Lessons From Implementing a Clinical Research Network in Brazil.

In this article, we discuss the strategy designed by a private oncology group to offer patients access to new technologies and treatments via a recently created research program, and we describe how the patient journey was the motivation for developing standard assistance flows and processes to integrate areas of care. The increase in Brazilians' life expectancy has raised the incidence of cancer, and it is now the second leading cause of death. Because it is a multifactorial disease, cancer treatment has several challenges. We elected to approach cancer research using a strategic program to obtain national attention and visibility. Starting in 2007, the initial project included three phases: phase I, diagnosis of units in major metropolitan areas; phase II, project design, with a central-office operation model; and phase III, implementation, with launch and integration of research activities at selected units. The foundation of the program was the construction of departmental and interdepartmental flows, standard operating processes, and guidelines (regulatory, ethical, legal, and financial). Recruitment of qualified professionals was another critical, successful determinant. The benefits of an additional central office include improved research-project distribution. Another advantage of the program is attracting and retaining trained professionals with alternative direct or indirect sources of revenue. We increased our corporate and academic partnerships, adhered to deadlines and noted an improvement in turnaround times, and we increased clinical staff engagement and motivation. Some barriers continue to challenge the program's continued expansion, including Brazilian regulatory authority approval, tax inefficiency, and a growing demand for qualified professionals. Research sites offering high-quality care are a reality in Brazil; they offer multiple lines of treatment in the public and private sectors.

Determinants of COVID-19 Mortality in Patients With Cancer From a Community Oncology Practice in Brazil.

PURPOSE: The COVID-19 pandemic remains a public health emergency of global concern. Determinants of mortality in the general population are now clear, but specific data on patients with cancer remain limited, particularly in Latin America. MATERIALS AND METHODS: A longitudinal multicenter cohort study of patients with cancer and confirmed COVID-19 from Oncoclínicas community oncology practice in Brazil was conducted. The primary end point was all-cause mortality after isolation of the SARS-CoV-2 by Real-Time Polymerase Chain Reaction (RT-PCR) in patients initially diagnosed in an outpatient environment. We performed univariate and multivariable logistic regression analysis and recursive partitioning modeling to define the baseline clinical determinants of death in the overall population. RESULTS: From March 29 to July 4, 2020, 198 patients with COVID-19 were prospectively registered in the database, of which 167 (84%) had solid tumors and 31 (16%) had hematologic malignancies. Most patients were on active systemic therapy or radiotherapy (77%), largely for advanced or metastatic disease (64%). The overall mortality rate was 16.7% (95% CI, 11.9 to 22.7). In univariate models, factors associated with death after COVID-19 diagnosis were age ≥ 60 years, current or former smoking, coexisting comorbidities, respiratory tract cancer, and management in a noncurative setting (P < .05). In multivariable logistic regression and recursive partitioning modeling, only age, smoking history, and noncurative disease setting remained significant determinants of mortality, ranging from 1% in cancer survivors under surveillance or (neo)adjuvant therapy to 60% in elderly smokers with advanced or metastatic disease. CONCLUSION: Mortality after COVID-19 in patients with cancer is influenced by prognostic factors that also affect outcomes of the general population. Fragile patients and smokers are entitled to active preventive measures to reduce the risk of SARS-CoV-2 infection and close monitoring in the case of exposure or COVID-19-related symptoms.

Perineal rectosigmoidectomy for primary and recurrent rectal prolapse: are the results comparable the second time?

