Guillain-Barré syndrome as an early manifestation of angioimmunoblastic T-cell lymphoma.

Guillain-Barré syndrome (GBS) is a rare condition caused by autoimmune damage of peripheral nerves. We describe a case where a man in his 80s presented with subacute, progressive fatigue and weakness. He had received an outpatient work-up for possible haematological malignancy, but eventually presented to the emergency department for worsening weakness. A physical exam and cerebrospinal fluid analysis suggested a diagnosis of GBS. Subsequently, a pathological diagnosis of angioimmunoblastic T-cell lymphoma was made. The patient underwent intravenous immunoglobulin treatment for GBS and was started on cyclophosphamide, doxorubicin, vincristine and prednisone therapy. Prior research has suggested that incident malignancy may be associated with GBS, which may be caused by a paraneoplastic-type phenomenon, malignancy-associated immune dysregulation or an autoimmune reaction triggered by a common exposure. Clinicians should be aware of the possible association between these two conditions and should remain open minded to the possibility of non-infectious triggers for GBS.

Effect of intraperitoneal local anesthesia on enhanced recovery outcomes after bariatric surgery: a randomized controlled pilot study.

BACKGROUND: Patients with extreme obesity are at high risk for adverse perioperative events, especially when opioid-centric analgesic protocols are used, and perioperative pain management interventions in bariatric surgery could improve safety, outcomes and satisfaction. We aimed to evaluate the impact of intraperitoneal local anesthesia (IPLA) on enhanced recovery after bariatric surgery (ERABS) outcomes. METHODS: We conducted a prospective double-blind randomized controlled pilot study in adherence to an a priori peer-reviewed protocol. Patients undergoing laparoscopic Roux-en-Y gastric bypass surgery (LRYGB) with an established ERABS protocol between July 2014 and February 2015 were randomly allocated to receive either IPLA with 0.2% ropivacaine (intervention group) or normal saline (control group). We measured pain scores, analgesic consumption and adverse effects. Functional prehabilitation outcomes, including peak expiratory flow (PEF) and the Six Minute Walk Test (6MWT) and Quality of Recovery Survey-40 (QoR-40) scores, were assessed before surgery, and 1 day and 7 days postoperatively. RESULTS: One hundred patients were randomly allocated to the study groups, of whom 92 completed the study, 46 in each group. There were no statistically significant differences between the 2 groups in baseline characteristics or any primary or secondary outcomes. Pain scores and analgesic consumption were low in both groups. There were no adverse events. Significant declines in PEF and 6MWT and QoR-40 scores were noted on postoperative day 1 in both groups; the values returned to baseline on postoperative day 7 in both groups. CONCLUSION: Intraperitoneal local anesthesia with ropivacaine did not reduce postoperative pain or analgesic consumption when administered intraoperatively to patients undergoing LRYGB. Standardization of the ERABS protocol benefited patients, with functional prehabilitation outcomes returning to baseline postoperatively. Trial registration: ClinicalTrials.gov no. NCT02154763.

Impact of an internal medicine nocturnist service on care of patients with cancer at a large Canadian teaching hospital: a quality-improvement study.

BACKGROUND: Nocturnists (overnight hospitalists) are commonly implemented in US teaching hospitals to adhere to per-resident patient caps and improve care but are rare in Canada, where patient caps and duty hours are comparatively flexible. Our objective was to assess the impact of a newly implemented nocturnist program on perceived quality of care, code status documentation and patient outcomes. METHODS: Nocturnists were phased in between June 2018 and December 2019 at Toronto General Hospital, a large academic teaching hospital in Toronto, Ontario. We performed a quality-improvement study comparing rates of code status entry into the electronic health record at admission, in-hospital mortality, the 30-day readmission rate and hospital length of stay for patients with cancer admitted by nocturnists and by residents. Surveys were administered in June 2019 to general internal medicine faculty and residents to assess their perceptions of the impact of the nocturnist program. RESULTS: From July 2018 to June 2019, 30 nocturnists were on duty for 241/364 nights (66.5%), reducing the mean maximum overnight per-resident patient census from 40 (standard deviation [SD] 4) to 25 (SD 5) (p < 0.001). The rate of admission code status entry was 35.3% among patients admitted by residents (n = 133) and 54.9% among those admitted by nocturnists (n = 339) (p < 0.001). The mortality rate was 10.5% among patients admitted by residents and 5.6% among those admitted by nocturnists (p = 0.06), the 30-day readmission rate was 8.3% and 5.9%, respectively (p = 0.4), and the mean acute length of stay was 7.2 (SD 7.0) days and 6.4 (SD 7.8) days, respectively (p = 0.3). Surveys were completed by 15/24 faculty (response rate 62%), who perceived improvements in patient safety, efficiency and trainee education; however, only 30/102 residents (response rate 29.4%) completed the survey. INTERPRETATION: Although implementation of a nocturnist program did not affect patient outcomes, it reduced residents' overnight patient census, and improved faculty perceptions of quality of care and education, as well as documentation of code status. Our results support nocturnist implementation in Canadian teaching hospitals.

