James W. Fleshman M.D.

Arnold, D. and J. W. Fleshman (2020). “Leadership in the Setting of the Operating Room Surgical Team.” Clin Colon Rectal Surg 33(4): 191-194.

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Leadership in the operating room requires the ability to adopt different styles under specific circumstances. Transformational leadership grows the team. The style used to guide the team can vary; coercive, visionary, affiliative, democratic, pacesetting, and coaching are all important styles in team leadership. The ability to adapt to different needs in the operating room by using the appropriate style is leadership.

Sankaranarayanan, G., C. A. Odlozil, K. O. Wells, S. G. Leeds, S. Chauhan, J. W. Fleshman, D. B. Jones and S. De (2020). “Training with cognitive load improves performance under similar conditions in a real surgical task.” Am J Surg Feb 10. [Epub ahead of print].

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BACKGROUND: Enhancing cognitive load while performing a bimanual surgical task affects performance. Whether repeated training under this condition could benefit performance in an operating room was tested using a virtual reality simulator with cognitive load applied through two-digit math multiplication questions. METHOD: 11 subjects were randomized to Control, VR and VR + CL groups. After a pre-test, VR and VR + CL groups repeated the peg transfer task 150 times over 15 sessions with cognitive load applied only for the last 100 trials. After training, all groups took a post-test and two weeks later the retention test with and without cognitive load and the transfer task on a pig intestine of 150 cm long under cognitive load. RESULTS AND CONCLUSION: Mixed ANOVA analysis showed significant differences between the control and VR and VR + CL groups (p = 0.013, p = 0.009) but no differences between the VR + CL and the VR groups (p = 1.0). GOALS bimanual dexterity score on transfer test show that VR + CL group outperformed both Control and VR groups (p = 0.016, p = 0.03). Training under cognitive load benefitted performance on an actual surgical task under similar conditions.

Fleshman, J. (2019). “Response to Comment on ‘Letter to the Editor for Z6051 (Revised 11/14/18).'” Ann Surg 270(2): e53-e54.

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Dr Martinez-Perez et al have identified some of the difficulties in performing randomized controlled trials in a surgical world that is constantly evolving. The Steering Committee of Z6051, meeting weekly throughout the early days of the trial and then monthly as time went on, have dealt with all of the questions that Dr Martinez-Perez raises in the letter to the editor. I wish to thank them for their comments and their attempt to bring to light the issues. In the Z6051 study comparing laparoscopic and open resection of rectal cancer we indeed chose to use the composite primary endpoint of the oncologic specimen findings to expedite the result of the technical issues with laparoscopic resection of rectal cancer. The focus on the specimen and the pathology evaluation is meant to serve as a means to determining the performance of good surgery and avoid waiting for 5 years to identify a detrimental effect on the long-term oncologic outcomes. The noninferiority analysis of the primary end point yielded a difference that prevented us from concluding noninferiority 3 years ago and raised the level of awareness of the potential hazards of treating low rectal cancer with laparoscopic techniques. This has impacted my practice and I have used hybrid laparoscopic operations to ensure good technique in the deep pelvis. The secondary endpoint of survival and disease-free survival (DFS), which is influenced by the combined treatment impact of the neoadjuvant therapy and the surgical therapy, has shown that our worries about harming patients may not need to be as significant as feared. The 2-year DFS, which has been reported as Kaplan–Meier curves including a large number of patients followed out 5 years, has shown no difference between the groups of patients. Low rectal cancer, especially those treated with Abdominoperineal resection (APR) in both groups, has shown a worse survival than those treated for higher rectal cancer with low anterior resection. I must agree that longer follow-up is needed in patients receiving neoadjuvant chemoradiation since recurrence has been seen at, or beyond, 10 years of follow-up. (Excerpt from text of the response to a letter regarding author’s article, Fleshman J, Branda ME, Sargent DJ, et al. Disease-free survival and local recurrence for laparoscopic resection compared with open resection of stage II to III rectal cancer: follow-up results of the ACOSOG Z6051 randomized controlled trial. Ann Surg. 2018 doi:10.1097/SLA0000000000003002.)

Scott, F. I., D. T. Rubin, S. Kugathasan, A. Bousvaros, C. O. Elson, R. D. Newberry, G. Y. Melmed, J. Pekow, J. W. Fleshman, B. M. Boyle, U. Mahadevan, L. M. Cannon, M. D. Long, R. K. Cross, C. Y. Ha, K. L. Lasch, A. M. Robinson, J. F. Rafferty, J. J. Lee, K. D. C. Dahl, A. Weaver, N. Shtraizent, G. Honig, A. Hurtado-Lorenzo and C. A. Heller (2019). “Challenges in IBD Research: Pragmatic Clinical Research.” Inflamm Bowel Dis 25(Supplement_2): S40-s47.