BACKGROUND: The surgical approach to recurrent full-thickness rectal prolapse after perineal rectosigmoidectomy is complicated by recurrent prolapse. The majority of patients who undergo perineal rectosigmoidectomy are elderly with comorbidities. Therefore, redo perineal rectosigmoidectomy is usually selected to avoid postoperative complications. OBJECTIVE: This study aimed to evaluate the safety and efficacy of redo perineal rectosigmoidectomy for recurrent full-thickness rectal prolapse. DESIGN: This is a retrospective cohort study. SETTING: This study was conducted at Cleveland Clinic Florida, from January 2000 to March 2009. PATIENTS: One hundred thirty-six patients (129 women), mean age 78 (range, 31-98) years, were included in the study; 113 patients with full-thickness rectal prolapse underwent primary perineal rectosigmoidectomy, and 23 patients with recurrent full-thickness rectal prolapse underwent redo perineal rectosigmoidectomy. INTERVENTIONS: All patients underwent perineal rectosigmoidectomy. MAIN OUTCOME MEASURES: Perioperative outcomes, recurrence curves, and risk of recurrence were compared between the 2 groups. Age, anterior compartment prolapse, concurrent levatorplasty, and length of bowel resection were analyzed to identify factors potentially influencing recurrence. RESULTS: Both groups had comparable demographics, BMI, and ASA scores. Operative time, blood loss, length of bowel resection, hospital stay, and follow-up (mean, 42.5 months) were similar in both groups. There was no significant difference in overall complication rates (redo perineal rectosigmoidectomy 17.4% vs. primary perineal rectosigmoidectomy 16.8%; p = 1.00). The recurrence rate for full-thickness rectal prolapse was significantly higher for redo perineal rectosigmoidectomy than primary perineal rectosigmoidectomy (39% vs. 18%; p = 0.007). None of the factors analyzed was associated with recurrence in either group. LIMITATIONS: This study was limited by its retrospective methodology. In addition, functional outcomes were not evaluated, because many of the patients died during the follow-up period or were unavailable because of advanced age. CONCLUSIONS: Redo perineal rectosigmoidectomy is as safe and feasible as primary perineal rectosigmoidectomy in elderly and fragile patients with recurrent full-thickness rectal prolapse. However, the re-recurrence rate for full-thickness rectal prolapse is substantially higher for redo perineal rectosigmoidectomy than primary perineal rectosigmoidectomy.

Outcome of laparoscopic rectopexy versus perineal rectosigmoidectomy for full-thickness rectal prolapse in elderly patients.

BACKGROUND: The balance between abdominal and perineal approaches for rectal prolapse is always the higher morbidity but better outcome in the former setting. Therefore, perineal approaches have been preferred for the treatment of full-thickness rectal prolapse (FTRP) in elderly patients. However, laparoscopic rectopexy with or without resection also may be used for elderly patients and may confer the same benefits. PURPOSE: The objective of this study was to evaluate safety and efficacy of laparoscopic rectopexy compared with perineal rectosigmoidectomy for FTRP in elderly patients. METHODS: Between July 2000 and June 2009, eight consecutive patients (8 women; mean age, 71 (range, 65-77) years) with FTRP underwent laparoscopic rectopexy (LAP group). During the same period, 143 patients underwent perineal rectosigmoidectomy (PRS group). A total of 123 patients were selected who underwent perineal rectosigmoidectomy (117 women; mean age, 80.7 (range, 66-98) years). RESULTS: Three patients (37.5%) in the LAP group and 29 patients (23.6%) in the PRS group had undergone previous operations for rectal prolapse. The mean follow-up periods were 6.9 months and 12.8 months, respectively. In the LAP group, operative time was longer (166.5 vs. 73.5 minutes; p > 0.05) and bleeding loss was more (101.7 vs. 31.6; p < 0.05), whereas the length of hospitalization was same between the two groups (5.4 vs. 5.3 days; p > 0.05). Postoperative complications included an incisional hernia in the LAP group (12.5%) and urinary retention (4.8%), anastomotic disruption (2.4%), urinary tract infection (1.6%), and atelectasis (1.6%) in the PRS group (13.8%). Recurrences were 1 (12.5%) in the LAP group and 14 (11.4%) in the PRS group. CONCLUSIONS: Laparoscopic rectopexy is a safe and feasible procedure in elderly patients with FTRP but results in increased operative time.