A Patient Decision Aid for Men With Localized Prostate Cancer: A Comparative Case Study of Natural Implementation Approaches.

BACKGROUND: There are multiple options for men diagnosed with localized prostate cancer. Patient decision aids (PtDAs) help empower individuals and reduce unwarranted practice variation, but few are used in clinical practice. OBJECTIVE: We compared 2 programs implementing PtDAs for men with localized prostate cancer. METHODS: This was a comparative case study. Case 1 was a hospital prostate pathway and case 2 was a provincial prostate pathway with 2 locations (2a, 2b). Nurses provided the men with PtDAs and answered questions. Data sources were as follows: (a) 2 years administrative data for men with localized prostate cancer, (b) clinicians survey and interviews, and (c) patients/spouses interviews. Analysis was within and across cases. RESULTS: The PtDA was used with 23% of men in case 1 (95% confidence interval, 19.8%-26.1%) and 98% of men in case 2a (95% confidence interval, 96.5%-99.8%). The pathway was not implemented in case 2b. Men given the PtDA had positive experiences. Many clinicians supported the use of PtDAs, some adapted their discussions with patients, and others did not support the use of PtDAs. To increase use in case 1, participants identified needing a Canadian PtDA available electronically and endorsed by all clinicians. In case 2b, the provincial prostate pathway needed to be implemented. CONCLUSIONS: There was variable uptake of the PtDAs between the cases. Men who received the PtDA had positive outcomes. Several strategies were identified to increase or sustain PtDA use. IMPLICATIONS FOR PRACTICE: Nurses have a key role in supporting men making decisions about prostate cancer treatment by providing PtDAs, answering questions, and advocating for men's preferences.

Transversus Abdominis Plane Block in Laparoscopic Colorectal Surgery: A Systematic Review.

BACKGROUND: Multimodal analgesia is important for postoperative recovery in laparoscopic colorectal surgery. Multiple randomized controlled trials have investigated the use of transversus abdominis plane local anesthetic infiltration as a method of decreasing postoperative pain and opioid consumption, with variable results. OBJECTIVE: This study aimed to examine the overall effect of transversus abdominis plane block in postoperative pain, opioid use, and speed of recovery in laparoscopic colorectal surgery. DATA SOURCES: A literature search was done with PubMed, EMBASE, Web of Knowledge, and Cochrane Library. Only randomized controlled trials were selected for review. INTERVENTIONS: Transversus abdominis plane local anesthetic infiltration versus no intervention, saline, or other techniques in laparoscopic colorectal surgeries was investigated. MAIN OUTCOME MEASURES: The primary outcome measured was postoperative pain on day 1, at rest or with activity. The secondary outcomes measured were postoperative pain beyond day 1, consumptions of opioid, and length of hospital stay. RESULTS: Eight clinical trials including 649 patients between 2013 and 2018 were included. Resting pain scores within 2 hours (standardized mean difference, -0.53; p = 0.01), 4 hours (standardized mean difference, -0.42; p = 0.004), and 6 hours (standardized mean difference, -0.47; p = 0.03) showed statistically significant reduction. Six studies including 413 patients demonstrated lower cumulative opioid consumption within 24 hours after surgery (standardized mean difference, -0.82; p = 0.01). Five studies including 357 patients did not show a significant difference in length of stay (standardized mean difference, -0.04; p = 0.82). LIMITATIONS: Local anesthetic used in block varied in type and quantity across different studies. There were heterogeneities in pain score measurements and opioid consumption. Patient populations may be different among studies. CONCLUSIONS: Transversus abdominis block can lead to a lower pain score at rest within the first 6 hours and reduce opioid consumption within the first 24 hours. See Video Abstract at http://links.lww.com/DCR/A997.

