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BACKGROUND: Professional medical associations (PMAs) have an essential role in advancing medical care and health. PMAs promote skills training, clinical standards, and other important educational activities. Most often, PMAs are not-for-profit entities that rely upon funding from industry to help cover the costs of these valuable activities. Equally important, innovation and progress in surgery require physician collaboration with industry throughout the product development process. SAGES has opined that, with appropriate Conflict of Interest (COI) disclosure and management processes, PMA educational activities can be both scientifically and ethically sound. METHODS: SAGES has developed and implemented comprehensive and stringent processes for managing potential COI within the organization, at the annual meeting, and in developing educational offerings. This document reviews the SAGES COI processes and results 2009-2021. RESULTS: Implementation of the SAGES COI disclosure and management processes reduced the reported perceived incidence of bias at the annual meeting from 4.4-6.2% (2008-2010) to 1.2-2.2% (2011-2013). Recent comparison of reported disclosures revealed a rise in number of speakers with financial relationships and an increase in reporting of disclosures in presentations without an associated increase in need for conflict resolution by the COI committee. Despite good overall adherence to COI policies, SAGES was recently cited for non-compliance with ACCME standards related to inclusion of faculty with ownership interest. This experience highlighted the potential for discordance in the interpretation of whether disclosures relate to specific CME content. SAGES COI processes have since been updated to reflect the more stringent 2020 ACCME Standards that exclude speakers and planners with ownership interest from any CME activity. CONCLUSIONS: The SAGES experience with disclosure and mitigation of financial relationships highlights the challenges of validating the accuracy of physician disclosures and establishing the relevance of financial relationships to the content of accredited educational activities. SAGES will continue to streamline its COI disclosure process with specific focus on aligning all financial disclosures among the various reporting platforms.

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BACKGROUND: Financial relationships with industry may bias educational content delivered by physicians. SAGES strives to mitigate potential bias, relying on physician self-reporting. Retrospective review of relationships is possible using the Open Payments Database (OPD), a public record of industry-reported payments to US physicians. We aimed to evaluate the effectiveness of the SAGES disclosure process by comparing faculty disclosures to SAGES, faculty disclosures within presentations, and OPD records among speakers at the 2018-2020 SAGES meetings. METHODS: We reviewed all presentations from the SAGES 2018-2020 Annual Meetings. For each invited presentation, all slide-disclosed relationships were recorded. For US physicians, we queried the OPD and recorded relationships ≥ $500 USD in the calendar year prior to presentation. We compared the slide-disclosed relationships with OPD-reported relationships and with those provided to SAGES during the faculty disclosure process. We surveyed a sample of the 2020 annual meeting speakers to analyze potential reasons for discordance. RESULTS: From 2018 to 2020, there were 1,355 invited presentations, of which 1,234 (91%) were available for review. Disclosure slides were present in 1,098 (89%), increasing from 86% in 2018 to 93% in 2020. The proportion of speakers with OPD-reported relationships ≥ $500 increased from 54% in 2018 to 66% in 2020. The total value of OPD relationships decreased from $5.9 million (2018) to $3.3 million (2020) with a concomitant decrease in the proportion with high discordance from 9% in 2018 to 5% in 2020. Among the 2020 speakers with high discordance, the most common explanations for discordance were being unaware of payment or payment outside the 12-month timeframe (55%). CONCLUSIONS: Discordance between financial disclosures reported to SAGES and OPD highlight the need for improvements in the faculty disclosure process. SAGES will continue to streamline this process by incorporating faculty review of their OPD disclosures to ensure all educational programs remain free of commercial bias.

