Association between Complications and Death within 30 days after General Surgery: A Vascular Events in Noncardiac Surgery Patients Cohort Evaluation (VISION) substudy.

OBJECTIVE: To determine the epidemiology of post-operative complications among general surgery patients, inform their relationships with 30-day mortality, and determine the attributable fraction of death of each postoperative complication. BACKGROUND: The contemporary causes of post-operative mortality among general surgery patients are not well characterized. METHODS: VISION is a prospective cohort study of adult non-cardiac surgery patients across 28 centres in 14 countries, who were followed for 30 days after surgery. For the subset of general surgery patients, a cox proportional hazards model was used to determine associations between various surgical complications and post-operative mortality. The analyses were adjusted for preoperative and surgical variables. Results were reported in adjusted hazard ratios (HR) with 95% confidence intervals (CI). RESULTS: Among 7950 patients included in the study, 240 (3.0%) patients died within 30 days of surgery. Five post-operative complications (myocardial injury after non-cardiac surgery [MINS], major bleeding, sepsis, stroke, and acute kidney injury resulting in dialysis) were independently associated with death. Complications associated with the largest attributable fraction (AF) of post-operative mortality (i.e., percentage of deaths in the cohort that can be attributed to each complication, if causality were established) were major bleeding (n=1454, 18.3%, HR 2.49 95%CI 1.87-3.33, P<0.001, AF 21.2%), sepsis (n=783, 9.9%, HR 6.52, 95%CI 4.72-9.01, P<0.001, AF 15.6%), and MINS (n=980, 12.3%, HR 2.00, 95%CI 1.50-2.67, P<0.001, AF 14.4%). CONCLUSION: The complications most associated with 30-day mortality following general surgery are major bleeding, sepsis, and MINS. These findings may guide the development of mitigating strategies, including prophylaxis for perioperative bleeding.

Assessing the Modified Frailty Index and Post-Operative Outcomes in Adhesive Small Bowel Obstruction: A Retrospective Cohort Study.

INTRODUCTION: Studies identifying predictors of postoperative outcomes in adhesive small bowel obstruction are limited. This study investigates the efficacy of the modified frailty index (mFI)to predict postoperative morbidity and mortality among patients undergoing surgery for adhesive small bowel obstruction. METHODS: A multicentre retrospective cohort study including patients undergoing surgery for adhesive small bowel obstruction after failed trial of nonoperative management between January 2015 and December 2020 was performed. Impact of frailty status using the mFI, stratified as frail (≥0.27) and robust (<0.27), on postoperative morbidity, mortality, length of stay, and discharge destination was evaluated using multiple logistic regression. RESULTS: Ninety-two robust patients (mean age 62.4 y, 68% female) and 41 frail patients (mean age 81.7 y, 63% female) were included. On simple stratification, frail patients had significantly increased 30-d morbidity (overall morbidity 80% versus 49%) and need for higher level of care on discharge (41% versus 9%). However, on multiple regression, functional dependence but not the mFI, was independently associated with worse 30-d overall morbidity (odds ratio [OR] 3.97, confidence interval [CI] 1.29-12.19) and lower likelihood of returning to preoperative disposition (OR 0.21, CI 0.05-0.91). The delay in operation beyond 5 d was independently associated with worse 30-d outcomes including overall morbidity and mortality (OR 7.54, CI 2.13-26.73) and decreased return to preoperative disposition (OR 0.14, CI 0.04-0.56). CONCLUSIONS: The mFI, although promising, was not independently predictive of outcomes following surgery for adhesive small bowel obstruction. Further adequately powered studies are required.

Patient reported symptom burden amongst immigrant and Canadian long-term resident women undergoing breast cancer surgery.