Tumor mutation burden, DNA mismatch repair status and checkpoint immunotherapy markers in primary and relapsed malignant rhabdoid tumors.

INTRODUCTION: Malignant rhabdoid tumor (MRT) is a rare, aggressive pediatric tumor of nuclear lineage. It is mainly characterized by germline or somatic SMARCB1 (INI1) driver mutations. To characterize the potential for immunotherapy in untreated and treated MRT, current study investigated tumor mutational burden (TMB) and other biomarkers in MRT. MATERIAL AND METHODS: Normal-tumor paired whole exome sequencing (WES) and/or immunohistochemistry (IHC) of DNA mismatch repair (MMR) proteins, PD-L1, PD-1 and CD8 were performed in 16 cases, some with both primary and relapsed tumor. RESULTS: Five cases subjected to WES demonstrated germline SMARCB1 (INI1) mutations. TMB was 0.7-1.07/Mb in 4 of the 5 primary untreated tumors, and 33.81/Mb in one case with pathogenic MMR, POLD, and POLE mutations. Ten cases tested for MMR status by IHC showed retained nuclear expression of the proteins. Eight of the 16 cases (8/16, 50%) showed membranous expression of PD-L1 in 10-70% of tumor cells (tumor proportion score, TPS). Nine cases (9/16, 56.3%) showed high (>2/HPF) tumor infiltrating lymphocytes with PD-1 staining ranging 10-60%, correlating with tumor PD-L1 staining (p < 0.0001). Between post-treatment metastatic tumors and the pre-treatment primary tumors, TMB was similar while PD-L1 TPS was similar or lower. CONCLUSION: MRT has a low TMB. Nonetheless, because a subset of MRT cases have a PD-L1 TPS greater than the cutoff for checkpoint therapy in other malignancies, the utility of immune checkpoint inhibitors should be studied in this patient population.

Cryo-EM structure of substrate-bound human telomerase holoenzyme.

The enzyme telomerase adds telomeric repeats to chromosome ends to balance the loss of telomeres during genome replication. Telomerase regulation has been implicated in cancer, other human diseases, and ageing, but progress towards clinical manipulation of telomerase has been hampered by the lack of structural data. Here we present the cryo-electron microscopy structure of the substrate-bound human telomerase holoenzyme at subnanometre resolution, showing two flexibly RNA-tethered lobes: the catalytic core with telomerase reverse transcriptase (TERT) and conserved motifs of telomerase RNA (hTR), and an H/ACA ribonucleoprotein (RNP). In the catalytic core, RNA encircles TERT, adopting a well-ordered tertiary structure with surprisingly limited protein-RNA interactions. The H/ACA RNP lobe comprises two sets of heterotetrameric H/ACA proteins and one Cajal body protein, TCAB1, representing a pioneering structure of a large eukaryotic family of ribosome and spliceosome biogenesis factors. Our findings provide a structural framework for understanding human telomerase disease mutations and represent an important step towards telomerase-related clinical therapeutics.

Endogenous Telomerase Reverse Transcriptase N-Terminal Tagging Affects Human Telomerase Function at Telomeres In Vivo.

Telomerase action at telomeres is essential for the immortal phenotype of stem cells and the aberrant proliferative potential of cancer cells. Insufficient telomere maintenance can cause stem cell and tissue failure syndromes, while increased telomerase levels are associated with tumorigenesis. Both pathologies can arise from only small perturbation of telomerase function. To analyze telomerase at its low endogenous expression level, we genetically engineered human pluripotent stem cells (hPSCs) to express various N-terminal fusion proteins of the telomerase reverse transcriptase from its endogenous locus. Using this approach, we found that these modifications can perturb telomerase function in hPSCs and cancer cells, resulting in telomere length defects. Biochemical analysis suggests that this defect is multileveled, including changes in expression and activity. These findings highlight the unknown complexity of telomerase structural requirements for expression and function in vivo.

Implementation of a patient decision aid for men with localized prostate cancer: evaluation of patient outcomes and practice variation.