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BACKGROUND: The TAVAC and Pediatric Committees of SAGES evaluated the current use of mini-laparoscopic instrumentation to better understand the role this category of devices plays in the delivery of minimally invasive surgery today. METHODS: The role of mini-laparoscopic instrumentation, defined as minimally invasive instruments of between 1 and 4 mm in diameter, was assessed by an exhaustive review of the peer reviewed literature on the subject between 1990 and 2021. The instruments, their use, and their perceived value were tabulated and described. RESULTS: Several reported studies propose a value to using mini-laparoscopic instrumentation over the use of larger instruments or as minimally invasive additions to commonly performed procedures. Additionally, specifically developed smaller-diameter instruments appear to be beneficial additions to our minimally invasive toolbox. CONCLUSIONS: The development of small instrumentation for the effective performance of minimally invasive surgery, while perhaps best suited to pediatric populations, proves useful as adjuncts to a wide variety of adult surgical procedures. Mini-laparoscopic instrumentation thus proves valuable in selected cases.

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BACKGROUND: Surgical revision for weight regain after Roux-en-Y gastric bypass (RYGB) has been tempered by the high complication rates associated with standard approaches. Endoluminal revision of stoma and pouch dilation should intuitively confer a better risk profile. However, questions of clinical safety, durability, and weight loss need to be answered. We report our multicenter intraoperative experience and postoperative follow-up to date using the Incisionless Operating Platform for this patient subset. METHODS: The patients who had regained significant weight >or=2 years after RYGB after losing >or=50% of excess body weight after RYGB were endoscopically screened for stomal and/or pouch dilation. Qualified patients underwent incisionless revision using the Incisionless Operating Platform to reduce the stoma and pouch size by placing anchors to create tissue plications. Data on the safety, intraoperative performance, postoperative weight loss, and anchor durability were recorded to date as a part of 2 years of postoperative follow-up. RESULTS: A total of 116 consecutive patients were prospectively studied. Anchors were successfully placed in 112 (97%) of 116 patients, with an average intraoperative stoma diameter and pouch length reduction of 50% and 44%, respectively. The operating room time averaged 87 minutes. No significant complications occurred. At 6 months after the procedure (n = 96), an average of 32% of weight regain that had occurred after RYGB had been lost. The percentage of excess weight loss averaged 18%. The 12-month esophagogastroduodenoscopy results confirmed the presence of the anchors and durable tissue folds. CONCLUSIONS: Incisionless revision of stoma and pouch dilation using the Incisionless Operating Platform can be performed safely. The data to date have demonstrated mild-to-moderate weight loss, and the early 12-month endoscopic images have confirmed anchor durability. Patients were actively followed up to document the long-term durability of this intervention in the entire patient subset.

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INTRODUCTION: NOTES has become a clinical reality. There remain, however, many challenges that need to be addressed in order to refine the technique. One of the most feared potential complications of transgastric surgery is a leak from the port of entry into the peritoneum. When withdrawing the endoscope into the gastric lumen it is difficult to make a secure closure due to the loss of pneumogastrium. We present a novel and safe technique for creating a gastrotomy developed in our animal laboratory and applied in all of our human NOTES cholecystectomies. METHODS: Using an aggressive grasping and needle-delivery device, full-thickness bites create an imbricated ridge of tissue that acts as a valve, allowing visualization while maintaining pneumogastrium when the endoscope is withdrawn from the peritoneum into the lumen. At closure, full-thickness serosa-to-serosa approximation is easily achieved due to excellent visualization. RESULTS: With this technique we have been able to accomplish consistent results in ten pig models. In our series of five patients who have undergone NOTES transgastric cholecystectomy, there have been no leaks to date using the same technique. Video footage presents this technique performed on humans. CONCLUSIONS: Creation of a gastric valve during transgastric surgery has proved to be a safe approach. This technique allows maintenance of insufflation and visualization during the procedure and provides a feasible and safe means of closure at the end of the procedure.

