Disease Control Outcomes from Analysis of Pooled Individual Patient Data from Five Comparative Randomised Clinical Trials of Degarelix Versus Luteinising Hormone-releasing Hormone Agonists

Background

Studies comparing the gonadotropin-releasing hormone antagonist, degarelix, with luteinising hormone-releasing hormone (LHRH) agonists indicate differences in outcomes.

Objective

To assess differences in efficacy and safety outcomes in a pooled analysis of trials comparing degarelix with LHRH agonists.

Design, setting, and participants

Data were pooled from five prospective, phase 3 or 3b randomised trials (n = 1925) of degarelix and leuprolide or goserelin in men requiring androgen deprivation therapy for the treatment of prostate cancer. Patients received either 3 mo (n = 467) or 12 mo (n = 1458) of treatment.

Intervention

Men were randomised to receive degarelix (n = 1266), leuprolide (n = 201), or goserelin (n = 458).

Outcome measurements and statistical analysis

Unadjusted Kaplan-Meier analyses were supported by the Cox proportional hazards model, adjusted for disease-related baseline factors, to estimate hazard ratios (HRs) of efficacy and safety outcomes. The Fisher exact test compared crude incidences of adverse events.

Results and limitations

Prostate-specific antigen (PSA) progression-free survival (PFS) was improved in the degarelix group (HR: 0.71; p = 0.017). For patients with baseline PSA levels >20 ng/ml, the HR for PSA PFS was 0.74 (p = 0.052). Overall survival (OS) was higher in the degarelix group (HR: 0.47; p = 0.023). OS was particularly improved with degarelix in patients with baseline testosterone levels >2 ng/ml (HR: 0.36; p = 0.006). In terms of disease-related adverse events, there were, overall, fewer joint-related signs and symptoms, musculoskeletal events, and urinary tract events in the degarelix group.

Conclusions

These data indicate clinical benefits with degarelix, including a significant improvement in PSA PFS and OS, as well as reduced incidence of joint, musculoskeletal, and urinary tract adverse events, compared with LHRH agonists.     

Obesity Is Associated with Increased Prostate Growth and Attenuated Prostate Volume Reduction by Dutasteride

Background

Although obesity has been associated with larger prostate volumes (PV), few studies have actually investigated whether obesity enhances PV growth, especially among men using 5α-reductase inhibitors.

Objective

To examine whether obesity is associated with enhanced PV growth measured by serial transrectal ultrasound (TRUS) measurements.

Design, setting, and participants

We conducted a secondary analysis of the REduction by DUtasteride of prostate Cancer Events (REDUCE) trial, which was originally aimed at cancer risk reduction among high-risk men with a single negative prestudy biopsy.

Intervention

Per-protocol randomization to placebo or dutasteride and mandatory TRUS-guided biopsies at 2 yr and 4 yr.

Outcome measurements and statistical analysis

Percentage change in PV at 2 yr and 4 yr from baseline. We tested its association with baseline body mass index (BMI) groups of <25, 25–29.9, and ≥30 kg/m² using multivariable linear regression. Secondarily, we tested whether BMI was associated with the likelihood of having no PV reduction among men randomized to dutasteride using multivariable logistic regression.

Results and limitations

Of 8122 participants, we analyzed 71.8% and 54.5% with complete 2-yr and 4-yr PV data, respectively. In multivariable analysis, men on placebo with BMI ≥30 versus <25 kg/m² had enhanced PV growth from baseline (at 2 yr: 17.0% vs 10.7%, p < 0.001; at 4 yr: 29.4% vs 20.1%; p = 0.001). Men on dutasteride with BMI ≥30 versus <25 kg/m² had attenuated PV reduction from baseline (at 2 yr: −14.3% vs −18.5%; p = 0.002; at 4 yr: −13.2% vs −19.3%; p = 0.001) and higher likelihood of having no PV reduction (at 2 yr: odds ratio [OR]: 1.44; 95% confidence interval [CI], 1.08–1.93; p = 0.014; at 4 yr: OR: 1.62; 95% CI, 1.18–2.22; p = 0.003). We found no significant interactions between BMI and dutasteride on PV change at 2 yr and 4 yr (p interaction ≥0.36). No clinical outcomes or effects of weight change were assessed.

Conclusions

Obesity enhanced PV growth and attenuated PV reduction by dutasteride. The null interaction between obesity and dutasteride for PV change implies that the effect of obesity on dutasteride-treated men is likely a combination of dutasteride-driven PV reduction with obesity-driven PV growth rather than decreased dutasteride efficacy.