Restorative proctectomy with ileal pouch-anal anastomosis in obese patients.

PURPOSE: The aim of this study was to assess outcomes of ileal pouch-anal anastomosis in obese patients compared with a matched cohort of nonobese patients. METHODS: A review of all obese patients who underwent ileal pouch-anal anastomosis from 1998 to 2008 was performed. Obesity was defined as body mass index >or=30 kg/m. A matched control group of patients with body mass index within 18.5 to 25 kg/m was created. Primary end points included operative time, length of hospital stay, operative blood loss, and early (6 wk) postoperative complications. RESULTS: Sixty-five obese patients (mean body mass index, 34.3 +/- 0.51 kg/m) underwent proctectomy with ileal pouch-anal anastomosis or proctocolectomy with ileal pouch-anal anastomosis. Mean body mass index of the control group was 22.45 +/- 0.2 kg/m (P < .0001). The most common diagnosis was mucosal ulcerative colitis (84.6%), followed by familial adenomatous polyposis (13.9%) and Crohn's disease (1.5%). The obese population had a higher incidence of cardiorespiratory comorbidities (P = .044), and a trend for steroid and immunosuppressive therapy (P = .06) preoperatively. Obese patients required longer operative time (P = .001) and longer hospital stay (P = .009). Early postoperative complications were comparable (P > .05). Long-term outcomes were also similar, except for a higher incidence of incisional hernia in the obese group (P = .01). CONCLUSIONS: The overall postoperative complication rate in obese patients undergoing ileal pouch-anal anastomosis was similar to a matched nonobese cohort of patients. However, longer operative time, longer length of stay, and a higher rate of incisional hernia were noted in the obese population. Obese patients should be appropriately consulted about these issues before undergoing ileal pouch-anal anastomosis.

Laparoscopic surgery for inflammatory bowel disease: does weight matter?

BACKGROUND: Recent studies have shown improved outcomes after laparoscopic colorectal surgery compared with laparotomy for surgery for both benign and malignant colorectal diseases, including inflammatory bowel disease (IBD). This study was designed to evaluate the results of laparoscopic colorectal resections in normal weight patients compared with overweight and obese patients with IBD. METHODS: A retrospective analysis of a prospectively acquired institutional review board-approved surgical database was performed. All consecutive patients with IBD who underwent laparoscopy from January 1, 2000 to April 30, 2008 were reviewed. BMI, age, gender, comorbidities, ASA classification, and surgical- and disease-related variables, including 60-day postoperative complications, were reviewed. Chi-square, Mann-Whitney U test, and Student's t test were used for statistical analysis. RESULTS: A total of 261 patients with IBD underwent laparoscopy: 48 were excluded and 213 were analyzed. Group I comprised 127 normal-weight patients (body mass index (BMI), 18.5-24.9 kg/m(2)), and group II included 67 overweight patients (BMI, 25-29.9 kg/m(2)) and 19 obese patients (BMI >or= 30 kg/m(2)). Crohn's disease was diagnosed in 86 (67.7%) patients in group I and 52 (60.4%) in group II. Procedures performed included ileocolic resection in 56% of patients in each group. Total colectomy with or without proctectomy was undertaken in 39.4% in group I and 40.7% in group II. The conversion rate was 18% for group I and 22.09% for group II (p > 0.005; not significant). The most common reason for conversion was failure to progress due to adhesions or phlegmon. There were no differences in major postoperative complication rates (wound infection, abscess, anastomotic leakage, or small-bowel obstruction) or mean hospital stay (6.7, 6.8, respectively), and there was no mortality. CONCLUSIONS: Patients with IBD who were overweight or obese and who underwent laparoscopic bowel resection had no significant differences in the rates of conversion, major postoperative complications, or length of stay when comparing to patients with normal BMI. Therefore, the benefits of laparoscopic bowel resection should not be denied to overweight or obese patients based strictly on their BMI.