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BACKGROUND: The concept of intraperitoneal flexible endoscopy has created much interest and investigation. Both gastroenterologists with a surgical leaning and surgeons with advanced endoscopy interests are researching the feasibility of this new approach. Current flexible scopes and instruments are extremely limited for use in natural orifice transluminal endoscopic surgery (NOTES). We describe the development of an endoscopic system specifically designed for endoluminal and NOTES procedures and demonstrates benefits and efficacy in benchtop and cadaver models. TECHNIQUE: In conjunction with industry, an 18-mm 4-channel rigidizing access device was designed. Measurements of the strength (torsional and lifting) of standard endoscopes and the new scope were made. The new device and instruments are used in 8 cadavers to document its feasibility in a variety of specific tasks: endoluminal plication, upper abdomen and lower abdomen visualization, bowel manipulation, solid organ retraction, cholecystectomy, and enterotomy closure. RESULTS: Benchtop comparison between a standard scope and the new scope showed equal maneuverability but the newer scope had greater force delivery at the tip (0.042 vs 1.96 lb, P < .001) and greater instrument application force (0.09 vs 0.23 lb, P < .002). Introduction of the scope was possible in all cadavers but difficult in cadavers <60 kg. Intragastric manipulation was feasible and exiting the stomach was possible although it required a 2-cm gastrotomy. The scope system was maneuverable in both lower quadrants without difficulty. The upper abdomen was viewable, with variable success in steering the scope between left and right quadrants. The entire gastrointestinal tract was able to be visualized in most cadavers. The scope generated sufficient force to lift and manipulate intraabdominal structures. Cholecystectomy was successful in 5 of 5 attempts. CONCLUSION: A new flexible access endoscope with 4 large access channels showed utility in a cadaver model-satisfying some of the requirements for performance of NOTES procedures.

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BACKGROUND: Laparoscopic instruments are rigid and thus cannot provide the degrees of freedom (DOF) needed by a surgeon in certain situations. A new generation of laparoscopic instruments with the ability to articulate their end effectors is available. Although these instruments offer the flexibility needed to perform complex tasks in a constricted surgical site, their control may be hampered by their increased complexity. METHODS: This study compared the task performance between articulating and conventional laparoscopic instruments. Surgeons with extensive laparoscopic experience (8 experts) and staff with no surgical experience (8 novices) were recruited for the test. Both groups were required to perform three standardized tasks (peg transfer, left-to-right suturing, and up-and-down suturing) in a bench top model using conventional and articulating instruments. Performance was scored using a standardized 100-point scale based on movement speed and accuracy. After the initial trials with conventional and articulating instruments, each participant was given a short orientation on how to use the articulating instrument advantageously. The participant then was retested with the articulating instrument. RESULTS: As expected, the expert group scored significantly better than the novice group (p < 0.001). The combined data from both groups showed better performance with the conventional instruments than with the articulating instruments (p = 0.074). The experts maintained their proficient laparoscopic performance using conventional instruments in their first attempts with the articulating instruments (91 vs. 84), whereas the novices had greater difficulty with the articulating instruments than with the conventional instruments (46 vs. 59). After a short orientation, however, the novices outscored the expert group in terms of net improvement in performance with the articulating instrument (27 vs. 1% improvement). CONCLUSION: Experienced surgeons are readily able to transfer their skills from conventional to articulating laparoscopic instruments. To speed the learning process, the use of articulating instruments can be started at an early stage of surgical training.

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BACKGROUND: The excitement surrounding natural orifice transluminal endoscopic surgery (NOTES) remains tempered by concerns over safe access and closure of transvisceral enterotomies. Research in NOTES has commonly been described as using an oral transgastric access point. Transanal endoscopic microsurgery (TEM) is a minimally invasive technique for a full-thickness resection of rectal tumors and with suture closure of the resultant defect with highly specialized instruments. This technique has been used clinically in human beings for more than 2 decades. Entry into the peritoneal cavity during a resection of rectosigmoid lesions has been described, and safe closure can be obtained. OBJECTIVE: To assess the feasibility of transrectal NOTES procedures by using TEM instrumentation. DESIGN: Three porcine and 3 human cadaver models were studied by using standard TEM instrumentation and flexible endoscopes. NOTES peritoneal access, a peritoneoscopy, a liver biopsy, and colorectal resections were performed. RESULTS: True NOTES procedures facilitated with TEM instrumentation were successfully completed. LIMITATIONS: This was a preclinical study, and several challenges to bridging to human clinical use exist: TEM instruments are currently designed for intraluminal tasks low in the pelvis, with 5-mm to 10-mm port sizes; the cost of the TEM instruments and insufflation system; and the learning curve to perform TEM closure. CONCLUSIONS: Our preclinical study demonstrated the feasibility of several transrectal NOTES procedures, colorectal resection, and anastomosis when using TEM instrumentation. We, therefore, suggest TEM as a portal for NOTES.