ClinicalTrials.gov identifier

NCT00056407.     

Perioperative Blood Transfusion and Radical Cystectomy: Does Timing of Transfusion Affect Bladder Cancer Mortality?

Background

While perioperative blood transfusion (BT) has been associated with adverse outcomes in multiple malignancies, the importance of BT timing has not been established.

Objective

The objective of this study was to evaluate whether intraoperative BT is associated with worse cancer outcomes in bladder cancer patients treated with radical cystectomy (RC).

Design, setting, and participants

Outcomes from two independent cohorts of consecutive patients with bladder cancer treated with RC were analyzed.

Outcome measurements and statistical analysis

Recurrence-free survival, cancer-specific survival (CSS), and overall survival were estimated and multivariate analyses were performed to evaluate the association of BT timing with cancer outcomes.

Results and limitations

In the primary cohort of 360 patients, 241 (67%) received perioperative BT, including 162 intraoperatively and 79 postoperatively. Five-year CSS was 44% among patients who received an intraoperative BT versus 64% for patients who received postoperative BT (p = 0.0005). After multivariate analysis, intraoperative BT was associated with an increased risk of cancer mortality (hazard ratio [HR]: 1.93; p = 0.02), while receipt of postoperative BT was not (p = 0.60). In the validation cohort of 1770 patients, 1100 (62%) received perioperative BT with a median postoperative follow-up of 11 yr (interquartile range: 8.0–15.7). Five-year RFS (p < 0.001) and CSS (p < 0.001) were significantly worse among patients who received an intraoperative BT. Intraoperative BT was independently associated with recurrence (HR: 1.45; p = 0.001), cancer-specific mortality (HR: 1.55; p = 0.0001), and all-cause mortality (HR: 1.40; p < 0.0001). Postoperative BT was not associated with risk of disease recurrence or cancer death.

Conclusions

Intraoperative BT is associated with increased risk of bladder cancer recurrence and mortality.

Patient summary

In this study, the effects of blood transfusion on bladder cancer surgery outcomes were evaluated. Intraoperative blood transfusion, but not postoperative transfusion, was associated with higher rates of recurrence and cancer-specific mortality.     

Pretreatment Neutrophil-to-Lymphocyte Ratio Is Associated with Advanced Pathologic Tumor Stage and Increased Cancer-specific Mortality Among Patients with Urothelial Carcinoma of the Bladder Undergoing Radical Cystectomy

Background

Pretreatment neutrophil-to-lymphocyte ratio (NLR) is a marker of systemic inflammation that has been associated with adverse survival in a variety of malignancies. However, the relationship between NLR and oncologic outcomes following radical cystectomy (RC) for urothelial carcinoma of the bladder (UCB) has not been well studied.

Objective

To evaluate the association of preoperative NLR with clinicopathologic outcomes following RC.

Design, setting, and participants

We identified 899 patients who underwent RC without neoadjuvant therapy at our institution between 1994 and 2005 and who had a pretreatment NLR.

Outcome measurements and statistical analysis

Preoperative NLR (within 90 d prior to RC) was recorded. Recurrence-free, cancer-specific, and overall survival were estimated using the Kaplan-Meier method and compared using the log-rank test. Multivariate Cox proportional hazard and logistic regression models were used to analyze the association of NLR with clinicopathologic outcomes.

Results and limitations

Median postoperative follow-up was 10.9 yr (interquartile range: 8.3–13.9 yr). Higher preoperative NLR was associated with significantly increased risks of pathologic, extravesical tumor extension (odds ratio [OR]: 1.07; p = 0.03) and lymph node involvement (OR: 1.09; p = 0.02). Univariately, 10-yr cancer-specific survival was significantly worse among patients with a preoperative NLR (≥2.7 [51%] vs <2.7 [64%]; p < 0.001). Moreover, on multivariate analysis, increased preoperative NLR was independently associated with greater risks of disease recurrence (hazard ratio [HR]: 1.04; p = 0.02), death from bladder cancer (HR: 1.04; p = 0.01), and all-cause mortality (HR: 1.03; p = 0.01).

Conclusions

Elevated preoperative NLR among patients undergoing RC is associated with significantly increased risk for locally advanced disease as well as subsequent disease recurrence, and cancer-specific and all-cause mortality. These data suggest that serum NLR may be a useful prognostic marker for preoperative patient risk stratification, including consideration for neoadjuvant therapy and clinical trial enrollment.     