PURPOSE: Immigrants are susceptible to marginalization due to social isolation, economic disadvantage and systemic bias. Our goal was to compare symptom burden between immigrant and long-term resident women undergoing breast cancer surgery in Ontario, Canada. METHODS: A population-level retrospective cohort-study using administrative databases was conducted. Women who underwent surgery for newly diagnosed breast cancer and were treated at regional cancer centers between 2010 and 2016 were included. The primary outcome was a moderate or severe (≥ 4) symptom score on the Edmonton Symptom Assessment System Scale (ESAS). RESULTS: There were 12,250 (87.2%) long-term Canadian residents and 1,806(12.8%) immigrants. Immigrants were younger (mean age 53 vs. 61 years); had a higher proportion residing in a lowest income quintile neighbourhood (22.2% vs 15.4%); were less often on a primary-care physician roster (83.7% vs. 90.4%); and were less often diagnosed with Stage I/II disease (80.9% vs. 84.6%) (all p < 0.01). The proportion of women with scores ≥ 4 was significantly higher amongst immigrant women for 7/9 symptom categories; with the largest differences for depression (24.9% vs. 20.2%, p < 0.01) and pain (28.0% vs. 22.4%, p < 0.01). On multivariable regression analysis, immigration status was associated with scores ≥ 4 for pain (OR 1.13, 95% CI 1.02-1.23). There was an association between moderate/severe pain and region of origin, but not length of stay in Canada or immigration class. CONCLUSIONS: This is the first study comparing symptom burden amongst immigrant and non-immigrant women with breast cancer at a population-level. Immigrant women with breast cancer undergoing surgery were found to have a higher burden of pain.

Phyllodes Tumors of the Breast: Canadian National Consensus Document Using Modified Delphi Methodology.

PURPOSE: Phyllodes tumors are rare breast neoplasms with limited prospective data to guide treatment, leading to heterogeneous management of this disease. We developed National consensus statements using modified Delphi methodology including patients and practitioners across Canada. METHODS: Statements were developed based on a literature review. Two iterations of surveys were distributed with a planned virtual consensus meeting. Panelists were invited from surgery, radiation oncology, medical oncology, pathology, radiology, and plastic surgery. RESULTS: Twenty-three participants attended the virtual conference. One hundred statements regarding diagnostics, pathology, surgical planning, adjuvant therapies, recurrence, surveillance, and patient support were approved with an a priori defined consensus of ≥ 80%. Two tables on locoregional management were developed and approved. The management of borderline phyllodes tumors was a source of uncertainty, and recommendations reflect the lack of evidence in this rare presentation. CONCLUSION: A consensus document containing all approved statements for the care and management of phyllodes tumors was developed to help guide practice and future research.

Axillary surgery and complication rates after mastectomy and reconstruction for breast cancer: an analysis of the NSQIP database.

PURPOSE: Some series have shown increased complications with extended nodal surgery and immediate breast reconstruction (IBR) with implants. We aim to explore complications associated with axillary dissection compared to sentinel lymph node biopsy at a population level. METHODS: American College of Surgeons National Surgical Quality Improvement Program participant user files from 2008-2018 were searched to create a cohort of female patients undergoing unilateral mastectomy with IBR and axillary surgery for non-metastatic breast cancer. Patients were classified as having sentinel lymph node biopsy (SLNB), axillary dissection (ALND), or sentinel lymph node biopsy and axillary dissection (SLNB + ALND). Baseline demographics were compared, and multivariable logistic regression was to assess for independent predictors of the primary outcome of 30-day morbidity. RESULTS: Between 2008 and 2018, 18,232 patients had mastectomy and IBR with axillary surgery; 12,632 patients underwent SLNB, 3727 had ALND and 1,873 underwent SLNB + ALND. Mean age of patients in the cohort was 52.5 (SD 11). There was no difference in 30-day morbidity between groups (SLNB: 4.3%, ALND: 4.9%, SLNB + ALND: 4.2%, p = 0.207). Multivariable regression showed that type of axillary surgery was not an independent predictor of 30-day complications (OR 0.78 (95% CI 0.52-1.15) for ALND, and OR 0.87 (95% CI 0.52-1.45) for ALND + SLNB vs SLNB alone). Significant independent predictors for complications were increased BMI (OR 1.06 (95%CI 1.04-1.08)) and increased operative time (OR 1.003 (95% CI 1.001-1.005)). CONCLUSIONS: ALND does not increase 30-day morbidity in patients undergoing IBR when compared to SLNB. This supports concurrent axillary dissection for IBR patients when indicated.

Malignant Bowel Obstruction Management Over Time: Are We Doing Anything New? A Current Narrative Review.

