Registry‐based randomized clinical trials in surgery: Working with ACS‐NSQIP and the AHPBA to conduct pragmatic trials

Randomized controlled trials (RCTs) represent the gold standard for evidence in clinical medicine because of their ability to account for the effects of unmeasured confounders and selection bias by indication. However, their complexity and immense costs limit their application, and thus the availability of high-quality data to guide clinical care. Registry-based RCTs are a type of pragmatic trial that leverages existing registries as a platform for data collection, providing a low-cost alternative for randomized studies. Herein, we describe the tenets of registry RCTs and the development of the first AHPBA/ACS-NSQIP-based registry trial

Cefoxitin versus piperacillin–tazobactam as surgical antibiotic prophylaxis in patients undergoing pancreatoduodenectomy: protocol for a randomised controlled trial

Introduction Although antibiotic prophylaxis is established in reducing postoperative surgical site infections (SSIs), the optimal antibiotic for prophylaxis in pancreatoduodenectomy (PD) remains unclear. The study objective is to evaluate if administration of piperacillin–tazobactam as antibiotic prophylaxis results in decreased 30-day SSI rate compared with cefoxitin in patients undergoing elective PD.Methods and analysis This study will be a multi-institution, double-arm, non-blinded randomised controlled superiority trial. Adults ≥18 years consented to undergo PD for all indications who present to institutions participating in the National Surgical Quality Improvement Program Hepato-Pancreato-Biliary (NSQIP HPB) Collaborative will be included. Data collection will use the NSQIP HPB Collaborative Surgical Clinical Reviewers. Patients will be randomised to either 1–2 g intravenous cefoxitin or 3.375–4.5 g intravenous piperacillin–tazobactam within 60 min of surgical incision. The primary outcome will be 30-day postoperative SSI rate following PD. Secondary outcomes will include 30-day postoperative mortality; specific postoperative complication rate; and unplanned reoperation, length of stay, and hospital readmission. A subset of patients will have bacterial isolates and sensitivities of intraoperative bile cultures and SSIs. Postoperative SSIs and secondary outcomes will be analysed using logistic regression models with the primary predictor as the randomised treatment group. Additional adjustment will be made for preoperative biliary stent presence. Additionally, bacterial cultures and isolates will be summarised by presence of bacterial species and antibiotic sensitivities.Ethics and dissemination This study is approved by the Institutional Review Board at Memorial Sloan Kettering Cancer Center. This trial will evaluate the effect of piperacillin–tazobactam compared with cefoxitin as antibiotic prophylaxis on the hazard of postoperative SSIs. The results will be disseminated regardless of the effect of the intervention on study outcomes. The manuscript describing the effect of the intervention will be submitted to a peer-reviewed journal when data collection and analyses are complete.Trial registration number NCT03269994

Association of Preoperative Smoking with Complications Following Major Gastrointestinal Surgery

Background: Understanding modifiable surgical risk factors is essential for preoperative optimization. We evaluated the association between smoking and complications following major gastrointestinal surgery. Methods: Patients who underwent elective colorectal, pancreatic, gastric, or hepatic procedures were identified in the 2017 ACS NSQIP dataset. The primary outcome was 30-day death or serious morbidity (DSM). Secondary outcomes included pulmonary complications, wound complications, and readmission. Multivariable logistic regression was used to evaluate the association between smoking and these outcomes. Results: A total of 46,921 patients were identified, of whom 7,671 (16.3%) were smokers. Smoking was associated with DSM (23.2% vs. 20.4%, OR 1.15 [1.08-1.23]), wound complications (13.0% vs. 10.4%, OR 1.24 [1.14-1.34]), pulmonary complications (4.9% vs 2.9%, OR 1.93 [1.70-2.20]), and unplanned readmission (12.6% vs. 11%, OR 1.14 [95% CI 1.06-1.23]). Conclusions: Smoking is associated with complications following major gastrointestinal surgery. Patients who smoke should be counseled prior to surgery regarding risks

Experiences With Unionization Among General Surgery Resident Physicians, Faculty, and Staff