Adverse Events of Intravesical Botulinum Toxin A Injections for Idiopathic Detrusor Overactivity: Risk Factors and Influence on Treatment Outcome

Background

Intravesical injection of botulinum toxin type A (BoNTA) provides effective treatment for detrusor overactivity and overactive bladder (OAB). However, the high rates of treatment-related adverse events (AEs) prevent its more widespread use.

Objective

To investigate the risk factors of increasing AEs after BoNTA injection for idiopathic detrusor overactivity (IDO).

Design, setting, and participants

This study included a total of 217 patients receiving their first intravesical BoNTA injection for refractory IDO in a tertiary university hospital from 2004 to 2009.

Measurements

AE incidence was analyzed according to gender, age, comorbidities, prostate condition in men, OAB subtype, BoNTA dose, injection site, and baseline urodynamic parameters. Successful outcome was determined based on patient perception of improvement of bladder condition at 3 mo.

Results and limitations

Successful outcomes were reported by 144 (66.3%) patients. By multivariable analysis, male gender (p = 0.013) and baseline postvoid residual (PVR) ≥100 ml (p = 0.003) were independent predictors of acute urinary retention (AUR). Baseline PVR ≥100 ml (p = 0.007) and receiving >100 U BoNTA (p = 0.029) were predictors of straining to void. The incidence of large PVR after treatment was associated with comorbidity (p = 0.011). Urinary tract infection occurred more frequently in women (p = 0.003) and in men with retaining prostate (p = 0.008). No AUR developed after bladder base/trigonal injection. Nevertheless, the occurrence of AUR or large PVR did not affect therapeutic outcome. This study is limited by nonconsecutive enrollment of patients.

Conclusions

Male gender, baseline PVR ≥100 ml, comorbidity, and BoNTA dose >100 U are risk factors for increasing incidence of AEs after intravesical BoNTA injection for IDO.     

Application of the Statistical Process Control Method for Prospective Patient Safety Monitoring During the Learning Phase: Robotic Kidney Transplantation with Regional Hypothermia (IDEAL Phase 2a–b)

Background

Traditional evaluation of the learning curve (LC) of an operation has been retrospective. Furthermore, LC analysis does not permit patient safety monitoring.

Objectives

To prospectively monitor patient safety during the learning phase of robotic kidney transplantation (RKT) and determine when it could be considered learned using the techniques of statistical process control (SPC).

Design, setting and participants

From January through May 2013, 41 patients with end-stage renal disease underwent RKT with regional hypothermia at one of two tertiary referral centers adopting RKT. Transplant recipients were classified into three groups based on the robotic training and kidney transplant experience of the surgeons: group 1, robot trained with limited kidney transplant experience (n = 7); group 2, robot trained and kidney transplant experienced (n = 20); and group 3, kidney transplant experienced with limited robot training (n = 14).

Intervention

We employed prospective monitoring using SPC techniques, including cumulative summation (CUSUM) and Shewhart control charts, to perform LC analysis and patient safety monitoring, respectively.

Outcome measurements and statistical analysis

Outcomes assessed included post-transplant graft function and measures of surgical process (anastomotic and ischemic times). CUSUM and Shewhart control charts are time trend analytic techniques that allow comparative assessment of outcomes following a new intervention (RKT) relative to those achieved with established techniques (open kidney transplant; target value) in a prospective fashion.

Results and limitations

CUSUM analysis revealed an initial learning phase for group 3, whereas groups 1 and 2 had no to minimal learning time. The learning phase for group 3 varied depending on the parameter assessed. Shewhart control charts demonstrated no compromise in functional outcomes for groups 1 and 2. Graft function was compromised in one patient in group 3 (p < 0.05) secondary to reasons unrelated to RKT. In multivariable analysis, robot training was significantly associated with improved task-completion times (p < 0.01). Graft function was not adversely affected by either the lack of robotic training (p = 0.22) or kidney transplant experience (p = 0.72).

Conclusions

The LC and patient safety of a new surgical technique can be assessed prospectively using CUSUM and Shewhart control chart analytic techniques. These methods allow determination of the duration of mentorship and identification of adverse events in a timely manner. A new operation can be considered learned when outcomes achieved with the new intervention are at par with outcomes following established techniques.

Patient summary

Statistical process control techniques allowed for robust, objective, and prospective monitoring of robotic kidney transplantation and can similarly be applied to other new interventions during the introduction and adoption phase.     

The health status of people claiming compensation for musculoskeletal injuries following road traffic crashes is not altered by an early intervention programme: A comparative study

Objective

To compare health outcomes among claimants compared to those who were ineligible or choose not to lodge a compensation claim. We also evaluated the effect of an early intervention programme on the health outcomes of the participants.