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Pragmatic clinical research is part of five focus areas of the Challenges in IBD research document, which also includes preclinical human IBD mechanisms, environmental triggers, novel technologies, and precision medicine. The Challenges in IBD research document provides a comprehensive overview of current gaps in inflammatory bowel diseases (IBD) research and delivers actionable approaches to address them. It is the result of multidisciplinary input from scientists, clinicians, patients, and funders, and represents a valuable resource for patient centric research prioritization. In particular, the pragmatic clinical research section is focused on highlighting gaps that need to be addressed in order to optimize and standardize IBD care. Identified gaps include: 1) understanding the incidence and prevalence of IBD; 2) evaluating medication positioning to increase therapeutic effectiveness; 3) understanding the utility of therapeutic drug monitoring (TDM); 4) studying pain management; and 5) understanding healthcare economics and resources utilization. To address these gaps, there is a need to emphasize the use of emerging data sources and real-world evidence to better understand epidemiologic and therapeutic trends in IBD, expanding on existing data to better understand how and where we should improve care. Proposed approaches include epidemiological studies in ethnically and geographically diverse cohorts to estimate incidence and prevalence of IBD and impact of diversity on treatment patterns and outcomes. The implementation of new clinical trial design and methodologies will be essential to evaluate optimal medication positioning, appropriate use of TDM in adults and children, and multidisciplinary approaches to IBD pain management and its impact on healthcare resources.

Wells, K. and J. Fleshman (2019). “Screening Colonoscopy Should Be Available to All.” JAMA Surg Apr 17. [Epub ahead of print].

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In a retrospective review of 16,000 patients in a systemwide experience of screening colonoscopy, Sarvepalli et al determined that the association of endoscopist specialty (surgeon or gastroenterologist) with adenoma detection rate was insignificant. This counters previously reported lower quality for colonoscopies and increased risk of missed adenomas and interval cancers by surgeons and confirms that colonoscopic quality indicators are adequately met by both gastroenterologists and nongastroenterologists. Sarvepalli et al do report differences between specialties not owing to random features of the endoscopists and other confounders, specifically, a decrement in the proximal sessile serrated adenoma (SSA) detection rate of 2.3% by surgeons vs 5.6% by gastroenterologists. The clinical significance of a 3.3% difference in the proximal SSA detection rate is questionable. Proximal SSAs arise via CpG island methylator phenotype pathway, with higher rates of methylation and carcinogenesis occurring in an age-dependent pattern. In a pathology series of 2416 SSAs, SSA-associated carcinoma was diagnosed at a mean age of 76 years vs 67 years among those with carcinoma arising in conventional adenomas. The SSAs do not progress as often or as quickly as conventional adenomas, accounting for their presence in the elderly cohort. In longitudinal computed tomographic colonographic assessment, 22% of SSAs progress vs 41% of conventional adenomas at an annual volumetric growth rate of 12.7% vs 36.4% in conventional adenomas (P = .03). The difference in median age between patients with SSA and SSA-associated carcinoma is 15 years vs a 5-year difference from tubular adenoma to conventional carcinoma, suggesting a 3-fold longer rate of progression to malignancy in SSA. Therefore, a second screening colonoscopy in 10 years would likely detect an early cancer or larger SSA. An SSA-harboring carcinoma represented only 1% of all specimens, which, if applied to the Sarvepalli et al study’s difference of 3.3%, translates into a miss rate of 3 SSA-associated carcinomas per 10 000 colonoscopies. In view of a slower progression of SSA to cancer in most cases, allowing a slightly higher miss rate in surveillance colonoscopy performed by nongastroenterologists might be acceptable. Eventual polypectomy, as less aggressive SSA lesions become larger, would be akin to the management of anal intraepithelial neoplasia III, where frequent observation of an affected mucosal field to remove visible lesions preserves the organ and effectively prevents progression to cancer. This study validates the surgeon in providing a high-quality screening and, more importantly, broadens the limited pool of clinicians to address low national screening rates. The question becomes whether well-trained nonspecialty clinicians with an acceptable adenoma detection rate could also provide screening. (Excerpt from text, p. e1; no abstract available.)