Importance: Labor unions are a mechanism for employee advocacy, but their role in surgery resident wellness is poorly characterized. Objective: To understand experiences with unionization among general surgery residents and residency program faculty and staff. Design, setting, and participants: This exploratory qualitative study included data from the Surgical Education Culture Optimization Through Targeted Interventions Based on National Comparative Data (SECOND) trial. In the exploratory phase of the SECOND trial (from March 6, 2019, to March 12, 2020), semistructured interviews about wellness were conducted with residents, faculty (attending physicians), and staff (program administrators) at 15 general surgery residency programs. Unionization was identified as an emergent theme in the interviews. Data analysis was performed from March 2019 to May 2023. Main outcomes and measures: The main outcome was resident and faculty experience with resident labor unions. In the qualitative analysis, lexical searches of interview transcripts identified content regarding resident labor unions. A codebook was developed inductively. Transcripts were coded by dyads, using a constant comparative approach, with differences reconciled by consensus. Results: A total of 22 interview transcripts were identified with relevant content. Of these, 19 were individual interviews conducted with residents (n = 10), faculty (n = 4), administrative staff (n = 1), a program director (n = 1), a department chair (n = 1), and designated institutional officials (n = 2), and 3 were from resident focus groups. Residents from all postgraduate year levels, including professional development (ie, research) years, were represented. Interviewees discussed resident unions at 2 programs (1 recently unionized and 1 with a decades-long history). Interviewees described the lack of voice and the lack of agency as drivers of unionization ("Residents…are trying to take control of their well-being"). Increased salary stipends and/or housing stipends were the most concretely identified union benefits. Unanticipated consequences of unionization were described by both residents and faculty, including (1) irrelevance of union-negotiated benefits to surgical residents, (2) paradoxical losses of surgery department-provided benefits, and (3) framing of resident-faculty relationships as adversarial. Union executives were noted to be nonphysician administrators whose participation in discussions about clinical education progression may increase the time and effort to remediate a resident and/or reduce educators' will to meaningfully intervene. Active surgical resident participation within the union allows for an understanding of surgical trainees' unique needs and reduced conflict. Conclusions and relevance: In this qualitative study, unionization was a mechanism for resident voice and agency; the desire to unionize likely highlighted the lack of other such mechanisms in the training environment. However, these findings suggest that unionization may have had unintended consequences on benefits, flexibility, and teaching. Effective advocacy, whether within or outside the context of a union, was facilitated by participation from surgical residents. Future research should expand on this exploratory study by including a greater number of institutions and investigating the evolution of themes over time

Management of colorectal cancer during the COVID‐19 pandemic: Recommendations from a statewide multidisciplinary cancer collaborative

COVID-19 has resulted in significant disruptions in cancer care. The Illinois Cancer Collaborative (ILCC), a statewide multidisciplinary cancer collaborative, has developed expert recommendations for triage and management of colorectal cancer when disruptions occur in usual care. Such recommendations would be applicable to future outbreaks of COVID-19 or other large-scale disruptions in cancer care

A National Quality Improvement Study Identifying and Addressing Cancer Screening Deficits Due To the COVID-19 Pandemic

Background: Cancer-related deaths over the next decade are expected to increase due to cancer screening deficits associated with the coronavirus disease 2019 (COVID-19) pandemic. Although national deficits have been quantified, a structured response to identifying and addressing local deficits has not been widely available. The objectives of this report are to share preliminary data on monthly screening deficits in breast, colorectal, lung, and cervical cancers across diverse settings and to provide online materials from a national quality improvement (QI) study to help other institutions to address local screening deficits. Methods: This prospective, national QI study on Return-to-Screening enrolled 748 accredited cancer programs in the United States from April through June 2021. Local prepandemic and pandemic monthly screening test volumes (MTVs) were used to calculate the relative percent change in MTV to describe the monthly screening gap. Results: The majority of facilities reported monthly screening deficits (colorectal cancer, 80.6% [n = 104/129]; cervical cancer, 69.0% [n = 20/29]; breast cancer, 55.3% [n = 241/436]; lung cancer, 44.6% [n = 98/220]). Overall, the median relative percent change in MTV ranged from -17.7% for colorectal cancer (interquartile range [IQR], -33.6% to -2.8%), -6.8% for cervical cancer (IQR, -29.4% to 1.7%), -1.6% for breast cancer (IQR, -9.6% to 7.0%), and 1.2% for lung cancer (IQR, -16.9% to 19.0%). Geographic differences were not observed. There were statistically significant differences in the percent change in MTV between institution types for colorectal cancer screening (P = .02). Conclusion: Cancer screening is still in need of urgent attention, and the screening resources made available online may help facilities to close critical gaps and address screenings missed in 2020. Lay summary: Question: How can the effects of the coronavirus disease 2019 pandemic on cancer screening be mitigated? Findings: When national resources were provided, including methods to calculate local screening deficits, 748 cancer programs promptly enrolled in a national Return-to-Screening study, and the majority identified local screening deficits, most notably in colorectal cancer. Using these results, 814 quality improvement projects were initiated with the potential to add 70,000 screening tests in 2021. Meaning: Cancer screening is still in need of urgent attention, and the online resources that we provide may help to close critical screening deficits

Unbundling Bundles: Evaluating the Association of Individual Colorectal Surgical Site Infection Reduction Bundle Elements on Infection Rates in a Statewide Collaborative