BACKGROUND: Men with localized prostate cancer often have unrealistic expectations. Practitioners are poor judges of men's preferences, contributing to preference misdiagnosis and unwarranted practice variation. Patient decision aids (PtDAs) can support men with decisions about localized prostate cancer. This is a comparative case study of two strategies for implementing PtDAs in clinical pathways for men with localized prostate cancer, evaluating (a) PtDA use; (b) impact on men, practitioners, and health system outcomes; and (c) factors influencing sustained use. METHODS/DESIGN: Guided by the Knowledge to Action Framework, this comparative case study will be conducted using administrative data, interviews, and surveys. Cases will be bound by geographic location (one hospital in Ontario; province of Saskatchewan) and time. Eligible participants will be all men newly diagnosed with localized prostate cancer, with outcomes assessed using administrative data and interviews. Nurses, urologists, radiation oncologists, and managers will be surveyed and a smaller sample interviewed. Cases will be established for each setting with findings compared across cases. Changes in the proportions of men given the PtDA over 2 years will be determined from administrative data. Factors associated with receiving the PtDA will be explored using multivariable logistic regression analysis. To assess the impact of the PtDA, outcomes will be described using mean and standard deviation (men's decisional conflict) and frequency and proportions (practitioners consulted, uptake of treatment). To estimate the effect of the PtDA on these outcomes, adjusted mean differences and odds ratios will be calculated using exploratory multivariable general linear regression and binary or multinomial logistic regression. Factors influencing sustained PtDA use will be assessed using descriptive analysis of survey findings and thematic analysis of interview transcripts. DISCUSSION: Determining how to embed PtDAs effectively within clinical pathways for men with localized prostate cancer is essential. PtDAs have the potential to strengthen men's active role in making prostate cancer decisions, enhance uptake of shared decision-making by practitioners, and reduce practice variation. Our team of researchers and knowledge users will use findings to improve current PtDA use and consider scaling-up implementation.

Evaluation of the Rectal Cancer Patient Decision Aid: A Before and After Study.

BACKGROUND: In rectal cancer surgery, low anterior resection and abdominoperineal resection have equivocal impact on overall quality of life. A rectal cancer decision aid was developed to help patients weigh features of options and share their preference. OBJECTIVE: The aim of this study was to evaluate the effect of a patient decision aid for mid to low rectal cancer surgery on the patients' choice and decision-making process. DESIGN: A before-and-after study was conducted. Baseline data collection occurred after surgeon confirmation of eligibility at the first consultation. Patients used the patient decision aid at home (online and/or paper-based formats) and completed post questionnaires. SETTING: This study was conducted at an academic hospital referral center. PATIENTS: Adults who had rectal cancer at a maximum of 10 cm proximal to the anal verge and were amenable to surgical resection were considered. Those with preexisting stoma and those only receiving abdominoperineal resection for technical reasons were excluded from the study. INTERVENTION: Patient with rectal cancer were provided with a decision aid. MAIN OUTCOME MEASURES: The primary outcomes measured were decisional conflict, knowledge, and preference for a surgical option. RESULTS: Of 136 patients newly diagnosed with rectal cancer over 13 months, 44 (32.4%) were eligible, 36 (81.9%) of the eligible patients consented to participate, and 32 (88.9%) patients completed the study. The mean age of participants was 61.9 ± 9.7 years and tumor location was on average 7.3 ± 2.1 cm above the anal verge. Patients had poor baseline knowledge (52.5%), and their knowledge improved by 37.5% (p < 0.0001) after they used the patient decision aid. Decisional conflict was reduced by 24.2% (p = 0.0001). At baseline, no patients preferred a permanent stoma, and after decision aid exposure, 2 patients (7.1%) preferred permanent stoma. Over 96% of participants would recommend the patient decision aid to others. LIMITATIONS: This study was limited by the lack of control for potential confounders and potential response bias. CONCLUSIONS: The patient decision aid reduced decisional conflict and improved patient knowledge. Participants would recommend it to other patients with rectal cancer.

Patient Preferences for Test Result Notification.