Design

Prospective comparative study using sequential cohorts.

Subjects

People presenting to hospital emergency departments with mild to moderate musculoskeletal injuries following road traffic crashes.

Intervention

referral to an early intervention programme for assessment by musculoskeletal physician, pain management education, promotion of self-management and encouragement of early activity.

Main outcomes

The 36-Item Short-Form Survey (SF-36); Hospital Anxiety and Depression Scale (HADS) and Functional Rating Index (FRI) scores were assessed at post-crash and at 12 months.

Results

At 12 months, mean scores in six and five of the SF-36 domains were significantly lower among participants who claimed compensation versus those who chose not to claim or were ineligible, respectively. Differences in mean SF-36 scores ranged from 3.0 (‘general health perception’) to 8.0 units (‘role limitations due to physical problems’). Participants who claimed compensation had 6.3- and 4.6-units lower SF-36 physical component score compared to those who were ineligible (p = 0.001) or chose not to claim (p = 0.01), respectively. Participants who claimed compensation reported a worse HADS-depression score of 6.46 versus 4.97 and 4.69 observed in those who were ineligible (p = 0.04) or did not claim (p = 0.01). Claimants had worse FRI scores compared to non-claimants (p = 0.01) and those who were ineligible (p = 0.01). The early intervention did not improve health outcomes, 12 months after injury.

Conclusions

Claiming compensation was associated with a worse health status for people with soft tissue injuries caused by road traffic crashes. The health status in people claiming compensation was not altered by an early intervention programme.     

The primary determinants of radiation use during fixation of proximal femur fractures

Objectives

To establish the primary determinants of operative radiation use during fixation of proximal femur fractures.

Design

Retrospective cohort study.

Setting

Level I trauma centre.

Cohort

205 patients treated surgically for subtrochanteric and intertrochanteric femoral fractures.

Main outcome measures

Fluoroscopy time, dose-area-product (DAP).

Results

Longer fluoroscopy time was correlated with higher body mass index (p = 0.04), subtrochanteric fracture (p < 0.001), attending surgeon (p = 0.001), and implant type (p < 0.001). Increased DAP was associated with higher body mass index (p < 0.001), subtrochanteric fracture (p = 0.002), attending surgeon (p = 0.003), lateral body position (p < 0.001), and implant type (p = 0.05).

Conclusion

The strongest determinants of radiation use during surgical fixation of intertrochanteric and subtrochanteric femur fractures were location of fracture, patient body position, patient body mass index, and the use of cephalomedullary devices. Surgeon style, presumably as it relates to teaching efforts, seems to strongly influence radiation use.     

Randomised Controlled Trial Comparing Laparoscopic and Robot-assisted Radical Prostatectomy

Background

The advantages of robot-assisted radical prostatectomy (RARP) over laparoscopic radical prostatectomy (LRP) have rarely been investigated in randomised controlled trials.

Objective

To compare RARP and LRP in terms of the functional, perioperative, and oncologic outcomes. The main end point of the study was changes in continence 3 mo after surgery.

Design, setting, and participants

From January 2010 to January 2011, 120 patients with organ-confined prostate cancer were enrolled and randomly assigned (using a randomisation plan) to one of two groups based on surgical approach: the RARP group and the LRP group.

Intervention

All RARP and LRP interventions were performed with the same technique by the same single surgeon.

Outcome measurements and statistical analysis

The demographic, perioperative, and pathologic results, such as the complications and prostate-specific antigen (PSA) measurements, were recorded and compared. Continence was evaluated at the time of catheter removal and 48 h later, and continence and potency were evaluated after 1, 3, 6, and 12 mo. The student t test, Mann-Whitney test, χ² test, Pearson χ² test, and multiple regression analysis were used for statistics.

Results and limitations

The two groups (RARP: n = 60; LRP: n = 60) were comparable in terms of demographic data. No differences were recorded in terms of perioperative and pathologic results, complication rate, or PSA measurements. The continence rate was higher in the RARP group at every time point: Continence after 3 mo was 80% in the RARP group and 61.6% in the LRP group (p = 0.044), and after 1 yr, the continence rate was 95.0% and 83.3%, respectively (p = 0.042). Among preoperative potent patients treated with nerve-sparing techniques, the rate of erection recovery was 80.0% and 54.2%, respectively (p = 0.020). The limitations included the small number of patients.

Conclusions

RARP provided better functional results in terms of the recovery of continence and potency. Further studies are needed to confirm our results.     

