James W. Fleshman M.D.

Smallwood, N. R., J. W. Fleshman, S. G. Leeds and J. S. Burdick (2016). “The use of endoluminal vacuum (e-vac) therapy in the management of upper gastrointestinal leaks and perforations.” Surg Endosc 30(6): 2473-2480.

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INTRODUCTION: Upper intestinal leaks and perforations are associated with high morbidity and mortality rates. Despite the growing experience using endoscopically placed stents, the treatment of these leaks and perforations remain a challenge. Endoluminal vacuum (E-Vac) therapy is a novel treatment that has been successfully used in Germany to treat upper gastrointestinal leaks and perforations. There currently are no reports on its use in the USA. METHODS: E-Vac therapy was used to treat 11 patients with upper gastrointestinal leaks and perforations from September 2013 to September 2014. Five patients with leaks following sleeve gastrectomy were excluded from this study. A total of six patients were treated with E-Vac therapy; these included: (n = 2) iatrogenic esophageal perforations, (n = 1) iatrogenic esophageal and gastric perforations, (n = 1) iatrogenic gastric perforation, (n = 1) gastric staple line leak following a surgical repair of a traumatic gastric perforation, and (n = 1) esophageal perforation due to an invasive fungal infection. Four patients had failed an initial surgical repair prior to starting E-Vac therapy. RESULTS: All six patients (100 %) had complete closure of their perforation or leak after an average of 35.8 days of E-Vac therapy requiring 7.2 different E-Vac changes. No deaths occurred in the 30 days following E-Vac therapy. One patient died following complete closure of his perforation and transfer to an acute care facility due to an unrelated complication. There were no complications directly related to the use of E-Vac therapy. Only one patient had any symptoms of dysphagia. This patient had severe dysphagia from an esophagogastric anastomotic stricture prior to her iatrogenic perforations. Following E-Vac therapy, her dysphagia had actually improved and she could now tolerate a soft diet. CONCLUSIONS: E-Vac therapy is a promising new method in the treatment of upper gastrointestinal leaks and perforations. Current successes need to be validated through future prospective controlled studies.

Leeds, S. G., J. S. Burdick and J. W. Fleshman (2016). “Endoluminal vacuum therapy for esophageal and upper intestinal anastomotic leaks.” JAMA Surg Apr 13 [Epub ahead of print].

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Anastomotic leak or intestinal perforation remains a major complication of surgery of the gastrointestinal tract and usually requires operative intervention. Complex management pathways for iatrogenic or failed anastomosis of the gastrointestinal tract, which are innovative and less invasive, need to be tested and implemented. The use of endoluminal vacuum (E-Vac) therapy accomplishes that goal. This technology uses negative pressure vacuum therapy through a natural orifice, such as the rectum or mouth, to control contamination through the intestinal opening and allows second-intention healing to perforations or leaks of the gastrointestinal tract. We are able to assemble the technology out of presently available wound care supplies used for traditional superficial wound closure modified for endoluminal placement. The technology entails delivery of a granulofoam endosponge secured to the tip of a well-tolerated, Silastic nasogastric tube that is placed at the site of gastrointestinal disruption after copious irrigation of the cavity. Negative pressure is applied to gain the desired effect similar to that observed for superficial wound management. This delivery is done endoscopically under general anesthesia, and the E-Vac materials are removed after the cavity has sealed (Figure). This article focuses on the use of E-Vac therapy for esophageal, gastric, and small intestine leaks or perforations.

Fleshman, J. (2016). “Improving Treatment of Uncomplicated Diverticulitis: The Old Appendicitis.” JAMA Surg. Feb 10. [Epub ahead of print]

