Informed consent: a shared decision-making process that creates a new professional obligation for care.

This statement on informed consent, developed by the SAGES Ethics Committee, has been reviewed and approved by the Board of Governors of SAGES. This statement is provided to offer guidance about the purpose and process of obtaining informed consent, and it is intended for practicing surgeons as well as patients seeking surgical intervention. It is an expression of well-established principles and extensive literature. Excluded from this document are discussions of informed consent for research and informed consent for introduction of new technology, as that has been addressed in previous publications (Strong in Surg Endosc 28:2272, 2014; Stefanidis in Surg Endosc 28:2257, 2014; as reported by Sillin (in: Stain (ed) The SAGES Manual Ethics of Surgical Innovation, Springer, Switzerland, 2016)).

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.

Portal vein thrombosis after laparoscopic cholecystectomy.

INTRODUCTION: Portal vein thrombosis (PVT) is a relatively uncommon complication after abdominal surgery. CASE REPORT: We report an even more unusual case of PVT 10 days after an uncomplicated laparoscopic cholecystectomy, believed to be only the fourth reported case in the literature of this rare complication. CONCLUSION: Albeit extremely rare, PVT should be included in the differential diagnosis for abdominal symptoms and/or elevated hepatic function tests after laparoscopic cholecystectomy.

Industry relationships between physicians and professional medical associations: corrupt or essential?

Congress and others have called into question the propriety of relationships between professional medical associations (PMAs) and industry. These relationships are critical to the continued development of new and better devices and procedures for patients. Better guidelines are needed to help guide these relationships. Overrestrictive regulatory oversight risks overconstraint of these relationships and hindrance to medical progress.

Face and construct validity of a computer-based virtual reality simulator for ERCP.

BACKGROUND: Currently, little evidence supports computer-based simulation for ERCP training. OBJECTIVE: To determine face and construct validity of a computer-based simulator for ERCP and assess its perceived utility as a training tool. DESIGN: Novice and expert endoscopists completed 2 simulated ERCP cases by using the GI Mentor II. SETTING: Virtual Education and Surgical Simulation Laboratory, Medical College of Georgia. MAIN OUTCOME MEASUREMENTS: Outcomes included times to complete the procedure, reach the papilla, and use fluoroscopy; attempts to cannulate the papilla, pancreatic duct, and common bile duct; and number of contrast injections and complications. Subjects assessed simulator graphics, procedural accuracy, difficulty, haptics, overall realism, and training potential. RESULTS: Only when performance data from cases A and B were combined did the GI Mentor II differentiate novices and experts based on times to complete the procedure, reach the papilla, and use fluoroscopy. Across skill levels, overall opinions were similar regarding graphics (moderately realistic), accuracy (similar to clinical ERCP), difficulty (similar to clinical ERCP), overall realism (moderately realistic), and haptics. Most participants (92%) claimed that the simulator has definite training potential or should be required for training. LIMITATIONS: Small sample size, single institution. CONCLUSIONS: The GI Mentor II demonstrated construct validity for ERCP based on select metrics. Most subjects thought that the simulated graphics, procedural accuracy, and overall realism exhibit face validity. Subjects deemed it a useful training tool. Study repetition involving more participants and cases may help confirm results and establish the simulator's ability to differentiate skill levels based on ERCP-specific metrics.

Mesh-free laparoscopic spigelian hernia repair.

Varied Spigelian hernia mesh repair techniques have been described, although evidence suggests laparoscopy results in less morbidity and shorter hospitalization compared with open procedures. Laparoscopic suture repair of Spigelian hernias is rarely reported. Two patients with small Spigelian hernias (< or =2 cm) were diagnosed and repaired laparoscopically using a transabdominal suture technique. Under laparoscopic guidance, a suture-passer was used to place two or three transfacial, interrupted 0 polypropylene sutures along the horizontal plane of the defect. Sutures were tied extracorporeally and closure was confirmed laparoscopically. These cases spurred a review of world literature (2001-2007) including clinical characteristics, operative techniques, and urgency of operations in Spigelian hernia patients. Data were compared using Fisher's exact test. One year postoperatively, the patients are without sequelae or recurrence. Literature review demonstrated most patients were females (P < 0.001), ranged in age from 60 to 80 years (P = 0.042), and presented with left-sided hernias (P = 0.026). Open mesh repair (182/392 cases; 47%) was the most common technique; however, increasingly articles describe laparoscopic mesh repair. Mesh-free laparoscopic suture repair is feasible and safe. This novel uncomplicated approach to small Spigelian hernias combines the benefits of laparoscopic localization, reduction, and closure without the morbidity and cost associated with foreign material.