INTRODUCTION: Malignant bowel obstruction from peritoneal carcinomatosis affects a significant proportion of luminal gastrointestinal and ovarian oncology patients, and portends poor long-term survival. The management approach for these patients includes a range of medical therapies and surgical options; however, how to select an optimal treatment strategy remains enigmatic. The goal of this narrative review was to summarize the latest evidence around multimodal malignant bowel obstruction treatment and to establish if and where progress has been made. METHODS: A targeted literature search examining articles focused on the management of malignant bowel obstruction from peritoneal carcinomatosis was performed. Following data extraction, a narrative review approach was selected to describe evidence and guidelines for surgical prognostic factors, imaging, tube decompression, medical management, nutrition, and quality of life. RESULTS: Outcomes in the literature to date are summarized for various malignant bowel obstruction treatment strategies, including surgical and non-surgical approaches, as well as a discussion of the role of total parenteral nutrition and chemotherapy in holistic malignant bowel obstruction management. CONCLUSION: There has been little change in survival outcomes in malignant bowel obstruction in over more than a decade and there remains a paucity of high-level evidence to direct treatment decision making. Healthcare providers treating patients with malignant bowel obstruction should work to establish consensus guidelines, where feasible, to support medical providers in ensuring compassionate care during this often terminal event for this unique patient group.

Phyllodes Tumors: A Scoping Review of the Literature.

PURPOSE: Phyllodes tumors are rare tumors of the breast, with most literature being retrospective with limited guidelines on the management of these patients. Scoping review was performed to highlight themes and gaps in the available literature. METHODS: A scoping review of the literature was performed as per PRISMA-ScR guidelines with titles, abstracts, and full texts reviewed in duplicate. Data were abstracted and summarized in categories of diagnostics, surgical management, adjuvant therapies, treatment of recurrence, and surveillance. Quality assessment was performed for each paper. RESULTS: The search identified 4498 references, 434 full-text papers were reviewed, and 183 papers were included. Ultrasound, magnetic resonance imaging, and core needle biopsy are valuable preoperative diagnostics tools. Pathology reporting should include stromal overgrowth, stromal cellularity, nuclear atypia, mitotic rate, borders, and presence of heterologous elements. Ki67 may have a role in grading and prognosticating. Breast conservation is safe in all grades of phyllodes but may be associated with increased local recurrence in malignant phyllodes. Surgical margins should depend on grade. Axillary node positivity rate is very low, even with clinically enlarged lymph nodes. Adjuvant radiation is a useful tool to decrease local recurrence in malignant phyllodes tumors, tumors > 5 cm, age < 45 years, close margins, and breast conservation. There is no evidence supporting adjuvant chemotherapy. Recurrence can be managed with repeat wide excision; however, mastectomy is associated with lower re-recurrence. Surveillance protocols are variable in the literature. CONCLUSIONS: There is heterogeneity in the literature on phyllodes tumors. Consensus guidelines based on the literature will help provide evidence-based care.

Identification and Adjudication of Adverse Events Following Rectal Cancer Surgery: Observational Case Series in a Region of Ontario, Canada.

BACKGROUND: For patients undergoing rectal cancer surgery, we evaluated whether suboptimal preoperative surgeon evaluation of resection margins is a latent condition factor-a factor that is common, unrecognized, and may increase the risk of certain adverse events, including local tumour recurrence, positive surgical margin, nontherapeutic surgery, and in-hospital mortality. METHODS: In this observational case series of patients who underwent rectal cancer surgery during 2016 in Local Health Integrated Network 4 region of Ontario (population 1.4 million), chart review and a trigger tool were used to identify patients who experienced the adverse events. An expert panel adjudicated whether each event was preventable or nonpreventable and identified potential contributing factors to adverse events. RESULTS: Among 173 patients, 25 (14.5%) had an adverse event and 13 cases (7.5%) were adjudicated as preventable. Rate of surgeon awareness of preoperative margin status was low at 50% and similar among cases with and without an adverse event (p = 0.29). Suboptimal surgeon preoperative evaluation of surgical margins was adjudicated a contributing factor in all 11 preventable local recurrence, positive margin, and nontherapeutic surgery cases. Failure to rescue was judged a contributing factor in the two cases with preventable in-hospital mortality. CONCLUSIONS: Suboptimal surgeon preoperative evaluation of surgical margins in rectal cancer is likely a latent condition factor. Optimizing margin evaluation may be an efficient quality improvement target.

