The SAGES Fundamental Use of Surgical Energy program (FUSE): history, development, and purpose.

BACKGROUND: Adverse events due to energy device use in surgical operating rooms are a daily occurrence. These occur at a rate of approximately 1-2 per 1000 operations. Hundreds of operating room fires occur each year in the United States, some causing severe injury and even mortality. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) therefore created the first comprehensive educational curriculum on the safe use of surgical energy devices, called Fundamental Use of Surgical Energy (FUSE). This paper describes the history, development, and purpose of this important training program for all members of the operating room team. METHODS: The databases of SAGES and the FUSE committee as well as personal photographs and documents of members of the FUSE task force were used to establish a brief history of the FUSE program from its inception to its current status. RESULTS: The authors were able to detail all aspects of the history, development, and national as well as global implementation of the third SAGES Fundamentals Program FUSE. CONCLUSIONS: The written documentation of the making of FUSE is an important contribution to the history and mission of SAGES and allows the reader to understand the idea, concept, realization, and implementation of the only free online educational tool for physicians on energy devices available today. FUSE is the culmination of the SAGES efforts to recognize gaps in patient safety and develop state-of-the-art educational programs to address those gaps. It is the goal of the FUSE task force to ensure that general FUSE implementation becomes multinational, involving as many countries as possible.

Criteria and benchmarks for laparoscopic cholecystectomy in a free-standing ambulatory center.

BACKGROUND AND OBJECTIVES: Keys to economic survival in an era of decreasing reimbursement include controlling costs and avoiding complications. In an effort to reduce costs, laparoscopic cholecystectomy has been performed with same-day discharge from a hospital setting. The free-standing ambulatory surgery center offers even greater cost savings if safety can be assured. Facility charges, surgical technique and instrument selection influence the costs of the procedure. METHODS: A database was accumulated prospectively on the first 100 laparoscopic cholecystectomies performed in a free-standing ambulatory surgery center to assess costs, logistical constraints, and safety. RESULTS: Laparoscopic cholecystectomies were accomplished in 99 of 100 patients. One patient was suspected of having cancer during laparoscopy and was transferred to a nearby hospital for open cholecystectomy. There were no other postoperative hospitalizations for complications. The fixed facility charge for the procedure was $2,990, and the total costs for all routinely disposable items (gowns, gloves, instruments, and adhesive bandages was $98. The mean OR time was 29 minutes (standard deviation 13.7). CONCLUSIONS: The free-standing ambulatory surgery center is an appropriate facility for an experienced operating team to perform laparoscopic cholecystectomy in selected patients. The surgeon's selection of appropriate energy sources and instruments is essential to complete the operation in a most cost-effective manner.

The "floppy diaphragm" sign with laparoscopic-associated pneumothorax.

Pneumothoraces in association with laparoscopy are uncommon and potentially disastrous complications that may also occur without adverse sequelae. The "floppy diaphragm sign" is a readily discernible and useful sign of a laparoscopic-induced pneumothorax. Tube thoracostomy is generally not indicated in stable patients as the pneumothorax typically resolves quickly upon desufflation of the pneumoperitoneum.

Selection criteria for laparoscopic cholecystectomy in an ambulatory care setting.

BACKGROUND: The ambulatory care center offers patient convenience and reduced costs after uneventful laparoscopic cholecystectomy. METHODS: A prospectively accumulated database of 1,750 cholecystectomies performed by one surgeon in a hospital setting was analyzed to test criteria for ambulatory cholecystectomy. Proposed criteria included age less than 65, absence of upper abdominal operations, and elective operations in healthy patients at low risk for common bile duct stones. RESULTS: Of 1,750 cholecystectomies, only 605 patients met all criteria for outpatient care. Discharge (from the in-hospital setting) was accomplished within 24 h of operation in 92% (first 3 years) and 98% (last 4 years) of selected cases. Only one patient (0.2%, 1/605) was converted to an open procedure; another was readmitted 30 h postoperatively with hemorrhage from the liver bed. CONCLUSIONS: Laparoscopic cholecystectomy can be performed safely in an ambulatory care setting, given careful selection and education of patients and documented experience of the surgical team.

