Shadduck Pp

Ethical considerations regarding the implementation of new technologies and techniques in surgery

Ethical considerations relevant to the implementation of new surgical technologies and techniques are explored and discussed in practical terms in this statement, including (1) How is the safety of a new technology or technique ensured?; (2) What are the timing and process by which a new technology or technique is implemented at a hospital?; (3) How are patients informed before undergoing a new technology or technique?; (4) How are surgeons trained and credentialed in a new technology or technique?; (5) How are the outcomes of a new technology or technique tracked and evaluated?; and (6) How are the responsibilities to individual patients and society at large balanced? The following discussion is presented with the intent to encourage thought and dialogue about ethical considerations relevant to the implementation of new technologies and new techniques in surgery.

Intragastric Balloon for Overweight Patients.

Background and Objectives: Current treatments for overweight adults include reduced-calorie diet, exercise, behavior modification, and selective use of medications. Many achieve suboptimal results with these measures and progress to obesity. Whether the intragastric balloon (IGB), a reversible device approved for treatment of obesity, is a safe and effective option in overweight adults is less well studied. We conducted a study to prospectively analyze the safety and effectiveness of IGB in overweight adults, to compare the results to a simultaneously studied cohort of obese patients, and to share procedural tips for safe IGB placement and removal. Methods: One hundred thirty-nine patients were evaluated in this prospective, nonrandomized study. Twenty-six overweight [body mass index (BMI), 26–30)] and 113 obese (BMI > 30) patients underwent outpatient, endoscopic IGB placement under intravenous sedation. The IGB was filled with a 550–900 mL (average, 640 mL) solution of saline, radiological contrast, and methylene blue, with an approximate final proportion of 65:2:1. The patients were followed up at 1–2 weeks and then monthly for 6 months. At 6 months, they underwent IGB removal via an esophageal overtube to optimize safety, and then they were observed for 6 more months. Results: IGB time was 190 ± 36 d in the overweight patients and 192 ± 43 d in the obese patients. Symptoms of IGB intolerance included nausea and pain, which were transiently present in 50–95% of patients for several days, and necessitated early IGB removal in 6% of patients. There were no procedure-related complications and no IGB-related esophagitis, erosion, perforation, or obstruction. The percentage of excess weight loss (EWL%) was 96 ± 54% in the overweight group and 41 ± 26% in the obese group (P < 0.001). Conclusion: In overweight adults failing standard treatments, IGB placement for 6 months had an acceptable safety profile and excellent weight loss.

Low-Friction Minilaparoscopy Outperforms Regular 5-mm and 3-mm Instruments for Precise Tasks.

Background and Objectives: Therapeutic laparoscopy was incorporated into surgical practice more than 25 y ago. Several modifications have since been developed to further minimize surgical trauma and improve results. Minilaparoscopy, performed with 2- to 3-mm instruments was introduced in the mid 1990s but failed to attain mainstream use, mostly because of the limitations of the early devices. Buoyed by a renewed interest, new generations of mini instruments are being developed with improved functionality and durability. This study is an objective evaluation of a new set of mini instruments with a novel low-friction design. Method: Twenty-two medical students and 22 surgical residents served as study participants. Three designs of laparoscopic instruments were evaluated: conventional 5 mm, traditional 3 mm, and low-friction 3 mm. The instruments were evaluated with a standard surgical simulator, emulating 4 exercises of various complexities, testing grasping, precise 2-handed movements, and suturing. The metric measured was time to task completion, with 5 replicates for every combination of instrument–exercise–participant. Results: For all 4 tasks, the instrument design that performed the best was the same in both the medical student and surgical resident groups. For the gross-grasping task, the 5-mm conventional instruments performed best, followed by the low-friction mini instruments. For the 3 more complex and precise tasks, the low-friction mini instruments outperformed both of the other instrument designs. Conclusion: In standard surgical simulator exercises, low-friction minilaparoscopic instruments outperformed both conventional 3- and 5-mm laparoscopic instruments for precise tasks.

A Comprehensive Process for Identifying and Managing Conflicts of Interest Reduced Perceived Bias at a Specialty Society Annual Meeting

Physician–device manufacturer relationships are critical to the development of better devices for better patient care, yet there are many examples where these relationships have been mismanaged for financial gain, resulting in loss of public trust.1,2 Lo and Fields, in an Institute of Medicine Report, noted that physician industry relationships and practices can put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public trust in medicine.3 However, they also noted that conflicts of interest need to be distinguished from the related concepts of undue influence and bias. While disclosure of conflicts of interest may be the first step in identifying potential bias, the real goal is to prevent information being presented, especially at accredited programs, that is unduly influenced by a relationship with a commercial interest. Most of the literature focuses on the connection between commercial funding of CME and perceptions of bias. Researchers appear to find no connection between indus-

Informed Consent and Surgical Innovation

The goal of the informed consent process is intended to lead either the patient or the research subject to make an informed (educated) and voluntary choice. That is to choose whether or not to have a particular clinical treatment/operation or whether or not to choose to participate in a research study that may or may not be of specific benefit to him or her. The goal of this chapter is to review the now well-defined informed consent process for both clinical treatment and research involving human subjects and then examine the process in the context of clinical surgical innovation.

Professionalism of surgery

There is an increasing interest in medical professionalism, both within the medical community and in the larger public domain. Several groups, including the American Medical Association and the Council of Medical Specialty Societies, have published formal declarations on professionalism. The American Board of Internal Medicine Foundation, the American College of Physicians–American Society of Internal Medicine, and the European Federation of Internal Medicine have jointly developed the ‘‘Charter of Medical Professionalism’’ (Table 1) [1]. The Charter, who’s preamble states ‘‘Professionalism is the basis of medicine’s contract with society,’’ has been endorsed by the Board of Regents of the American College of Surgeons (ACS) [2] and more than 130 organizations worldwide, and it has been translated into 12 languages [3]. The ACS, with its own Professionalism Task Force, has published its ‘‘Code of Professional Conduct’’ (Table 2) [4]. A year later the ACS Task Force no longer saw ‘‘The Code’’ as just desirable, but as the very core of the profession of surgery [5]. This topic has truly gained traction in the medical community, and it is appropriate and timely for SAGES to reflect upon this topic and to express its understanding of professionalism for our society’s members as well as the general public. First, the question of needing another statement on professionalism must be addressed. A statement from our society is valuable for at least two reasons. Like other societies who have valued professionalism, issuing a formal statement on the subject affirms its significance for our society’s members and declares that professional behavior from our members is expected. Second, even though statements on professional conduct have been previously published, they vary in content and emphasis, and little has been written about professionalism specific to surgery, with no statements to date representing a clear ‘‘final word’’ on the theme. This statement is an effort to contribute to the dialog on this important issue.