Challenges in virtual collection of patient-reported data: a prospective cohort study conducted in COVID-19 era.

Prior to the COVID-19 pandemic, patients attending ambulatory clinics at cancer centers in Ontario completed the Edmonton Symptom Assessment Scale (ESAS) at each visit. At our center, completion was via touchpad, with assistance from clinic volunteers. As of March 2020, clinic appointments were conducted virtually when possible and touch pads removed. We anticipated a negative impact on the collection of patient-reported outcomes (PROs) and the recognition of severe symptoms. METHODS: We performed a prospective cross-sectional cohort study to investigate remote ESAS completion by patients with appointments at a weekly surgical oncology clinic. Patients in the initial study cohort were asked to complete and return the ESAS virtually (V). Given low completion rates, the ensuing cohort was asked to complete a hard-copy (HC) ESAS. For the final cohort, we provided remote, personal mentorship by a member of the care team to support virtual electronic ESAS completion (virtual-mentored (VM) cohort). RESULTS: Between May and July 2020, a total of 174 patient encounters were included in the study. For the V cohort, 20/46 patients (44%) successfully completed and returned the electronic ESAS, compared to 49/50 (98%) for the HC cohort. For the VM cohort, the overall completion rate was 74% (58/78); however, 12 of these 58 patients did not independently complete a virtual ESAS. Virtual questionnaire completion was not predicted by age, sex, or tumor site, although patients who completed the ESAS were more likely to be in active management rather than surveillance (p = 0.04). Of all completed forms, 42% revealed a depression score of ≥2, and 27% an anxiety score of ≥4. CONCLUSIONS: We identified significant barriers to the virtual completion of ESAS forms, with a lack of predictive variables. The severe degree of psychological distress reported by ~50% of respondents demonstrates the need for ongoing regular collection/review of these data. Innovative solutions are required to overcome barriers to the virtual collection of PROs.

Medical Immunosuppression and Outcomes in Cutaneous Melanoma: A Population-Based Cohort Study.

BACKGROUND: Melanoma and the immune system are intimately related. However, the association of immunosuppressive medications (ISMs) with survival in melanoma is not well understood. The study evaluated this at a population level. METHODS: A cohort of patients with a diagnosis of invasive cutaneous melanoma (2007-2015) was identified from the Ontario Cancer Registry and linked to identify demographics, stage at diagnosis, prescription of immunosuppressive medications (both before and after diagnosis), and outcomes. The demographics of patients with and without prescriptions for ISM were compared. Patients eligible for Ontario's Drug Benefit Plan were included to ensure accurate prescription data. The primary outcome was overall survival. Cox Proportional Hazards Regression models identified factors associated with mortality, including use of ISM as a time-varying covariate. RESULTS: Of the 4954 patients with a diagnosis of cutaneous melanoma, 1601 had a prescription for ISM. The median age of the patients was 74 years. Overall, 58.4% of the patients were men (60.5% of those without ISM and 54% of those using ISM; p < 0.001). The use of oral immunosuppression was associated with an increased hazard of death (hazard ratio, 5.84; 95% confidence interval, 5.11-6.67; p < 0.0001) when control was used for age, disease stage at diagnosis, anatomic site, comorbidity, and treatment. Other factors associated with death were increasing age, male sex, increased disease stage, truncal location of primary melanoma, and inadequate treatment. In sensitivity analysis with steroid-only ISM use excluded, survival did not differ significantly (p = 0.355). CONCLUSIONS: The use of immunosuppressive steroids for melanoma is associated with worse overall survival. Use of steroids should be limited when possible.

Simultaneous resection of colorectal cancer with synchronous liver metastases; a practice survey.

