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.

Risk of recurrence and long-term mortality following radical cystectomy for bladder cancer.

PURPOSE: To investigate the risk of recurrence and long-term mortality after radical cystectomy (RC) for bladder cancer (BC) at a high-volume tertiary referral center in Denmark over 19 years. MATERIALS AND METHODS: Patients undergoing RC between the 1st of January 2000 to 31st of December 2018 were included. Patient data were manually retrieved from electronic patient files. Follow-up ended 18th of May 2020. Cumulative incidences were used to assess risk of recurrence and mortality using competing risk modelling. Cause-specific Cox regression models were used for multivariable analysis. RESULTS: A total of 1267 patients underwent RC of which 1042 were eligible for analysis. Overall mortality was 40% and 56% after 5 and 10 years, respectively. The cumulative incidence of recurrence and BC specific mortality was high within the first 2 years. Only 3.2% of the patients with recurrence were alive at the end of follow-up. The cumulative incidence of BC mortality after 5 years was 6.7% (95% CI 3.6-9.9) and 10% (95% CI 6.8-14) for patients with ≤ pT1bN0 and pT2N0, respectively. For patients with lymph node positive disease the cumulative incidence of BC mortality after 5 years was 65% (95% CI 58-71). CONCLUSIONS: We found a significant risk of recurrence and disease-specific mortality following RC for BC, especially within the first 2 years following surgery. Our data seem comparable to other large cohorts. The chance of long-term survival following recurrence is low and there is a continuous need to improve adjuvant or salvage strategies following RC.

Short-term morbidity and mortality following radical cystectomy: a systematic review.

OBJECTIVE: To study short-term (<90 days) morbidity and mortality following radical cystectomy (RC) for bladder cancer and identify modifiable risk factors associated with these. DESIGN: Systematic review. METHODS: The systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. PubMed and EMBASE were searched for relevant papers on 11 June 2019 and rerun on 27 May 2020. Studies reporting complications, reoperations, length of stay and mortality within 90 days were included. Studies were reviewed according to criteria from the Oxford Centre for Evidence-Based Medicine and the quality of evidence was assessed using the Newcastle-Ottawa Scale. RESULTS: The search retrieved 1957 articles. Sixty-six articles were included. The quality of evidence was poor to good. Most studies were retrospective, and no randomised clinical trials were identified. Of included studies a median of 6 Martin criteria for reporting complications after surgery were fulfilled. The Clavien-Dindo classification for grading complications was most frequently used. The weighted overall complication rate after RC was 34.9% (range 28.8-68.8) for in-house complications, 39.0% (range 27.3-80.0) for 30-day complications and 58.5% (range 36.1-80.5) for 90-day complications. The most common types of complications reported were gastrointestinal (29.0%) and infectious (26.4%). The weighted mortality rate was 2.4% (range 0.9-4.7) for in-house mortality, 2.1% (0.0-3.7) for 30-day mortality and 4.7% (range 0.0-7.0) for 90-day mortality. Age and comorbidity were identified as the best predictors for complications following RC. CONCLUSION: Short-term morbidity and mortality are high following RC. Reporting of complications is heterogeneous and the quality of evidence is generally low. There is a continuous need for randomised studies to address any intervention that can reduce morbidity and mortality following RC. PROSPERO REGISTRATION NUMBER: 104937.

Surgical Management of Muscle Invasive Bladder Cancer: A Review of Current Recommendations.

OBJECTIVE: To provide a narrative overview of contemporary surgical management of muscle-invasive bladder cancer with focus on radical cystectomy and urinary tract reconstruction. DATA SOURCES: International guidelines and a search for articles in PubMed, Medline, and Cochrane Database for single and collaborative studies on surgical management of muscle-invasive bladder cancer. CONCLUSION: Patients diagnosed with muscle invasive bladder cancer often have complex treatment and care needs. For those who undergo radical cystectomy as the curative treatment, there is a considerable risk of general complications after major surgery and short- and long-term complications specific to reconstruction of the urinary tract after radical cystectomy. Contemporary care focuses on perioperative optimization to lower rates of major complications, enhanced recovery protocols, and focus on rehabilitation and cancer survivorship. IMPLICATIONS FOR NURSING PRACTICE: Nurses are integral members of the multidisciplinary team around patients undergoing surgery for muscle-invasive bladder cancer, and are in a position to coordinate pathways for these patients who often have complex care needs because of preexisting comorbidity and limited personal resources that impede recovery after major surgery and cancer survivorship.

DaPeCa-4: outcome in penile cancer patients with N3 disease due to extra nodal extension treated with surgery and chemo-irradiation.

