James W. Fleshman M.D.

Fleshman, J., M. E. Branda, D. J. Sargent, A. M. Boller, V. V. George, M. A. Abbas, W. R. Peters, Jr., D. C. Maun, G. J. Chang, A. Herline, A. Fichera, M. G. Mutch, S. D. Wexner, M. H. Whiteford, J. Marks, E. Birnbaum, D. A. Margolin, D. W. Larson, P. W. Marcello, M. C. Posner, T. E. Read, J. R. T. Monson, S. M. Wren, P. W. T. Pisters and H. Nelson (2018). “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 Aug 3. [Epub ahead of print].

Full text of this article.

OBJECTIVE: To determine the disease-free survival (DFS) and recurrence after the treatment of patients with rectal cancer with open (OPEN) or laparoscopic (LAP) resection. BACKGROUND: This randomized clinical trial (ACOSOG [Alliance] Z6051), performed between 2008 and 2013, compared LAP and OPEN resection of stage II/III rectal cancer, within 12 cm of the anal verge (T1-3, N0-2, M0) in patients who received neoadjuvant chemoradiotherapy. The rectum and mesorectum were resected using open instruments for rectal dissection (included hybrid hand-assisted laparoscopic) or with laparoscopic instruments under pneumoperitoneum. The 2-year DFS and recurrence were secondary endpoints of Z6051. METHODS: The DFS and recurrence were not powered, and are being assessed for superiority. Recurrence was determined at 3, 6, 9, 12, and every 6 months thereafter, using carcinoembryonic antigen, physical examination, computed tomography, and colonoscopy. In all, 486 patients were randomized to LAP (243) or OPEN (243), with 462 eligible for analysis (LAP = 240 and OPEN = 222). Median follow-up is 47.9 months. RESULTS: The 2-year DFS was LAP 79.5% (95% confidence interval [CI] 74.4-84.9) and OPEN 83.2% (95% CI 78.3-88.3). Local and regional recurrence was 4.6% LAP and 4.5% OPEN. Distant recurrence was 14.6% LAP and 16.7% OPEN.Disease-free survival was impacted by unsuccessful resection (hazard ratio [HR] 1.87, 95% CI 1.21-2.91): composite of incomplete specimen (HR 1.65, 95% CI 0.85-3.18); positive circumferential resection margins (HR 2.31, 95% CI 1.40-3.79); positive distal margin (HR 2.53, 95% CI 1.30-3.77). CONCLUSION: Laparoscopic assisted resection of rectal cancer was not found to be significantly different to OPEN resection of rectal cancer based on the outcomes of DFS and recurrence.

Sankaranarayanan, G., L. Wooley, D. Hogg, D. Dorozhkin, J. Olasky, S. Chauhan, J. W. Fleshman, S. De, D. Scott and D. B. Jones (2018). “Immersive virtual reality-based training improves response in a simulated operating room fire scenario.” Surg Endosc 32(8): 3439-3449.

Full text of this article.

BACKGROUND: SAGES FUSE curriculum provides didactic knowledge on OR fire prevention. The objective of this study is to evaluate the impact of an immersive virtual reality (VR)-based OR fire training simulation system in combination with FUSE didactics. METHODS: The study compared a control with a simulation group. After a pre-test questionnaire that assessed the baseline knowledge, both groups were given didactic material that consists of a 10-min presentation and reading materials about precautions and stopping an OR fire from the FUSE manual. The simulation group practiced on the OR fire simulation for one session that consisted of five trials within a week from the pre-test. One week later, both groups were reassessed using a questionnaire. A week after the post-test both groups also participated in a simulated OR fire scenario while their performance was videotaped for assessment. RESULTS: A total of 20 subjects (ten per group) participated in this IRB approved study. Median test scores for the control group increased from 5.5 to 9.00 (p = 0.011) and for the simulation group it increased from 5.0 to 8.5 (p = 0.005). Both groups started at the same baseline (pre-test, p = 0.529) and reached similar level in cognitive knowledge (post-test, p = 0.853). However, when tested in the mock OR fire scenario, 70% of the simulation group subjects were able to perform the correct sequence of steps in extinguishing the simulated fire whereas only 20% subjects in the control group were able to do so (p = 0.003). The simulation group was better than control group in correctly identifying the oxidizer (p = 0.03) and ignition source (p = 0.014). CONCLUSIONS: Interactive VR-based hands-on training was found to be a relatively inexpensive and effective mode for teaching OR fire prevention and management scenarios.

Sankaranarayanan, G., L. Wooley, D. Hogg, D. Dorozhkin, J. Olasky, S. Chauhan, J. W. Fleshman, S. De, D. Scott and D. B. Jones (2018). “Immersive virtual reality-based training improves response in a simulated operating room fire scenario.” Surg Endosc. Jan 25. [Epub ahead of print].

Full text of this article.