BACKGROUND: We examined surgeon practice intentions and barriers to performing simultaneous resections for colorectal cancer with synchronous liver metastases. METHODS: We electronically surveyed North American surgeons who provide colorectal cancer care with a pilot-tested questionnaire. Four clinical scenarios of increasing complexity were presented. Perceived outcomes of and barriers to simultaneous resection were assessed on a 7-point Likert scale. We compared results between general and hepatobiliary surgeons. RESULTS: Responses (rate 20%, 234/1166) included 50 general and 134 hepatobiliary surgeons. High likelihood scores for support of simultaneous resection among general and hepatobiliary surgeons, respectively, included the following for: minor liver and low complexity colon, 83% and 98% (p < 0.001); minor liver and rectal resection, 57% and 73% (p = 0.042); complex liver and low complexity colon resection, 26% and 24% (p = 0.858); and, complex liver and rectal resection, 11% and 7.0% (p = 0.436). Among hepatobiliary surgeons, the most common barriers to simultaneous resections were patient comorbidities and lung metastases, whereas certain general surgeons additionally identified transfer of care. CONCLUSIONS: Surgeon support for simultaneous resection was high for cases with minor hepatectomy, and low for cases involving major hepatectomy. These results suggest that clinical trials should involve patients with limited disease to evaluate post-operative complications and cost.

Quality of preoperative pelvic computed tomography (CT) and magnetic resonance imaging (MRI) for rectal cancer in a region in Ontario: A retrospective population-based study.

BACKGROUND AND OBJECTIVES: Treatment decisions for rectal cancer rely on preoperative staging with CT and MRI scans. We assessed the quality of such scans in a region of Ontario. METHODS: We retrospectively collected data for patients undergoing rectal cancer surgery between July 2011 and December 2014. We measured three aspects of quality: use; comprehensiveness of reporting T-category, N-category, mesorectal fascia (MRF) status; and in non-radiated patients sensitivity and specificity of reports for relevant elements. RESULTS: A total of 559 patients underwent major rectal cancer surgery. Preoperative staging with CT and MRI was performed in 93% and 50% of patients. CT scan reports provided information on T-category, N-category, and MRF status in 41%, 92%, and 16% of cases. These same elements were reported on MRI in 88%, 93%, and 62% of cases. CT scan sensitivity and specificity was 80% and 80% for T-category, and 85% and 39% for N-category. MRI sensitivity and specificity was 75% and 81% for T-category, 79% and 37% for N-category, and 33% and 89% for MRF status. CONCLUSION: In this region of Ontario, pre-operative MRI was underutilized, CT reporting of MRF status was low, and when reported sensitivity and specificity of T- and N-category were similar for CT and MRI.

Modified frailty index predicts postoperative morbidity in adhesive small bowel obstruction: analyzing the National Inpatient Sample 2015-2019.

BACKGROUND: There are limited data identifying predictors of postoperative outcomes in adhesive small bowel obstruction (ASBO). This study used the National Inpatient Sample (NIS) to assess the efficacy of the modified frailty index (mFI) to predict postoperative morbidity among patients undergoing an operation for ASBO. METHODS: A retrospective analysis of the NIS between September 1, 2015, and December 31, 2019, was performed to identify adult patients who underwent nonelective operative intervention for ASBO. The mFI was used to stratify patients as either frail (mFI value ≥ 0.27) or robust (mFI value < 0.27). The primary outcomes were overall in-hospital postoperative morbidity and mortality. The secondary outcomes were system-specific morbidity, length of stay (LOS), total in-hospital healthcare cost, and discharge disposition. Univariable and multivariable regressions were used. RESULTS: Overall, 23251 robust patients and 6122 frail patients were included. Adjusted analyses demonstrated that frail patients had increased in-hospital mortality (adjusted odds ratio [aOR], 2.16; 95% CI, 1.80-2.60), postoperative morbidity (aOR, 1.63; 95% CI, 1.52-1.74), postoperative LOS (adjusted mean difference [aMD], 0.97 days; 95% CI, 0.73-1.21), and total in-hospital healthcare costs (aMD, $18,921; 95% CI, $14,608-$23,235) and were less likely to be discharged home (aOR, 0.59; 95% CI, 0.55-0.63). The findings were unchanged on subgroup analysis of patients undergoing open operation and those older than 65 years of age. CONCLUSION: The mFI may predict postoperative outcomes for ASBO. Stratifying patients based on frailty may assist clinicians and patients in making informed decisions, setting realistic expectations, and proactively planning postoperative disposition.

Developing a Data and Analytics Platform to Enable a Breast Cancer Learning Health System at a Regional Cancer Center.