Objective: The role of pelvic lymph node dissection (PLND) is still debated in patients with N3 stage penile cancer. In Denmark this subgroup of patients is in general managed with an inguinal lymphadenectomy (ILND) and adjuvant chemoradiation and PLND is not offered as a standard. The objective of this study was to report treatment outcomes of this regimen and compare this with existing literature.Materials and methods: We retrospectively reviewed records of patients with pT1-T4, N3, M0 penile cancer diagnosed between 1st January 2010 and 31th December 2014 in Denmark and treated with curative intend.Results: 21 patients were identified with a median follow up of 74 months (CI 54-94). Management of the penile lesion was local resection in 5 (23.8%), partial penectomy in 10 (47.6%), and total penectomy in 6 (28.6%) of patients. Regarding the most extensive lymph node (LN) surgery: 4 patients (23,8%) went directly to oncological treatment from sentinel node biopsy with no further LN dissection, 6 patients (28.6%) were treated with unilateral ILND, 10 patients (47.6%) with bilateral ILND and a single patient (4.8%) was treated with ILND and PLND. In the adjuvant setting patients were treated with external beam therapy of involved regions and cisplatin-based chemotherapy. Median overall survival was 84 months (CI 0-176). The 5-year probability of surviving penile cancer was 57.1% (CI 36.0-78.3).Conclusion: Treatment with surgery and chemo-irradiation in this national cohort does not show inferior survival outcomes compared to historical cohorts.

Renal trauma: a 6-year retrospective review from a level 1 trauma center in Denmark.

Background: Management of renal trauma injuries is shifting towards more conservative approaches in hemodynamically stable adult patients, even for high grade and/or penetrating trauma. The objective of this study was to analyze the patterns of injury, management and complications in renal trauma patients at a Danish university hospital with a level 1 trauma center.Method: Patients diagnosed with renal trauma at Rigshospitalet, Copenhagen, Denmark, between January 2010 and December 2015 were identified retrospectively by the ICD-10 code. Data were collected from electronic patient records. Imaging was classified by radiologists.Results: Out of 107 patients identified, blunt injuries comprised 93%. Median age was 28. The distribution of injury grade according to AAST was 20% grade I, 4% grade II, 33% grade III, 33% grade IV and 10% grade V. All patients with grade I-III were managed conservatively. Two patients were treated with angioembolization (1 with grade IV and 1 with grade V). Five patients with grade IV were treated with an internal ureteral stent and one patient with grade IV blunt trauma had an emergency nephrectomy performed. Overall complication rate was 7%. No patient died due to their renal injury. Renal function was normal in all patients at discharge, assessed by eGFR measurement. Of the 50% of patients who were followed up with a renography, none developed obstruction due to the renal trauma.Conclusion: The vast majority of renal injuries were due to blunt trauma. Hemodynamically stable patients, even with penetrating and/or high-grade blunt trauma, were managed non-operatively and there was a low rate of complications.

Left sided flank pain due to Bochdalek hernia with intrathoracic kidney.

A 40 year old woman had undergone surgery as a newborn due to a left sided congenital Bochdalek hernia with the ventricle, spleen, left kidney and adrenal gland located intrathoracically. After three pregnancies, she developed left sided flank pain and dyspnea. A CT scan showed a diaphragmatic hernia with a malrotated intrathoracic placed left kidney with minimal hydronephrosis. The spleen was located caudally in the left iliac fossa; there were no other abnormalities. The patient underwent a thoracotomy with a small resection of the diaphragm in order to replace the kidney in the abdominal cavity and closure of the diaphragmatic defect with a Gore-Tex patch.

[Correct diagnostic of traumatic renal trauma is important for the treatment].

Renal trauma is injury to the kidney because of either blunt or penetrating trauma. The condition must be diagnosed quickly and correctly in order to preserve kidney function. This article describes classification, diagnostics, treatment and follow-up. It is important to do a CT-urography to classify the injury properly. The majority of the patients with renal injury can be managed conservatively. Surgical exploration is primarily for the control of haemorrhage. Complications may require additional imaging or inter-ventions. Follow-up is focused on renal function and blood pressure.

Long-term non-invasive ventilation reduces readmissions in COPD patients with two or more episodes of acute hypercapnic respiratory failure.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) patients who have had an episode of acute hypercapnic respiratory failure (AHRF) have a large 1-year risk of death or readmission. Acute non-invasive ventilation (NIV) has been shown to be an effective treatment of AHRF; and long-term NIV (LTNIV) has been shown to be an effective treatment of chronic respiratory failure in stable hypercapnic COPD. We investigated the effects of LTNIV in a group of patients with severe, unstable COPD: frequent admissions and multiple previous episodes of AHRF treated with NIV. METHODS: We conducted a retrospective analysis of 20 COPD patients treated with LTNIV after two or more episodes of AHRF during 1 year. RESULTS: The mean number of AHRF episodes decreased from 2.44 in the year prior to LTNIV initiation to 0.44 in the year following (p<0.0001). The median number of admissions decreased from 5.19 to 1.88 (p=0.0092). Four patients (20%) died in 1 year. LTNIV tended to reduce arterial CO2. No changes were found in lung function. CONCLUSIONS: LTNIV seems effective in reducing recurrent AHRF and readmissions in a highly select group of patients with severe, unstable COPD and frequent AHRF.