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BACKGROUND: Chylothorax after complex abdominal and thoracic procedures remains a challenging complication with a mortality rate reaching 50% if untreated. Iatrogenic trauma accounts for almost 20% of all chyle leaks, and esophagectomy is the most common iatrogenic cause. Consequences of ongoing chyle leak include dehydration, malnutrition, and immunocompromise. METHODS: When nonoperative management techniques fail, prompt ligation of the thoracic duct at the diaphragmatic hiatus should be attempted. The authors present prone thoracoscopic thoracic duct ligation performed for two patients after laparoscopic transthoracic esophagectomy and revision paraesophageal hernia repair. RESULTS: The prone position for thoracoscopic thoracic duct ligation offers several benefits to the surgeon. Gravity retracts the lung anteriorly, exposing the diaphragmatic hiatus. Single-lumen endotracheal intubation combined with low-pressure carbon dioxide insufflation efficiently collapses the lung to create ample working space. For the two reported patients, only three trocars were necessary to complete suture ligation of the thoracic duct via the right chest. Both patients had complete resolution of their chylothorax and recovered uneventfully. Based on this experience, the authors currently advocate early thoracoscopic treatment for cost and morbidity savings. CONCLUSIONS: The authors believe prone thoracoscopic thoracic duct ligation offers significant advantages to the patient in preventing the dangerous consequences of chyle leak in a timely, minimally invasive fashion. Importantly, the prone technique with carbon dioxide insufflation makes the technical challenges of thoracic duct ligation more facile for the surgeon.

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PURPOSE: To investigate stimulatory effects of PDGF-AA, PDGF-AB, PDGF-BB, bFGF, IL-1beta, TGF-beta1 and TGF-beta2 on the proliferation and myofibroblast transformation of cultured human Tenon's capsule fibroblasts and to characterize expression of PDGF- and TGF-beta-receptors in these cells. METHODS: To determine cell proliferation, cell number of 2nd passage cultured human Tenon's capsule fibroblasts was measured before and after addition of growth factors using a computer-based cell counter system. Immunoblotting was used to detect and quantitate alpha-smooth-muscle actin (alpha-SMA) expression. Expression of PDGF- and TGF-beta-receptor mRNA was detected by RT-PCR, expression of the corresponding protein was demonstrated using Western blot. RESULTS: A significant increase in proliferation (p < or = 0.05) was detected after exogenous stimulation with PDGF-AA (10 ng/ml and 100 ng/ml), PDGF-AB (10 ng/ml and 100 ng/ml), PDGF-BB (10 ng/ml and 100 ng/ml), bFGF (100 ng/ml), IL-1beta (1 ng/ml and 10 ng/ml), TGF-beta1 (0.5 ng/ml) and TGF-beta2 (0.5 ng/ml). Both TGF-beta1 and TGF-beta2 stimulated expression of alpha-SMA in a dose dependent manner with peak activity at a concentration of 50 ng/ml (TGF-beta1) and 500 ng/ml (TGF-beta2). Protein and mRNA of PDGF-receptor type alpha and type beta and TGF-beta-receptors type I, II and III are expressed in cultured human Tenon's capsule fibroblasts. CONCLUSIONS: The present investigation strongly supports the hypothesis that PDGF-isoforms are major stimulators of proliferation of Tenon's capsule fibroblasts after glaucoma filtering surgery while TGF-beta-isoforms are essential for the transformation of Tenon's capsule fibroblasts into myofibroblasts.