PURPOSE: This study documents the creation of automated, longitudinal, and prospective data and analytics platform for breast cancer at a regional cancer center. This platform combines principles of data warehousing with natural language processing (NLP) to provide the integrated, timely, meaningful, high-quality, and actionable data required to establish a learning health system. METHODS: Data from six hospital information systems and one external data source were integrated on a nightly basis by automated extract/transform/load jobs. Free-text clinical documentation was processed using a commercial NLP engine. RESULTS: The platform contains 141 data elements of 7,019 patients with newly diagnosed breast cancer who received care at our regional cancer center from January 1, 2014, to June 3, 2022. Daily updating of the database takes an average of 56 minutes. Evaluation of the tuning of NLP jobs found overall high performance, with an F1 of 1.0 for 19 variables, with a further 16 variables with an F1 of > 0.95. CONCLUSION: This study describes how data warehousing combined with NLP can be used to create a prospective data and analytics platform to enable a learning health system. Although upfront time investment required to create the platform was considerable, now that it has been developed, daily data processing is completed automatically in less than an hour.

Extent of Surgical Resection in Inflammatory Bowel Disease Associated Colorectal Cancer: a Population-Based Study.

BACKGROUND: The extent of surgical resection in inflammatory bowel disease (IBD) patients who develop colorectal cancer (CRC) is not prescribed by guidelines. We aim to evaluate, at a population level, the association of extent of surgical resection with survival outcomes. METHODS: Using a validated Ontario registry of Crohn's disease (CD) and ulcerative colitis (UC) patients, we identified patients who underwent colorectal cancer resection between 2007 and 2015. Patient, tumor, and treatment factors, including type of surgical resection, were collected. Resections were grouped as segmental, total colectomy, and proctocolectomy. Multivariable cox proportional hazard regression was performed to identify factors associated with survival, including extent of surgical resection. RESULTS: Between 2007 and 2015, 84,694 patients had resections for CRC in the province of Ontario, 599 had ulcerative colitis (UC), and 366 had Crohn's disease (CD). Segmental resection was the most common operation performed and was more common in CD patients compared to UC (68% vs. 45.6%, p < 0.001). Five-year survival was 63.7% (95% CI 59.5-67.7) in UC patients and 57.5% (95% CI 51.9-62.7) in CD patients (p = 0.033). Multivariable analysis showed worse survival in patients undergoing total colectomy, compared to segmental resection [HR 1.70 (95% CI 1.31-2.21), p < 0.001]. There was no significant difference in survival between patients undergoing segmental resection and proctocolectomy [HR 0.99 (95% CI 0.78-1.27)]. This pattern was similar within the subtypes of IBD. CONCLUSION: In the setting of IBD-associated CRC, segmental resection and proctocolectomy are associated with similar survival outcomes in both UC and CD patients. Prospective study is essential to explore these findings.

Salvage surgery for locally recurrent anal cancer after intensity modulated radiation therapy with concurrent chemotherapy.

INTRODUCTION: Chemoradiation (CRT) with intensity modulated radiation treatment (IMRT) has become the standard for anal cancer. In patients who fail this treatment modality, salvage surgery with abdominal perineal resection can result in long term cancer control. We aimed to evaluate a single centre's experience of salvage surgery for local recurrence since the introduction of IMRT. MATERIALS AND METHODS: A retrospective chart review was performed of all patients who underwent definitive CRT for anal carcinoma at a single tertiary referral center since IMRT became standard in 2009. Patients with recurrent or persistent disease after treatment who underwent salvage surgery were included. Details of CRT, salvage surgery and surgical complications, patterns of recurrence after surgery, and survival data were collected and described. RESULTS: Between 2009-2018, 181 patients underwent definitive treatment using IMRT for anal carcinoma. Of 26 patients who had locoregional recurrent or persistent disease, 14 underwent salvage surgery. Nine had multi-visceral resection and 8 required autologous flap reconstruction. Twelve patients had resections with clear margins and 2 had microscopic positive margins. Twelve patients (86%) experienced post-operative complications, and eight (57%) had perineal wound complications. After salvage, four patients (29%) recurred locally. None of the 8 patients with rpT2 disease recurred. After salvage surgery, 5-year disease free survival was 68.4% and 5-year overall survival was 75%. CONCLUSION: Following IMRT based chemoradiation, salvage surgery has high rates of surgical complications; however disease free and overall survival results are excellent particularly for small recurrences.