Oncologic Outcomes Following Three Different Approaches to the Distal Ureter and Bladder Cuff in Nephroureterectomy for Primary Upper Urinary Tract Urothelial Carcinoma

Background

There is a lack of consensus regarding the prognostic significance of different approaches to the bladder cuff at surgery for primary upper urinary tract urothelial carcinoma (UUT-UC).

Objectives

To compare the oncologic outcomes following radical nephroureterectomy using three different methods of managing the bladder cuff.

Design, setting, and participants

From January 1990 to December 2007, 414 patients with primary UUT-UC underwent radical nephroureterectomy at our institution. Of these, 301 were included in our study.

Intervention

Three methods of bladder cuff excision—intravesical incision, extravesical incision, and transurethral incision (TUI)—were performed.

Measurements

Patients’ medical records were reviewed retrospectively. The clinicopathologic data and oncologic outcomes were compared among groups.

Results and limitations

Of the 301 patients, 81 (26.9%) underwent the intravesical method, 129 (42.9%) underwent the extravesical technique, and 91 (30.2%) underwent TUI. There were no differences in clinical and histopathologic data among the three groups. When comparing the intravesical, extravesical, and TUI techniques, bladder recurrence developed in, respectively, 23.5%, 24.0%, and 17.6% cases (p = 0.485); local retroperitoneal recurrence in 7.4%, 7.8%, and 5.5% (p = 0.798); contralateral recurrence in 4.9%, 3.9%, and 2.2% (p = 0.632); and distant metastasis in 7.4%, 10.4%, and 5.5% (p = 0.564). There were no differences in recurrence-free and cancer-specific survival among the three groups (p = 0.680 and 0.502, respectively).

Conclusions

The three techniques had comparable oncologic outcomes. Our data validate the TUI method of bladder cuff control in patients with primary UUT-UC without coexistent bladder tumors.     

A Multicentre Year-long Randomised Controlled Trial of Exercise Training Targeting Physical Functioning in Men with Prostate Cancer Previously Treated with Androgen Suppression and Radiation from TROG 03.04 RADAR

Background

Long-term prostate cancer (PCa) survivors are at increased risk for comorbidities and physical deconditioning.

Objective

To determine the effectiveness of a year-long randomised controlled trial of exercise training in PCa survivors >5 yr postdiagnosis on physical functioning.

Design, setting, and participants

Between 2010 and 2011, 100 long-term PCa survivors from Trans-Tasman Radiation Oncology Group 03.04 Randomised Androgen Deprivation and Radiotherapy previously treated with androgen-deprivation therapy and radiation therapy were randomly assigned to 6 mo of supervised exercise followed by 6 mo of a home-based maintenance programme (n = 50) or printed educational material about physical activity (n = 50) for 12 mo across 13 university-affiliated exercise clinics in Australia and New Zealand.

Intervention

Supervised resistance and aerobic exercise or printed educational material about physical activity.

Outcome measurements and statistical analysis

The primary end point was a 400-m walk as a measure of cardiovascular fitness. Secondary end points were physical function, patient-reported outcomes, muscle strength, body composition, and biomarkers. Analysis of covariance was used to compare outcomes for groups at 6 and 12 mo adjusted for baseline values.

Results and limitations

Participants undergoing supervised exercise showed improvement in cardiorespiratory fitness performance at 6 mo (−19 s [p = 0.029]) and 12 mo (−13 s [p = 0.028]) and better lower-body physical function across the 12-mo period (p < 0.01). Supervised exercise also improved self-reported physical functioning at 6 (p = .006) and 12 mo (p = 0.002), appendicular skeletal muscle at 6 mo (p = 0.019), and objective measures of muscle strength at 6 and 12 mo (p < 0.050). Limitations included the restricted number of participants undertaking body composition assessment, no blinding to group assignment for physical functioning measures, and inclusion of well-functioning individuals.

Conclusions

Supervised exercise training in long-term PCa survivors is more effective than physical activity educational material for increasing cardiorespiratory fitness, physical function, muscle strength, and self-reported physical functioning at 6 mo. Importantly, these benefits were maintained in the long term with a home-based programme with follow-up at 12 mo.

Clinical trial registry

The effect of an exercise intervention on cardiovascular and metabolic risk factors in prostate cancer patients from the RADAR study, ACTRN: ACTRN12609000729224.     

Comparison of Warm Ischemia Versus No Ischemia During Partial Nephrectomy on a Solitary Kidney

Background

The safe duration of warm ischemia during partial nephrectomy (PN) remains controversial.

Objective

To compare the short- and long-term renal effects of warm ischemia versus no ischemia in patients with a solitary kidney.