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We continue to struggle with the perfect definition of the indication for an elective operation in the patient with diverticulitis. Simianu et al,1 in their review of the MarketScan Commercial Claims and Encounters Database, have attempted to determine the influences that drive early and late operation on patients with diverticulitis. The group from University of Washington, Swedish Hospital of Seattle, and Virginia Mason Clinic hypothesized that patients commonly undergo early (<3 episodes) elective resection for diverticulitis, especially when the patient is young and responsible for the cost of the operation, which is done laparoscopically, and the preceding episodes have been frequent over a short period. Simianu et al concluded that none of these factors influenced the decision to operate and at least 50% of patients had early operations. The database is a commercial insurance administrative database with all of the limitations of an administrative database. Since these are insured, non–immune-compromised patients with uncomplicated disease, there is an element of selection and bias. The clinical data that normally influence the timing of an operation are not available (computed tomography, white blood cell count, vital signs). In an interesting twist, the definition of an incident of diverticulitis included the use of antibiotics as an outpatient or an inpatient in combination with the code for diverticulitis or the prescription of ciprofloxacin and metronidazole, in combination, in a patient with a previous episode of diverticulitis. This should have increased the number of episodes beyond the 2 cases that have historically been used as an indication for an operation. It did not. There are, therefore, surgeons who persist in operating immediately for more than 1 episode of diverticulitis. This is reminiscent of the way we treated diverticulitis in past years. Why have we not seen an improvement in the consistency of patterns of elective operation? Can we have surgeons who hold fiercely onto autonomy? Why have surgeons in the southern part of the United States continued to operate early on patients with uncomplicated diverticulitis when the patients are not noticeably different from the patients elsewhere? If capitated patients are the least likely to have early operation of the insured patients from the multiple insurance plans represented in this database, it would seem that protocols and peer review are working to reduce unnecessary operations in these patients. There was also an association between open operations and early operation. Could this indicate that resistance to change is contributing to the problem? Older surgeons who have not adopted laparoscopic techniques may also be holding on to the outdated thoughts toward diverticulitis. Assuming that not all patients who underwent operation for early diverticulitis would have eventually have required operation, there is a possibility that we, as surgeons concerned with population health, could reduce the cost of care for these patients by prescribing bulk fiber and encouraging a healthy diet high in vegetables, all of which may help to avoid another episode of diverticulitis. There should never be a financial reason for operating on an early case of diverticulitis. Chronic malignant smoldering diverticulitis, that has caused stricturing and resulted in a difficult operation to remove the disease, usually develops after many more than 3 episodes of diverticulitis. It is my opinion that this should not be considered an excuse for early operation on uncomplicated diverticulitis. Patients usually have symptoms that point to the development of severe disease, such as chronic rather than intermittent pain, incomplete resolution of fever and leukocytosis, and partial obstructive symptoms with each episode. As Simianu et al mentioned in their article,1 time between episodes may be a significant influence on this progression as well. The concerned, informed, and ethical surgeon will adhere to the recommendations proposed by almost all of the national surgical societies to improve the care for patients with diverticulitis and avoid operation on early uncomplicated diverticulitis. This review did not indicate whether there is a difference between academic, major metropolitan community, and small community hospitals in their treatment of diverticulitis. The mobility of patients in search of health care should allow the appropriate care of uncomplicated diverticulitis as the public is better educated in the modern method of treating diverticulitis. As with all interesting studies, there are always more questions than answers at the end of the study. The authors acknowledge that the next step should be a focused prospective approach to answering the number of questions raised from their article. (Excerpt from text.)

Fleshman, J. (2016). “Current Status of Minimally Invasive Surgery for Rectal Cancer.” J Gastrointest Surg.

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Recent randomized controlled data have shown possible limitations to laparoscopic treatment of rectal cancer. The retrospective data, used as the basis for designing the trials, and which showed no problems with the technique, are discussed. The design of the randomized trials is discussed relative to the future meta-analysis of the recent data. The implications of the current findings on practice are discussed as surgeons try to adjust their practice to the new findings. The possible next steps for clinical and research innovations are put into perspective as new technology is considered to compensate for newly identified limitations in the laparoscopic treatment of rectal cancer.

Richardson, B., J. Preskitt, W. Lichliter, S. Peschka, S. Carmack, G. de Prisco and J. Fleshman (2016). “The effect of multidisciplinary teams for rectal cancer on delivery of care and patient outcome: has the use of multidisciplinary teams for rectal cancer affected the utilization of available resources, proportion of patients meeting the standard of care, and does this translate into changes in patient outcome?” American Journal of Surgery 211(1): 46-52.

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OBJECTIVES: To identify predictors of positive circumferential resection margin following rectal cancer resection in the United States. BACKGROUND: Positive circumferential resection margin is associated with a high rate of local recurrence and poor morbidity and mortality for rectal cancer patients. Prior study has shown poor compliance with national rectal cancer guidelines, but whether this finding is reflected in patient outcomes has yet to be shown. METHODS: Patients who underwent resection for stage I-III rectal cancer were identified from the 2010-2011 National Cancer Database. The primary outcome was a positive circumferential resection margin. The relationship between patient, hospital, tumor, and treatment-related characteristics was analyzed using bivariate and multivariate analysis. RESULTS: A positive circumferential resection margin was noted in 2859 (17.2%) of the 16,619 patients included. Facility location, clinical T and N stage, histologic type, tumor size, tumor grade, lymphovascular invasion, perineural invasion, type of operation, and operative approach were significant predictors of positive circumferential resection margin on multivariable analysis. Total proctectomy had nearly a 30% increased risk of positive margin compared with partial proctectomy (OR 1.293, 95%CI 1.185-1.411) and a laparoscopic approach had nearly 22% less risk of a positive circumferential resection margin compared with an open approach (OR 0.882, 95%CI 0.790-0.985). CONCLUSIONS: Despite advances in surgical technique and multimodality therapy, rates of positive circumferential resection margin remain high in the United States. Several tumor and treatment characteristics were identified as independent risk factors, and advances in rectal cancer care are necessary to approach the outcomes seen in other countries.