IMPORTANCE: Patients are increasingly being given access to their test results, but little is known about how preferences vary with the test under consideration or the results of the test (normal or abnormal). OBJECTIVE: This study was conducted to examine preferences for test result communication. DESIGN, SETTING, AND PARTICIPANTS: We surveyed adults to explore their preferences for test result notification for three common diagnostic tests of varying "emotional impact" (dual-energy x-ray absorptiometry [DXA], genital herpes, and cancer biopsy) when test results were 1) normal and 2) abnormal. We conducted our survey between June and August 2012 on the campus of an academic medical center. For each scenario, subjects were asked to rank seven methods that might be used to communicate test results (letter, unsecured email, secured email, text message, telephone call, secure Web portal, office visit) in order of acceptability. MAIN OUTCOME MEASURES: The main measures were the percentage of respondents who ranked a particular test result notification method favorably and the percentage who ranked it as unacceptable. RESULTS: When test results were normal, subjects' notification preferences were generally similar for DXA, herpes and cancer biopsy, with telephone and letter ranked most favorably for all three tests. Conversely, text message and unsecured email were viewed as unacceptable notification methods for normal results by 45.0-55.0 % of subjects across all three tests. When test results were abnormal, office visits became more popular. A higher proportion of subjects ranked office visits as their most preferred notification method for our test with high "emotional impact" (cancer biopsy) (38.4 %) as compared to DXA (28.2 %) and herpes (27.9 %) (P = 0.02). For most test scenarios, younger subjects appeared to rank electronic communication modalities (secure email or Web portal) higher than older subjects, though this difference did not reach statistical significance (P = 0.29). CONCLUSIONS: Preferences for test result notification can differ substantially depending upon the test under consideration and results of the test. Providers and health care systems should consider these factors when deciding how to communicate results to patients.

Dynamic article: combined endoscopic-laparoscopic surgery for complex colonic polyps: postoperative outcomes and video demonstration of 3 key operative techniques.

BACKGROUND: Combined endoscopic-laparoscopic surgery is a novel technique that can be used to avoid bowel resection for complex colon polyps that are not amenable to colonoscopic resection. OBJECTIVE: The aim of this study was to evaluate the safety and outcomes of combined endoscopic-laparoscopic surgery for complex colonic polyps. DESIGN: This study is a retrospective review of consecutive combined endoscopic-laparoscopic surgeries. SETTING: This study was conducted at a single institution. PATIENTS: All patients that underwent combined endoscopic-laparoscopic surgery for a complex colonic polyp at our center from October 2009 to October 2013 were followed. Each patient's lesion was assessed by a therapeutic endoscopist before referral for combined endoscopic-laparoscopic surgery, and was deemed unresectable based on size, broad base, or location of the polyp. MAIN OUTCOME MEASURES: Intraoperative and postoperative complications, length of hospital stay, and recurrence were the primary outcomes measured. RESULTS: Thirty consecutive patients underwent combined endoscopic-laparoscopic surgery. Twenty (66.7%) patients underwent laparoscopic-assisted colonoscopic polyp excision (10 of these excisions were facilitated by Endoloop placement at the polyp base), 9 (30%) patients underwent colonoscopic-assisted laparoscopic cecectomy, and 1 (3.3%) patient was converted from a colonoscopic-assisted laparoscopic cecectomy to a laparoscopic ileocolic resection. The median length of hospital stay was 2 days (range, 1-16). Twenty-nine (96.7%) of the final pathology results were benign, with 10 (33.3%) showing high-grade dysplasia. One (3.3%) final pathology result was positive for a well-differentiated adenocarcinoma. This patient subsequently underwent a laparoscopic right hemicolectomy and chemotherapy for node-positive disease. One (3.3%) patient experienced a recurrent benign polyp at the previous excision site, which was removed by colonoscopy. The time to detection of recurrence was 274 days. LIMITATIONS: This study looked at a small group of patients, over a short follow-up period. However, all consecutive patients were captured, and there were no losses to follow-up. CONCLUSIONS: Combined endoscopic-laparoscopic surgery for complex benign colonic polyps is a safe procedure, with good clinical outcomes and low recurrence rates.

Laparoscopic peritoneal dialysis catheter insertion using nitrous oxide under procedural sedation.

BACKGROUND: Laparoscopic peritoneal dialysis catheter (LPDC) implantation using nitrous oxide (N2O) pneumoperitoneum under procedural sedation is a technique that has many advantages over conventional insertion methods. The purpose of this study was to review the LPDC insertion results at our center. METHODS: Data from 87 consecutive patients who underwent LPDC insertion was retrospectively reviewed. All procedures were attempted under procedural sedation. After patients received intravenous and local anesthesia, a N2O pneumoperitoneum was established. Peritoneal dialysis (PD) catheters were advanced using rectus sheath tunneling. The position of the catheter was confirmed by laparoscope, and adjunct procedures such as omentopexy and adhesiolysis were performed on select patients to prevent catheter flow problems. RESULTS: Nitrous oxide was well tolerated by 94 % of the patients. Only five patients required conversion to general anesthesia. After a mean follow-up of 18.2 months, mechanical complications included pericatheter/incision leakage (12.62 %), flow obstruction (4.60 %), incision/exit site hernia (3.45 %), hemoperitoneum (2.30 %), pleuroperitoneal fistula (1.15 %), scrotal leak (1.15 %), and migration (1.15 %). Infectious complications included exit site infection (1 episode per 312.95 patient-months) and peritonitis (1 episode per 31.93 patient-months). Revision-free catheter survival was 97.6 % after 1 year. CONCLUSION: Laparoscopic implantation of a PD catheter with N2O pneumoperitoneum and local anesthesia is safe and effective in patients with severe renal failure. N2O is an inert gas and better tolerated as an insufflation agent, enabling awake procedures. Our results show that catheter-related functional outcomes are comparable to those in the existing literature. This approach can be recommended as a good option for catheter implantation in patients needing dialysis.

