randomisation arms. An overall improvement in QoL was found in the following domains: future perspectives, emotional functioning, and social functioning. Sexual functioning worsened postoperatively. There was no association between having experienced a major complication or lengthy hospitalisation and worse postoperative QoL. CONCLUSION: The QoL does not appear to depend on surgical technique. Apart from sexual functioning, patients report stable or improved QoL within the first 90 postoperative days.

Open vs robot-assisted radical cystectomy (BORARC): a double-blinded, randomised feasibility study.

OBJECTIVE: To examine surgical outcomes and feasibility of blinding patients and care providers to the surgical technique of radical cystectomy (RC). PATIENTS AND METHODS: Single-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. RESULTS: A 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. CONCLUSIONS: The 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.

Simulation-based training for flexible cystoscopy - A randomized trial comparing two approaches.

BACKGROUND: Simulation-based training allows trainees to experiment during training and end-of-training tests could increase motivation and retention. The aim of this trial was to determine if a simulation-based training program including directed self-regulated learning and post-testing improved clinical outcomes compared to a traditional simulation-based training program. METHODS: A randomized trial was conducted involving 32 participants without prior experience in endoscopic procedures. The intervention group practiced independently in a simulation centre and got a post-test whereas the control group received traditional instructions and demonstrations before being allowed to practice. Three weeks after the intervention the participants performed cystoscopies on two consecutive patients. Clinical performance was assessed using a global rating scale (GRS) with established evidence of validity. Independent samples t-test, Cronbach's α, Pearson's r, and paired samples t-test were used for statistical analysis. RESULTS: Twenty-five participants performed two cystoscopies on patients. There was no significant difference between the two study groups with respect to mean GRS of performance (p = 0.63, 95 % CI; -2.4-3.9). The internal consistency of the global rating scale was high, Cronbach's α = 0.91. Participants from both study groups demonstrated significant improvement between the first and second clinical procedures (p = 0.004, 95 % CI, 0.8-3.5). Eight (32%) and 15 (60%) participants demonstrated adequate clinical skills in their first and second procedure, respectively. CONCLUSIONS: No significant differences were found on the clinical transfer when comparing the two programs. Neither of our training programs was able to ensure consistent, competent performance on patients and this finding could serve as an important argument for simulation-based mastery learning where all training continues until a pre-defined level of proficiency is met. TRIAL REGISTRATIONS: The trial was submitted before enrolment of participants to the Regional Scientific Ethics Committee of the Capital Region which established that ethical approval was not necessary (H-4-2014-122). The trial was registered at Clinicaltrials.gov (NCT02411747).

Robotic versus laparoscopic urological surgery: incidence of reoperation and complications.

Objective: To report the introduction of minimum invasive surgery in Denmark with focus on the reoperation and complication rates. Materials and methods: Data were prospectively collected at the national UroLap database. The database was established in 2003 in Denmark to register all laparoscopic urological procedures as well as their peri- and post-operative outcomes. In the period from 2009-2014, 10,843 patients were registered with the database, of which 10,546 (97%) had a complete Clavien-Dindo score within the first 30 postoperative days. Results: The mean age of patients was 60.5 years (S.D. = 16.2), and 415 patients (4%) were under the age of 17 years. The male-to-female ratio was 4:1. At the end of 2010, 25% of surgeries used the robotic technique, but the frequency of robotic surgeries increased to 56% in 2014. No complications were reported in 74.6% of the urological procedures. The mortality rate was reported at only 0.27% of all patients. Patients who underwent a urological procedure performed by consultant urologists had a lower rate of complication compared to procedures performed by trainees (p = 0.03) but not staff doctors (p = 0.9). There were no significant differences in complication rates between staff doctors and trainee (p = 0.2). Conclusion: Robotic and laparoscopic urological procedures are associated with low serious complication rates. Postoperative complications were more common among surgeries performed by trainees. The robotic approach is associated with a shorter L.O.S. compared to the laparoscopic approach and linked to lower reoperation rates.

Direct Observation vs. Video-Based Assessment in Flexible Cystoscopy.

OBJECTIVE: Direct observation in assessment of clinical skills is prone to bias, demands the observer to be present at a certain location at a specific time, and is time-consuming. Video-based assessment could remove the risk of bias, increase flexibility, and reduce the time spent on assessment. This study investigated if video-based assessment was a reliable tool for cystoscopy and if direct observers were prone to bias compared with video-raters. DESIGN: This study was a blinded observational trial. Twenty medical students and 9 urologists were recorded during 2 cystoscopies and rated by a direct observer and subsequently by 2 blinded video-raters on a global rating scale (GRS) for cystoscopy. Both intrarater and interrater reliability were explored. Furthermore, direct observer bias was explored by a paired samples t-test. RESULTS: Intrarater reliability calculated by Pearson's r was 0.86. Interrater reliability was 0.74 for single measure and 0.85 for average measures. A hawk-dove effect was seen between the 2 raters. Direct observer bias was detected when comparing direct observer scores to the assessment by an independent video-rater (p < 0.001). CONCLUSION: This study found that video-based assessment was a reliable tool for cystoscopy with 2 video-raters. There was a significant bias when comparing direct observation with blinded video-based assessment.

Nonspecialist Raters Can Provide Reliable Assessments of Procedural Skills.

BACKGROUND: Competency-based learning has become a crucial component in medical education. Despite the advantages of competency-based learning, there are still challenges that need to be addressed. Currently, the common perception is that specialist assessment is needed for evaluating procedural skills which is difficult owing to the limited availability of faculty time. The aim of this study was to explore the validity of assessments of video recorded procedures performed by nonspecialist raters. METHODS: This study was a blinded observational trial. Twenty-three novices (senior medical students) and 9 experienced doctors were video recorded while each performing 2 flexible cystoscopies on patients. The recordings were anonymized and placed in random order and then rated by 2 experienced cystoscopists (specialist raters) and 2 medical students (nonspecialist raters). Flexible cystoscopy was chosen as it is a simple procedural skill that is crucial to master in a resident urology program. RESULTS: The internal consistency of assessments was high, Cronbach's α = 0.93 and 0.95 for nonspecialist and specialist raters, respectively (p < 0.001 for both correlations). The interrater reliability was significant (p < 0.001) with a Pearson's correlation of 0.77 for the nonspecialists and 0.75 for the specialists. The test-retest reliability showed the biggest difference between the 2 groups, 0.59 and 0.38 for the nonspecialist raters and the specialist raters, respectively (p < 0.001). CONCLUSION: Our study suggests that nonspecialist raters can provide reliable and valid assessments of video recorded cystoscopies. This could make mastery learning and competency-based education more feasible.

Onabotulinum toxin a (botox®) in the treatment of neurogenic bladder overactivity.

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.