Survey of student education in surgery.

BACKGROUND: Few data exist comparing medical student surgical education programs across the US and Canada. We conducted a 30-question, Web-based survey of 142 medical schools in the US and Canada about the administration of undergraduate surgical education programs at their institutions. STUDY DESIGN: From October 2005 to January 2006, 142 Association of American Medical Colleges (AAMC) medical schools in the US and Canada were asked to complete a 30-item, Web-based questionnaire. Descriptive statistics were compiled for all responses and data were analyzed using Student's t-test. RESULTS: One hundred two medical schools responded to the survey (90 of 125 US and 12 of 17 Canadian schools, overall response rate,=72%). The majority of surgical clerkships have between 16 and 30 students rotating at a time through 2 to 4 teaching sites. The most frequent overall clerkship duration was 8 weeks, divided most frequently between a 4- to 6-week general surgery rotation and a 4-week subspecialty rotation. There was no consensus about what services constitute general surgery rotations, although the most common subspecialty rotations were urology (68%) and orthopaedics (66%). American medical schools were more likely to use the National Board of Medical Examiners (NBME) subject examination for student assessment (90.9% US versus 50.0% Canadian, p < 0.05); Canadian medical schools were more likely to use an Objective Structured Clinical Examination (69.2% Canadian versus 37.7% US, p < 0.05) and other written examinations (69.2% Canadian versus 37.7% US, p < 0.05). CONCLUSIONS: There is wide variation in the structure and administration of medical student surgical education programs in the US and Canada. These findings underscore the need for a clerkship directors committee and a national dialog about a core student curriculum to ensure consistency in the quality of student education in surgery.

Initial experience with a novel endoscopic device allowing intragastric manipulation and plication.

BACKGROUND: Current developments in intraluminal and transluminal natural orifice surgery are limited by issues of access, tissue manipulation, and secure tissue approximation/closure. This report describes an initial laboratory experience with a novel tissue approximation and suturing device. The device is deployed via a previously described platform and is 6 mm in diameter. Desirable qualities of this tissue approximation/closure device include robust tissue grasping, minimal tissue trauma, fully visualized anchor placement via off-axis needle and anchor deployment, full reloadability without instrument withdrawal, single-operator operating capability, torque-stable manipulability, and operator-controlled tension setting of tissue anchor pairs. METHOD: The device was trialed in performing several maneuvers in porcine or canine models. The features of the system allowed bimanual tissue manipulation, full-thickness tissue approximation and plication, and secure closure of an ex vivo gastrotomy hole similar to that used during transluminal surgical interventions. CONCLUSIONS: This device appears to offer promise in achieving more complex endoluminal and potentially transluminal tasks, including secure suture closure of tissue defects and access holes. As such, devices of this type may prove useful in addressing some of the identified barriers to further development of natural orifice surgical intervention. Further investigation of the qualities and capabilities of this device in these settings is warranted.

Laparoscopic common bile duct exploration.

In recent years, laparoscopic common bile duct exploration has become the procedure of choice in the management of choledocholithiasis in several laparoscopic centers. The increasing interest for this laparoscopic approach is due to the development of instrumentation and technique, allowing the procedure to be performed safely, and it is also the result of the revised role of endoscopic retrograde cholangiopancreatography, which has been questioned because of its cost, risk of complications and effectiveness. Many surgeons, however, are still not familiar with this technique. In this article we discuss the technique and results of laparoscopic common bile duct exploration. Both the laparoscopic transcystic approach and choledochotomy are discussed, together with the results given in the literature. When one considers the costs, morbidity, mortality and the time required before the patient can return to work, it would appear that laparoscopic cholecystectomy with common bile duct exploration is more favorable than open surgery or laparoscopic cholecystectomy with preoperative or postoperative endoscopic sphincterotomy. However, the technique requires advanced laparoscopic skills, including suturing, knot tying, the use of a choledochoscope, guidewire, dilators and balloon stone extractor. Although laparoscopic common bile duct exploration appears to be the most cost-effective method to treat common bile duct stones, it should be emphasized that this procedure is very challenging, and it should be performed by well-trained laparoscopic surgeons with experience in biliary surgery.