Alvimopan Accelerates Gastrointestinal Recovery After Radical Cystectomy: A Multicenter Randomized Placebo-Controlled Trial

Background

Radical cystectomy (RC) for bladder cancer is frequently associated with delayed gastrointestinal (GI) recovery that prolongs hospital length of stay (LOS).

Objective

To assess the efficacy of alvimopan to accelerate GI recovery after RC.

Design, setting, and participants

We conducted a randomized double-blind placebo-controlled trial in patients undergoing RC and receiving postoperative intravenous patient-controlled opioid analgesics.

Intervention

Oral alvimopan 12 mg (maximum: 15 inpatient doses) versus placebo.

Outcome measurements and statistical analysis

The two-component primary end point was time to upper (first tolerance of solid food) and lower (first bowel movement) GI recovery (GI-2). Time to discharge order written, postoperative LOS, postoperative ileus (POI)-related morbidity, opioid consumption, and adverse events (AEs) were evaluated. An independent adjudication of cardiovascular AEs was performed.

Results and limitations

Patients were randomized to alvimopan (n = 143) or placebo (n = 137); 277 patients were included in the modified intention-to-treat population. The alvimopan cohort experienced quicker GI-2 recovery (5.5 vs 6.8 d; hazard ratio: 1.8; p < 0.0001), shorter mean LOS (7.4 vs 10.1 d; p = 0.0051), and fewer episodes of POI-related morbidity (8.4% vs 29.1%; p < 0.001). The incidence of opioid consumption and AEs or serious AEs (SAEs) was comparable except for POI, which was lower in the alvimopan group (AEs: 7% vs 26%; SAEs: 5% vs 20%, respectively). Cardiovascular AEs occurred in 8.4% (alvimopan) and 15.3% (placebo) of patients (p = 0.09). Generalizability may be limited due to the exclusion of epidural analgesia and the inclusion of mostly high-volume centers utilizing open laparotomy.

Conclusions

Alvimopan is a useful addition to a standardized care pathway in patients undergoing RC by accelerating GI recovery and shortening LOS, with a safety profile similar to placebo.

Patient summary

This study examined the effects of alvimopan on bowel recovery in patients undergoing radical cystectomy for bladder cancer. Patients receiving alvimopan experienced quicker bowel recovery and had a shorter hospital stay compared with those who received placebo, with comparable safety.

Trial registration

ClinicalTrials.gov identifier NCT00708201     

An estimation of inguinal hernia epidemiology adjusted for population age structure in Tanzania

Purpose

Surgical conditions represent a significant source of global disease burden. Little is known about the epidemiology of inguinal hernia in resource-poor settings. We present a method to estimate inguinal hernia disease burden in Tanzania.

Methods

Using data from the United States National Health and Nutrition Examination Survey (NHANES) prospective cohort study and Tanzanian demographic figures, we calculated inguinal hernia incidence and prevalence in Tanzanian adults under three surgical rate scenarios. Gender-specific incidence figures from NHANES data were adjusted according to Tanzanian population age structure. Hernia duration was adjusted for Tanzanian life expectancy within each age group.

Results

The prevalence of inguinal hernia in Tanzanian adults is 5.36 % while an estimated 12.09 % of men had hernias. Today, 683,904 adults suffer from symptomatic inguinal hernia in Tanzania. The annual incidence of symptomatic hernias in Tanzanian adults is 163 per 100,000 population. At Tanzania’s current hernia repair rate, a backlog of 995,874 hernias in need of repair will develop over 10 years. 4.4 million disability-adjusted life-years would be averted with repair of prevalent symptomatic hernias in Tanzania.

Conclusions

Our data indicate the extent of inguinal hernia disease burden in Tanzania. By adjusting our figures for the age structure of Tanzania, we have demonstrated that while the incidence of symptomatic cases may be lower than previously thought, prevalence of inguinal hernia in Tanzania remains high. This approach provides an update to our previously described methodology for calculation of inguinal hernia epidemiology in resource-poor settings that may be used in multiple country contexts.     

PTSD and Comorbid Psychotic Disorder: Comparison with Veterans Diagnosed with PTSD or Psychotic Disorder

Symptoms of posttraumatic stress disorder (PTSD), psychosis, general psychopathology, role functioning, violence potential, and cognitive and emotional aspects of psychotic states were compared in three groups of veterans. Groups were defined on the basis of their DSM-IV diagnoses: Psychotic disorder and war-related PTSD, war-related PTSD without psychotic symptoms, and psychotic disorder without PTSD. Veterans with PTSD and a comorbid psychotic disorder showed significantly higher levels of positive symptoms of psychosis, general psychopathology, paranoia, and violent thoughts, feelings, and behaviors than the other two groups. These data show that patients with comorbid PTSD and psychotic disorder show levels of cognitive, emotional, and behavioral disturbance that far exceed the levels of disturbance seen in patients with PTSD without psychosis or in patients with psychotic disorder.     

Transvaginal ultrasound examination of women with and without pelvic venous congestion

AIM: To determine if transvaginal ultrasound, including power Doppler examination, can distinguish between women with and without pelvic congestion.MATERIALS AND METHODS: Thirty-six women with pelvic congestion were prospectively examined using transvaginal ultrasonography and standard uterine and ovarian measurements made. Additionally, planimetric measurements of each ovary were taken using an image analysis program to determine the cross-sectional area of ovarian stroma and follicles, if any. Power Doppler images of adnexal vessels were obtained and planimetric estimates of surface area calculated. A congestion score was assigned to each patient, based on vein number, diameter and morphology on grey-scale scanning. Identical measurements were obtained from 19 asymptomatic women and results compared.RESULTS: There was no significant difference between women with pelvic congestion and controls with respect to power Doppler or grey-scale images of adnexal vessels, or congestion score. However, women with pelvic congestion had significantly larger and multicystic ovaries when compared to controls.CONCLUSIONS: Transvaginal ultrasound measurements of adnexal vasculature, including power Doppler measurements, cannot reliably distinguish women with pelvic congestion from controls. However, ultrasound may remain useful for diagnosis of pelvic congestion, predominantly because it is able to visualize multi-cystic ovaries in these patients.     

Delayed Presentations of False Aneurysms of the Subclavian Artery

Delayed presentation of a false aneurysm following blunt trauma is rare with only five cases discussed in literature. We describe two cases of late false aneurysms of the Subclavian artery following blunt injury.     

Evidence Regarding Relationship Between Breastfeeding and Breast Cancer Remains Unclear

Yang L, Jacobsen KH. A systematic review of the association between breastfeeding and breast cancer. J Womens Health 2008;17:1635–45.     

Contemporary Childbirth Education Models

Since the 1960s, childbirth education advocates have attempted to persuade pregnant women that educational preparation for labor and birth is an essential component of the transition to motherhood. Initially, pregnant women who were seeking unmedicated births as a refuge from the inhumane childbirth treatments of the mid‐20th century embraced this view. However, with the changing childbirth climate, including a growing preference for medicated birth, scheduled inductions, and cesarean sections, attendance has diminished and childbirth education finds itself at a crossroads. Commonly used childbirth education models/organizations and several new emerging models along with the available research literature and recommendations for clinical practice and research are presented.