Design, setting, and participants

Using the Cleveland Clinic and Mayo Clinic databases, we identified 458 patients who underwent open (n = 411) or laparoscopic (n = 47) PN for a renal mass in a solitary kidney between 1990 and 2008. Patients treated with cold ischemia were excluded.

Measurements

Associations of ischemia type (none vs warm) with short- and long-term renal function were evaluated using logistic or Cox regression models.

Results and limitations

No ischemia was used in 96 patients (21%), while 362 patients (79%) had a median of 21 min (range: 4–55) of warm ischemia. Patients treated with warm ischemia had a significantly higher preoperative glomerular filtration rate (GFR; median: 61 ml/min per 1.73 m² vs 54 ml/min per 1.73 m²; p < 0.001) and larger tumors (median: 3.4 cm vs 2.5 cm; p < 0.001) compared with patients treated with no ischemia. Warm ischemia patients were significantly more likely to develop acute renal failure (odds ratio [OR]: 2.1; p = 0.044) and a GFR <15 ml/min per 1.73 m² in the postoperative period (OR: 4.2; p = 0.007) compared with patients who did not have hilar clamping. Among the 297 patients with a preoperative GFR ≥30 ml/min per 1.73 m², patients with warm ischemia were significantly more likely to develop new-onset stage IV chronic kidney disease (hazard ratio: 2.3; p = 0.028) during a mean follow-up of 3.3 yr. Similar results were obtained adjusting for preoperative GFR, tumor size, and type of PN in a multivariable analysis. Limitations include surgeon selection bias when determining type of ischemia.

Conclusions

Warm ischemia during PN is associated with adverse renal consequences. Although selection bias is present, PN without ischemia should be used when technically feasible in patients with a solitary kidney.     

Early tracheostomy improves outcomes in severely injured children and adolescents

Background

Early tracheostomy has been advocated for adult trauma patients to improve outcomes and resource utilization. We hypothesized that timing of tracheostomy for severely injured children would similarly impact outcomes.

Methods

Injured children undergoing tracheostomy over a 10-year period (2002–2012) were reviewed. Early tracheostomy was defined as post-injury day ≤ 7. Data were compared using Student's t test, Pearson chi-squared test and Fisher exact test. Statistical significance was set at p < 0.05 with 95% confidence intervals.

Results

During the 10-year study period, 91 patients underwent tracheostomy following injury. Twenty-nine (32%) patients were < 12 years old; of these, 38% received early tracheostomy. Sixty-two (68%) patients were age 13 to 18; of these, 52% underwent early tracheostomy. Patients undergoing early tracheostomy had fewer ventilator days (p = 0.003), ICU days (p = 0.003), hospital days (p = 0.046), and tracheal complications (p = 0.03) compared to late tracheostomy. There was no difference in pneumonia (p = 0.48) between early and late tracheostomy.

Conclusion

Children undergoing early tracheostomy had improved outcomes compared to those who underwent late tracheostomy. Early tracheostomy should be considered for the severely injured child.

Summary

Early tracheostomy is advocated for adult trauma patients to improve patient comfort and resource utilization. In a review of 91 pediatric trauma patients undergoing tracheostomy, those undergoing tracheostomy on post-injury day ≤ 7 had fewer ventilator days, ICU days, hospital days, and tracheal complications compared to those undergoing tracheostomy after post-injury day 7.     

“Is the length of time in acute burn surgery associated with poorer outcomes?”

Background

Acute wound closure surgery improves outcomes, after burn particularly mortality, but also imposes physiological stress on the patient. The duration of surgery is associated with adverse outcomes in other populations. This study aimed to examine if extended acute burn surgery duration was associated with poorer in-hospital outcomes.

Methods

This retrospective cohort study included adult burn patients who required a single wound closure surgery at Royal Perth Hospital between 2004 and 2011. Multivariable regression analyses were used to assess the influence of patient and injury factors on surgery duration and length of stay (LOS).

Results

Surgery duration independently increased LOS (incidence rate ratio [IRR] = 1.004, p < 0.001). This translates to a predicted 13% increase in LOS for a 30 min increase in surgery ‘knife to skin’ time. Total body surface area (TBSA) was identified as a significant predictor of surgery duration (IRR = 1.047, p < 0.001), estimating that a 10% TBSA increase results in a 59% increase in surgery duration.

Conclusion

The results show that surgery duration is associated with LOS after adjusting for size of burn and other factors. The study justifies the need to explore strategies to reduce acute burn surgery duration.     