BACKGROUND: SAGES FUSE curriculum provides didactic knowledge on OR fire prevention. The objective of this study is to evaluate the impact of an immersive virtual reality (VR)-based OR fire training simulation system in combination with FUSE didactics. METHODS: The study compared a control with a simulation group. After a pre-test questionnaire that assessed the baseline knowledge, both groups were given didactic material that consists of a 10-min presentation and reading materials about precautions and stopping an OR fire from the FUSE manual. The simulation group practiced on the OR fire simulation for one session that consisted of five trials within a week from the pre-test. One week later, both groups were reassessed using a questionnaire. A week after the post-test both groups also participated in a simulated OR fire scenario while their performance was videotaped for assessment. RESULTS: A total of 20 subjects (ten per group) participated in this IRB approved study. Median test scores for the control group increased from 5.5 to 9.00 (p = 0.011) and for the simulation group it increased from 5.0 to 8.5 (p = 0.005). Both groups started at the same baseline (pre-test, p = 0.529) and reached similar level in cognitive knowledge (post-test, p = 0.853). However, when tested in the mock OR fire scenario, 70% of the simulation group subjects were able to perform the correct sequence of steps in extinguishing the simulated fire whereas only 20% subjects in the control group were able to do so (p = 0.003). The simulation group was better than control group in correctly identifying the oxidizer (p = 0.03) and ignition source (p = 0.014). CONCLUSIONS: Interactive VR-based hands-on training was found to be a relatively inexpensive and effective mode for teaching OR fire prevention and management scenarios.

Leeds, S. G., L. Wooley, G. Sankaranarayanan, Y. Daoud, J. Fleshman and S. Chauhan (2017). “Learning Curve Associated With an Automated Laparoscopic Suturing Device Compared With Laparoscopic Suturing.” Surg Innov 24(2): 109-114.

Full text of this article.

BACKGROUND: Laparoscopic suturing has proved to be a challenging skill to master which may prevent surgical procedures from being started, or completed, in a minimally invasive fashion. The aim of this study is to compare the learning curves between traditional laparoscopic techniques with a novel suturing device. METHODS: In this prospective single blinded nonrandomized controlled crossover study, we recruited 19 general surgery residents ranging from beginner (PGY1-2, n = 12) to advanced beginner (PGY3-5, n = 7). They were assigned to perform a knot tying and suturing task using either Endo360 or traditional laparoscopic technique (TLT) with needle holders before crossing over to the other method. The proficiency standards were developed by collecting the data for task completion time (TCT in seconds), dots on target (DoT in numbers), and total deviation (D in mm) on 5 expert attending surgeons (mean +/- 2SD). The test subjects were “proficient” when they reached these standards 2 consecutive times. RESULTS: Number of attempts to complete the task was collected for Endo360 and TLT. A significant difference was observed between mean number of attempts to reach proficiency for Endo360 versus TLT ( P = .0027) in both groups combined, but this was not statistically significant in the advanced beginner group. TCT was examined for both methods and demonstrated significantly less time to complete the task for Endo360 versus TLT ( P < .0001). There were significantly less DoT for Endo360 as compared with TLT ( P < .0001), which was also associated with significantly less D ( P < .0001) indicating lower accuracy with Endo360. However, no significant difference was observed between the groups for increasing number of trials for both DoT and D. CONCLUSIONS: This novel suturing device showed a shorter learning curve with regard to number of attempts to complete a task for the beginner group in our study, but matched the learning curve in the advanced beginner group. With regard to time to complete the task, the device was faster in both groups.

Haskins, I. N., J. W. Fleshman, R. L. Amdur and S. Agarwal (2016). “The impact of bowel preparation on the severity of anastomotic leak in colon cancer patients.” J Surg Oncol 114(7): 810-813.

Full text of this article.

BACKGROUND AND OBJECTIVES: The routine use of preoperative bowel preparation (BP) is heavily debated in the colorectal surgery literature. To date, no study has investigated the effect preoperative BP has on patients with an established anastomotic leak. We therefore seek to compare the severity of patient morbidity and mortality in patients with a known anastomotic leak based on type of preoperative BP using the Targeted Colectomy American College of Surgeons National Surgery Quality Improvement Program (ACS-NSQIP). METHODS: All elective colon cancer operations performed with primary anastomosis were identified within the targeted colectomy database from 2012 to 2013. Patients who experienced a postoperative anastomotic leak were identified and stratified based on preoperative BP. Variables that had an association with mechanical BP at P < 0.10 were included in a multivariate logistic regression model to determine if BP was independently associated with postoperative morbidity and mortality. RESULTS: A total of 6,297 patients underwent elective colon resection with primary anastomosis for colon cancer. Two hundred and nineteen (3.5%) patients experienced an anastomotic leak. Thirty-day wound morbidity and mortality was not worse in patients who underwent preoperative BP. CONCLUSIONS: BP is not associated with worse patients outcomes in those patients with an established anastomotic leak following elective colon research with primary anastomosis.