Mortality trends in women and men with COPD in Ontario, Canada, 1996-2012.

IMPORTANCE: COPD is the third leading cause of death worldwide. Mortality trends offer an indication of how well a society is doing in fighting a disease. OBJECTIVE: To examine trends in all-cause, lung cancer, cardiovascular and COPD mortalities in people with COPD, overall and in men and women. DESIGN, SETTING, PARTICIPANTS: Population, cohort study using health administrative data from Ontario, Canada, 1996 to 2011. EXPOSURE: A previously validated COPD case definition was used to identify all people with COPD. MAIN OUTCOMES AND MEASURES: All-cause, lung cancer, cardiovascular and COPD mortality rates were determined annually from 1996 to 2011 overall, and in men and women. All-cause trends were compared with all-cause trends in the non-COPD population. All rates were standardised to the 2006 Ontario population. RESULTS: The prevalence of COPD was 11.0% in 2011. Over the study period, all-cause mortality decreased significantly more in men with COPD than the non-COPD population. The same was not observed in women. COPD-specific and lung cancer mortalities, which started higher in men with COPD, decreased faster in them than in women with COPD with the two rates becoming more similar over time. Cardiovascular disease mortality declined at a relatively equal rate in both sexes. CONCLUSIONS AND RELEVANCE: Mortality in people with COPD has decreased; however, the decrease has been greater in men than in women. Public health interventions and medical care appear to be improving mortality in individuals with COPD but more research is needed to determine if they are benefiting both sexes equally.

Autologous Fat Grafting as a Novel Approach to Parastomal Soft-tissue Volume Deficiencies.

SUMMARY: The aim of this study is to describe a novel approach to revise maladaptive soft-tissue contour around an ileostomy. A patient with permanent ileostomy suffered from significant defects in soft-tissue contour due to scarring and wound contraction. He underwent autologous fat grafting to achieve sealing of his stoma appliance and improve cosmesis. Due to numerous surgeries, the stoma appliance would not seal and required daily appliance changes. The patient received autologous fat grafting to augment the contour around stoma. A complete fitting of stoma was achieved. The patient is satisfied with stoma sealing and is changing his stoma appliance every 5-7 days without skin excoriation. Autologous fat transfer is an effective approach to treat a subset of stoma patients with complex subcutaneous defects.

Assessing the feasibility of a randomised, double-blinded, placebo-controlled trial to investigate the role of intraperitoneal ropivacaine in gastric bypass surgery: a protocol.

INTRODUCTION: Postoperative pain control remains a major challenge for surgical procedures, including laparoscopic gastric bypass. Pain management is particularly relevant in obese patients who experience a higher number of cardiovascular and pulmonary events. Effective pain management may reduce their risk of serious postoperative complication, such as deep vein thrombosis and pulmonary emboli. The objective of this study is to evaluate the efficacy of intraperitoneal local anaesthetic, ropivacaine, to reduce postoperative pain in patients undergoing laparoscopic Roux-en-Y gastric bypass. METHODS AND ANALYSIS: A randomised controlled trial will be conducted to compare intraperitoneal ropivacaine (intervention) versus normal saline (placebo) in 120 adult patients undergoing bariatric bypass surgery. Ropivacaine will be infused over the oesophageal hiatus and throughout the abdomen. Patients in the control arm will undergo the same treatment with normal saline. The primary end point will be postoperative pain at 1, 2 and 4 h postoperatively. Pain measurements will then occur every 4 h for 24 h and every 8 h until discharge. Secondary end points will include opioid use, peak expiratory flow, 6 min walk distance and quality of life assessed in the immediate postoperative period. Intention-to-treat analysis will be used and repeated measures will be analysed using mixed modelling approach. Post-hoc pairwise comparison of the treatment groups at different time points will be carried out using multiple comparisons with adjustment to the type 1 error. Results of the study will inform the feasibility of recruitment and inform sample size of a larger definitive randomised trial to evaluate the effectiveness of intraperitoneal ropivacaine. ETHICS AND DISSEMINATION: This study has been approved by the Ottawa Health Science Network Research Ethics Board and Health Canada in April 2014. The findings of the study will be disseminated through national and international conferences and peer-reviewed journals. TRIAL REGISTRATION NUMBER: Clinicaltrial.gov NCT02154763.