Litigious consequences of open and laparoscopic biliary surgical mishaps.

Three hundred six injuries or complications coincident to 296 laparoscopic cholecystectomies were analyzed for the nature and extent of injuries and litigious outcomes that followed. The data were drawn from 31 member companies of the Physician Insurers Association of America, a trade association that initiated the study. The outcomes were compared to 261 contemporaneous open cholecystectomy claims. Biliary tract injuries were the most common, accounting for almost two thirds of all injuries. The spectrum of cases, originally selected for indemnity potential, reflected relative incidences in the medical literature. Laparoscopic injuries were significantly more severe, more likely to result in indemnity, and more apt to involve higher mean +/- standard deviation dollar values (160 dollars +/- 154 x 10(3)) to surviving claimants than injuries resulting from open procedures (106 dollars +/- 122 x 10(3), P = 0.01). Injury recognition at the time of the original procedure had no discernible mitigating effect because 80% of recognized injuries required an additional operative procedure. Risk-aversive behavior should include paying particular attention to placement of the first port, more liberal use of the Hasson technique, placement of all other ports under direct vision, elimination of intraoperative anatomic uncertainty, programmed inspection of the abdomen before withdrawing the laparoscope, and acquiring sufficient knowledge of electrosurgical principles to ensure the safe use of this potentially dangerous modality.

Laparoscopic electrosurgical complications and their prevention.

Insulation failures, direct coupling, and capacitive coupling around active electrodes may cause serious burns and tissue damage to patients undergoing laparoscopic procedures. A coordinated team effort between perioperative nurses and surgeons can prevent life-threatening complications from laparoscopic electrosurgical procedures. Knowledge of the biophysics of electrosurgery, the mechanisms of electrosurgery complications, and prevention of patient injuries will empower surgical team members to provide quality outcomes for patients undergoing laparoscopic procedures.

Steam sterilization of laparoscopic instruments.

Because of the intricate internal parts of laparoscopic instruments, questions have been raised about the efficacy of cleaning and sterilization techniques. To assess these risks, hamburger meat was inoculated with high concentrations of vegetative pathogens and packed into laparoscopic cannulas. All openings of the cannulas were sealed during steam sterilization cycles ranging from 3 to 10 min in different experiments; cultures were obtained after cooling. Experiments were then performed using heat-resistant spore forms. Our studies showed that both the standard 10-min cycle and the 3-min "flash" were uniformly successful in killing all pathogenic microorganisms. A 7-min steam sterilization was necessary to kill spores within sealed cannulas. We conclude that a standard 10-min cycle within the steam autoclave provides complete sterilization of laparoscopic instruments; the 3-min "flash" sterilization is appropriate and safe for instruments that have been inadvertently contaminated or dropped during a surgical procedure.

Common bile duct evaluation in the era of laparoscopic cholecystectomy. 1050 cases later.

OBJECTIVE: The authors documented the evolution of common bile duct (CBD) evaluation after the development of laparoscopic cholecystectomy (LC) and CBD exploration. Emphasis was placed on stratification of CBD stone risk so that subgroups could be selected appropriately for no further studies, preoperative endoscopic retrograde cholangiogram (ERC), or intraoperative intervention. METHODS: Data were accumulated by the authors on presentation, findings, and outcomes of 1050 patients who underwent cholecystectomies. Risk stratification was based on the history, ultrasound findings, biochemical derangements, and operative findings. RESULTS: Fifty-seven per cent of patients met criteria to be "no/low" risk for CBD stones (CBD diameter < 5 mm, normal liver enzymes, and no history of acute cholecystitis, jaundice, or pancreatitis); in these patients, cholangiograms were not obtained, and there was no clinical evidence of CBD stones observed in follow-up at 45 months (sensitivity = 100%). As techniques developed for laparoscopic CBD exploration, there was a decreased incidence of open cholecystectomy (p < 0.05) and preoperative ERC (p < 0.05). The rate of operative cholangiogram increased from 13% to 23% during the series (p < 0.01). There were no CBD injuries or late strictures. The only bile leak occurred from a peripheral segmental duct in the gallbladder bed and was resolved with a laparotomy and suture. There were no transfusions. Three retained stones were documented in patients who had false-normal operative cholangiograms. CONCLUSIONS: Criteria were defined that delineate a "no/low" risk group of LC patients for whom operative cholangiograms were not indicated for excluding CBD stones. The routine use of operative cholangiography as a means of preventing CBD injury was not substantiated by this study. The indications for preoperative ERC should continue to decrease as laparoscopic techniques evolve.