Technique and Outcomes of Robot-assisted Retroperitoneoscopic Partial Nephrectomy: A Multicenter Study

Background

Robot-assisted retroperitoneoscopic partial nephrectomy (RARPN) may be used for posterior renal masses or with prior abdominal surgery; however, there is relatively less familiarity with RARPN.

Objective

To demonstrate RARPN technique and outcomes.

Design, setting, and participants

A retrospective multicenter study of 227 consecutive RARPNs was performed at the Swedish Medical Center, the University of Michigan, and the University of California, Los Angeles, from 2006 to 2013.

Surgical procedure

RARPN.

Outcome measurements and statistical analysis

We assessed positive margins and cancer recurrence. Stepwise regression was used to examine factors associated with complications, estimated blood loss (EBL), warm ischemia time (WIT), operative time (OT), and length of stay (LOS).

Results and limitations

The median age was 60 yr (interquartile range [IQR]: 52–66), and the median body mass index (BMI) was 28.2 kg/m² (IQR: 25.6–32.6). Median maximum tumor diameter was 2.3 cm (IQR: 1.7–3.1). Median OT and WIT were 165 min (IQR: 134–200) and 19 min (IQR: 16–24), respectively; median EBL was 75 ml (IQR: 50–150), and median LOS was 2 d (IQR: 1–3). Twenty-eight subjects (12.3%) experienced complications, three (1.3%) had urine leaks, and three (1.3%) had pseudoaneurysms that required reintervention. There was one conversion to radical nephrectomy and three transfusions. Overall, 143 clear cell carcinomas (62.6%) composed most of the histology with eight positive margins (3.5%) and two recurrences (0.9%) with a median follow-up of 2.7 yr. In adjusted analyses, intersurgeon variation was associated with complications (odds ratio [OR]: 3.66; 95% confidence interval, 1.31–10.27; p = 0.014) and WIT (parameter estimate [PE; plus or minus standard error]: 4.84 ± 2.14; p = 0.025). Higher surgeon volume was associated with shorter WIT (PE: −0.06 ± 0.02; p = 0.002). Higher BMI was associated with longer OT (PE: 2.09 ± 0.56; p < 0.001). Longer OT was associated with longer LOS (PE: 0.01 ± 0.01; p = 0.002). Finally, there was a trend for intersurgeon variation in OT (PE: 18.5 ± 10.3; p = 0.075).

Conclusions

RARPN has acceptable morbidity and oncologic outcomes, despite intersurgeon variation in WIT and complications. Greater experience is associated with shorter WIT.

Patient summary

Robot-assisted retroperitoneoscopic partial nephrectomy has acceptable morbidity and oncologic outcomes, and there is intersurgeon variation in warm ischemia time and complications.     

Robotic Partial Nephrectomy with Superselective Versus Main Artery Clamping: A Retrospective Comparison

Background

Concerns have been raised regarding partial nephrectomy (PN) techniques that do not occlude the main renal artery.

Objective

Compare the perioperative outcomes of superselective versus main renal artery control during robotic PN.

Design, setting, and participants

A retrospective analysis of 121 consecutive patients undergoing robotic PN using superselective control (group 1, n = 58) or main artery clamping (group 2, n = 63).

Intervention

Group 1 underwent tumor-specific devascularization, maintaining ongoing arterial perfusion to the renal remnant at all times. Group 2 underwent main renal artery clamping, creating global renal ischemia.

Outcome measurements and statistical analysis

Perioperative and functional data were evaluated. The Pearson chi-square or Fisher exact and Wilcoxon rank sum tests were used.

Results and limitations

All robotic procedures were successful, all surgical margins were negative, and no kidneys were lost. Compared with group 2 tumors, group 1 tumors were larger (3.4 vs 2.6 cm, p = 0.004), more commonly hilar (24% vs 6%, p = 0.009), and more complex (PADUA 10 vs 8, p = 0.009). Group 1 patients had longer median operative time (p < 0.001) and transfusion rates (24% vs 6%, p < 0.01) but similar estimated blood loss (200 vs 150 ml), perioperative complications (15% vs 13%), and hospital stay. Group 1 patients had less decrease in estimated glomerular filtration rate at discharge (0% vs 11%, p = 0.01) and at last follow-up (11% vs 17%, p = 0.03). On computed tomography volumetrics, group 1 patients trended toward greater parenchymal preservation (95% vs 90%, p = 0.07) despite larger tumor size and volume (19 vs 8 ml, p = 0.002). Main limitations are the retrospective study design, small cohort, and short follow-up.