Reporting quality of statistical methods in surgical observational studies: protocol for systematic review.

BACKGROUND: Observational studies dominate the surgical literature. Statistical adjustment is an important strategy to account for confounders in observational studies. Research has shown that published articles are often poor in statistical quality, which may jeopardize their conclusions. The Statistical Analyses and Methods in the Published Literature (SAMPL) guidelines have been published to help establish standards for statistical reporting.This study will seek to determine whether the quality of statistical adjustment and the reporting of these methods are adequate in surgical observational studies. We hypothesize that incomplete reporting will be found in all surgical observational studies, and that the quality and reporting of these methods will be of lower quality in surgical journals when compared with medical journals. Finally, this work will seek to identify predictors of high-quality reporting. METHODS/DESIGN: This work will examine the top five general surgical and medical journals, based on a 5-year impact factor (2007-2012). All observational studies investigating an intervention related to an essential component area of general surgery (defined by the American Board of Surgery), with an exposure, outcome, and comparator, will be included in this systematic review. Essential elements related to statistical reporting and quality were extracted from the SAMPL guidelines and include domains such as intent of analysis, primary analysis, multiple comparisons, numbers and descriptive statistics, association and correlation analyses, linear regression, logistic regression, Cox proportional hazard analysis, analysis of variance, survival analysis, propensity analysis, and independent and correlated analyses. Each article will be scored as a proportion based on fulfilling criteria in relevant analyses used in the study. A logistic regression model will be built to identify variables associated with high-quality reporting. A comparison will be made between the scores of surgical observational studies published in medical versus surgical journals. Secondary outcomes will pertain to individual domains of analysis. Sensitivity analyses will be conducted. DISCUSSION: This study will explore the reporting and quality of statistical analyses in surgical observational studies published in the most referenced surgical and medical journals in 2013 and examine whether variables (including the type of journal) can predict high-quality reporting.

The evaluation of a rectal cancer decision aid and the factors influencing its implementation in clinical practice.

BACKGROUND: Colorectal cancer is common in North America. Two surgical options exist for rectal cancer patients: low anterior resection with re-establishment of bowel continuity, and abdominoperineal resection with a permanent stoma. A rectal cancer decision aid was developed using the International Patient Decision Aid Standards to facilitate patients being more actively involved in making this decision with the surgeon. The overall aim of this study is to evaluate this decision aid and explore barriers and facilitators to implementing in clinical practice. METHODS: First, a pre- and post- study will be guided by the Ottawa Decision Support Framework. Eligible patients from a colorectal cancer center include: 1) adult patients diagnosed with rectal cancer, 2) tumour at a maximum of 10 cm from anal verge, and 3) surgeon screened candidates eligible to consider both low anterior resection and abdominoperineal resection. Patients will be given a paper-version and online link to the decision aid to review at home. Using validated tools, the primary outcomes will be decisional conflict and knowledge of surgical options. Secondary outcomes will be patient's preference, values associated with options, readiness for decision-making, acceptability of the decision aid, and feasibility of its implementation in clinical practice. Proposed analysis includes paired t-test, Wilcoxon, and descriptive statistics. Second, a survey will be conducted to identify the barriers and facilitators of using the decision aid in clinical practice. Eligible participants include Canadian surgeons working with rectal cancer patients. Surgeons will be given a pre-notification, questionnaire, and three reminders. The survey package will include the patient decision aid and a facilitators and barriers survey previously validated among physicians and nurses. Principal component analysis will be performed to determine common themes, and logistic regression will be used to identify variables associated with the intention to use the decision aid. DISCUSSION: This study will evaluate the impact of the rectal cancer decision aid on patients and help with planning strategies to overcome barriers and facilitate implementation of the decision aid in routine clinical practice. To our knowledge this is the first study designed to evaluate a decision aid in the field of colorectal surgery.