BACKGROUND: Surgical site infection reduction bundles are effective but can be complex and resource intensive. Understanding which bundle elements are associated with reduced surgical site infections may guide concise bundle implementation. OBJECTIVE: To evaluate the association of individual surgical site infection reduction bundle elements with infection rates. DESIGN: Post-hoc analysis of a prospective cohort study SETTING: Illinois Surgical Quality Improvement Collaborative hospitals PATIENTS: Elective colorectal resections at participating hospitals from 2016–2017 INTERVENTIONS: 16-element colorectal surgical site infection reduction bundle MAIN OUTCOME MEASURES: Surgical site infection rates were compared among patients by adherence with each bundle element using Chi-squared tests and multivariable logistic regression. Principal component analysis identified composites of correlated bundle elements. Coincidence analysis identified combinations of bundle elements or principal component composites associated with the absence of surgical site infection. RESULTS: Among 2,722 patients, 192 (7.1%) developed a surgical site infection. Infections were less likely when oral antibiotics (OR 0.63 [95% CI 0.41–0.97]), wound protectors (OR 0.55 [95% CI 0.37–0.81]), and occlusive dressings (OR 0.71 [95% CI 0.51–1.00]) were used. Bundle elements were reduced into 5 principal component composites. Adherence with the combination of (1) oral antibiotics, (2) wound protector, or (3) redosing intravenous antibiotic prophylaxis plus chlorhexidine-alcohol intraoperative skin preparation were associated with the absence of infection (consistency=0.94, coverage=0.96). Four of the five principal component composites in various combinations were associated with the absence of surgical site infection, while the composite consisting of occlusive dressing placement, postoperative dressing removal, and daily postoperative chlorhexidine incisional cleansing had no association with the outcome. LIMITATIONS: The inclusion of hospitals engaged in quality improvement initiatives may limit the generalizability of these data. CONCLUSION: Bundle elements had varying association with infection reduction. Implementation of colorectal surgical site infection reduction bundles should focus on the specific elements associated with low surgical site infections. See Video Abstract at http://links.lww.com/DCR/Bxxx

Preoperative Nutritional Optimization of the Oncology Patient: A Scoping Review

BACKGROUND: Malnutrition is common among patients with cancer and is a known risk factor for poor postoperative outcomes; however, preoperative nutritional optimization guidelines are lacking in this high-risk population. The objective of this study was to review the evidence regarding preoperative nutritional optimization of patients undergoing general surgical operations for the treatment of cancer. METHODS: A literature search was performed across the Ovid (MEDLINE), Cochrane Library (Wiley), Embase (Elsevier), CINAHL (EBSCOhost), and Web of Science (Clarivate) databases. Eligible studies included randomized clinical trials, observational studies, reviews, and meta-analyses published between 2010 and 2020. Included studies evaluated clinical outcomes after preoperative nutritional interventions among adult patients undergoing surgery for gastrointestinal cancer. Data extraction was performed using a template developed and tested by the study team. RESULTS: A total of 5,505 publications were identified, of which 69 studies were included for data synthesis after screening and full text review. These studies evaluated preoperative nutritional counseling, protein-calorie supplementation, immunonutrition supplementation, and probiotic or symbiotic supplementation. CONCLUSIONS: Preoperative nutritional counseling and immunonutrition supplementation should be considered for patients undergoing surgical treatment of gastrointestinal malignancy. For malnourished patients, protein-calorie supplementation should be considered, and for patients undergoing colorectal cancer surgery, probiotics or symbiotic supplementation should be considered

Barriers and Facilitators to Implementing Patient-Reported Outcome Monitoring in Gastrointestinal Surgery

Introduction: More than 30% of patients experience complications after major gastrointestinal (GI) surgery, many of which occur after discharge when patients and families must assume responsibility for monitoring. Patient-reported outcomes (PROs) have been proposed as a tool for remote monitoring to identify deviations in recovery, and recognize and manage complications earlier. This study's objective was to characterize barriers and facilitators to the use of PROs as a patient monitoring tool following GI surgery. Methods: We conducted semistructured interviews with GI surgery patients and clinicians (surgeons, nurses, and advanced practitioners). Patients and clinicians were asked to describe their experience using a PRO monitoring system in three surgical oncology clinics. Using a phenomenological approach, research team dyads independently coded the transcripts using an inductively developed codebook and the constant comparative approach with differences reconciled by consensus. Results: Ten patients and five clinicians participated in the interviews. We identified four overarching themes related to functionality, workflow, meaningfulness, and actionability. Functionality refers to barriers faced by clinicians and patients in using the PRO technology. Workflow represents problematic integration of PROs into the clinical workflow and need for setting expectations with patients. Meaningfulness refers to lack of patient and clinician understanding of the impact of PROs on patient care. Finally, actionability reflects barriers to follow-up and practical use of PRO data. Conclusions: While use of PRO systems for postoperative patient monitoring have expanded, significant barriers persist for both patients and clinicians. Implementation enhancements are needed to optimize functionality, workflow, meaningfulness, and actionability