Conclusions

Robotic PN with superselective vascular control enables tumor excision without any global renal ischemia. Blood loss, complications, and positive margin rates were low and similar to main artery clamping. In this initial developmental phase, limitations included more perioperative transfusions and longer operative time. The advantage of superselective clamping for better renal function preservation requires validation by prospective randomized studies.

Patient summary

Preserving global blood flow to the kidney during robotic partial nephrectomy (PN) does not lead to a higher complication rate and may lead to better postoperative renal function compared with clamped PN techniques.     

Temporal Trends,Practice Patterns,and Treatment Outcomes for Infected Upper Urinary Tract Stones in the United States

Background

The incidence of infected urolithiasis is unknown, and evidence describing the optimal management strategy for obstruction is equivocal.

Objective

To examine the trends of infected urolithiasis in the United States, the practice patterns of competing treatment modalities, and to compare adverse outcomes.

Design, setting, and participants

A weighted estimate of 396 385 adult patients hospitalized with infected urolithiasis was extracted from the Nationwide Inpatient Sample, 1999–2009.

Outcome measurements and statistical analysis

Time trend analysis examined the incidence of infected urolithiasis and associated sepsis, as well as rates of retrograde ureteral catheterization and percutaneous nephrostomy (PCN) for urgent/emergent decompression. Propensity-score matching compared the rates of adverse outcomes between approaches.

Results and limitations

Between 1999 and 2009, the incidence of infected urolithiasis in women increased from 15.5 (95% confidence interval [CI], 15.3–15.6) to 27.6 (27.4–27.8)/100 000); men increased from 7.8 (7.7–7.9) to 12.1 (12.0–12.3)/100 000. Rates of associated sepsis increased from 6.9% to 8.5% (p = 0.013), and severe sepsis increased from 1.7% to 3.2% (p < 0.001); mortality rates remained stable at 0.25–0.20% (p = 0.150). Among those undergoing immediate decompression, 113 459 (28.6%), PCN utilization decreased from 16.1% to 11.2% (p = 0.001), with significant regional variability. In matched analysis, PCN showed higher rates of sepsis (odds ratio [OR]: 1.63; 95% CI, 1.52–1.74), severe sepsis (OR: 2.28; 95% CI, 2.06–2.52), prolonged length of stay (OR: 3.18; 95% CI, 3.01–3.34), elevated hospital charges (OR: 2.71; 95%CI, 2.57–2.85), and mortality (OR: 3.14; 95%CI, 13–4.63). However, observational data preclude the assessment of timing between outcome and intervention, and disease severity.

Conclusions

Between 1999 and 2009, women were twice as likely to have infected urolithiasis. Rates of associated sepsis and severe sepsis increased, but mortality rates remained stable. Analysis of competing treatment strategies for immediate decompression demonstrates decreasing utilization of PCN, which showed higher rates of adverse outcomes. These findings should be viewed as preliminary and hypothesis generating, demonstrating the pressing need for further study.     

Effect of fragmentary displacement and morphology in the treatment of comminuted femoral shaft fractures with an intramedullary nail

Objective

Our study aimed to determine whether the displacement and morphology of a fragment in femur fracture with Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association/32-B/32-C (AO/OTA/32-B/32-C) classification affect the outcomes following closed reduction and internal fixation with an interlocking nail.

Design

This was a retrospective study.

Setting

The study was conducted at a Level III trauma centre.

Patients

A total of 50 consecutive patients presenting femoral shaft fracture with AO/OTA-type 32-B/32-C were included in the present study.

Interventions

Patients were divided into two groups according to the displacement of the fragments. In the large displacement group, patients were further subgrouped according to whether a reversed morphology of the fragment was present.

Outcomes measurement

The radiographic union score of femur (RUSF), the mean union time and the re-operation rate were assessed.

Results

The union rate of small- and large-gap groups at 12 months postoperatively was 75.9% and 21.1%, respectively (p = 0.000). The mean union time of those union cases in these two groups was 7.8 and 13.0 months, respectively (p = 0.000). The union rate of the non-reversed and reversed groups at 12 months postoperatively was 30% and 11.1%, respectively (p = 0.179). The mean RUSF at 12 months in the non-reversed and reversed groups was 8.8 and 8.3, respectively (p = 0.590). However, we found that patients presenting a reversed fragment had an increased risk of more than one re-operation (p = 0.030).

Conclusions

A fragmentary displacement of >1 cm in AO/OTA-type 32-B/32-C femoral shaft fracture after nailing affected bone healing. Among the large-gap group patients, an unreduced reverse fragment presented a negative prognostic factor for re-operation.

Level of evidence

Prognostic level III.