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BACKGROUND: The Melkersson-Rosenthal syndrome complex is characterised by asymmetric orofacial oedema, facial palsy, furrowed tongue (lingua plicata) and additional neurological symptoms. PATIENT: A 21-year old man presented with a bilateral asymmetric oedema of the eyelids which increased during the follow-up period of 12 years. Intermittent swelling of the auditory channel occurred and resulted in hearing loss. Furthermore, the patient complained unspecific neurological symptoms as headache, tinnitus and subjective visual defects. The lid oedema did not only result in cosmetic problems but seriously restricted visual fields. RESULTS: Our patient showed the typical symptoms of the Melkersson-Rosenthal complex, lacking however facial palsy which is often caused by mechanical compression along the course of the facial nerve. The differential diagnosis of recurrent swelling of the lids was discussed on an interdisciplinary plane. The inflammatory activity could be reduced and the frequency of swelling episodes could be diminished by a treatment with hydroxychloroquine. The initially relapsing, then persistent swelling had led to severe restriction of the visual field and resulted in a severe social stigmatisation and psychic stress for the patient. The surgical resection of the granulomatous tissue was carried out under steroid treatment to prevent recurrence. Histochemical analysis showed inflammation of the lymphoid plasmacellular type with mucipolysaccharidoid deposition typical of Melkersson-Rosenthal syndrome. Blepharoplasty resulted in an improved cosmetic appearance. The patient remained symptom-free with an excellent functional result. CONCLUSIONS: After persistence and constancy of the findings of a granulomatous blepharitis, surgical correction is a good opportunity to minimise the subjective complaints and neurological symptoms.

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BACKGROUND: In Austria, financing health care -and even more so mental health care- is characterized by a mix of federal and provincial responsibilities, lack of uniformity in service provision and service providers, and diverse funding arrangements. The division between financing structures for health care and social care makes the situation even more complex. This state of affairs results in various, partly counterproductive and sometimes paradoxical financial incentives and disincentives for the providers, recipients and financiers of mental health services. In several provinces of Austria, recent reform plans in mental health care have focused strongly on establishing community-based and patient-oriented mental health care. One of the main challenges in implementing this new policy is the re-allocation of resources. AIMS OF THE STUDY: The authors hypothesize that the existing structure of mental health care financing, with its incentives and disincentives, constitutes an obstacle to patient-oriented community-based mental health care. Analyzing the characteristics of the overall mental health care financing system in one Austrian province, Lower Austria, will provide a better understanding of actor-relationships and inherent incentives and highlight implications for the process of deinstitutionalization. METHOD: The authors used an analytical framework based on the principal-agent theory, empirical evidence, and information on financial, organizational and legal structures to identify the characteristics of actor-relationships and the position of single actors within the system. RESULTS: The article shows how incentives are linked to existing constellations of actors involved in mental health care financing and identifies significant power relations. As a consequence, incentives and disincentives within the financing system result in hospital- centered and supply-oriented mental health care in Lower Austria. DISCUSSION: The current system of financing mental health care provides an obstacle to the provision of patient-oriented and community-based mental care. This is due to existing constellations and power relations among the actors where, most importantly, patients are the weakest party in the patient-payer-provider triangle. Balancing power relations will be a significant prerequisite for alternative financing systems. IMPLICATIONS FOR HEALTH POLICIES AND FURTHER RESEARCH: If a community and needs-based mental health care system is to be established in Austria, the financing structures have to be changed accordingly. Applying a principal-agent framework is useful for identifying key aspects in mental health care financing in relation to the provision of services. Further research is needed to help develop alternative financing mechanisms that support community-based and patient-oriented mental health care systems.

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