Unrecognized hazards of surgical electrodes passed through metal suction-irrigation devices.

Surgical electrodes, passed through metal suction-irrigation devices, pose significant risks for unrecognized visceral burns through capacitively coupled current using monopolar electrosurgery. Plastic cannulas (and reducers) should be avoided with the metal suction-irrigation electrode; an all-metal trocar cannula confers limited safety. With surgeon education and advances in engineering, the potential for unrecognized visceral injury with capacitive coupling can be eliminated.

Laparoscopic electrosurgery: complications and prevention.

Even though monopolar electrosurgery has been utilized laparoscopically for over two decades, post procedural complications, including bowel burns, remain significant. Initially employed by gynecologists, electrosurgical cutting and coagulation is rapidly becoming popular with general surgeons and urologists. Electrosurgery in a closed environment presents a special set of problems and in order to prevent complications surgeons need to familiarize themselves with the basic science of electrosurgery and the potential laparoscopic complications. This chapter presents an overview of the physics of electrosurgery with special attention to laparoscopic use. Also discussed are two technologies, a shielding-monitoring system for monopolar electrodes and bipolar electrodes, which minimize and/or eliminate potential laparoscopic complications associated with the use of electrosurgery.

Capacitive coupled stray currents during laparoscopic and endoscopic electrosurgical procedures.

Capacitively coupled currents may not be appreciated during laparoscopic and endoscopic radiofrequency electrosurgery. Two specific problems are documented and quantified: coupling of current into metal trocar cannulas during laparoscopic surgery and coupling of current into a guide wire during endoscopic surgery. The examples can yield power levels in excess of 25 watts (laparoscopic) and 15 watts (endoscopic) on nearby metal conductors, which can in turn be dissipated into patient organs such as the bowel or the common bile duct. This capacitive coupling can be, in part, responsible for serious patient complications. Methods to minimize capacitive coupling, e.g., active electrode shielding, dispersive metal cannulas, sheathed guide wires, and bipolar active electrodes, are discussed for each example.

Education and engineering solutions for potential problems with laparoscopic monopolar electrosurgery.

The potential problems of monopolar electrosurgery relate to unrecognized energy transfer ("stray current") outside the view of the laparoscope. Mechanisms of stray current and unrecognized tissue injury include: (1) insulation breaks in electrodes; (2) capacitive coupling, or induced currents through the intact insulation of the active electrode to surrounding cannulas or other instruments; and (3) direct coupling (or unintended contact) between the active electrode and other metal instruments or cannulas within the abdomen. Capacitive coupling poses the greatest risk for injury when the outer conductor (trocar cannula or irrigation cannula) is electrically isolated from the abdominal wall by a plastic nonconductor. Capacitive coupling is increased by the coagulation mode (versus cut), open circuit (versus tissue contact with the electrode), 5-mm cannulas (versus 11 mm), and higher voltage generators. The safety of electrosurgery can be enhanced by surgical education regarding the biophysics of radio frequency electrical energy, technical choices in instruments using all-metal cannula systems, and engineering developments with a dynamically monitored system for insulation failure and capacitive coupling.

Multipractice analysis of laparoscopic cholecystectomy in 1,983 patients.

We analyzed the results of laparoscopic cholecystectomy in 1,983 patients from a variety of practice settings in order to evaluate a large, cross-sectional experience for this new procedure. Twenty general surgeons from 9 clinics in 4 states examined the records and outcome of their laparoscopic cholecystectomy patients through March 1991. In 88 patients (4.5%), the operation was converted to an open procedure, usually because of marked inflammation and unclear anatomy. A total of 644 cases were performed with laser dissection and 1,339 with cautery, and the results of these 2 methods were similar. There were 41 complications. Reoperation for repair was necessary in 18 patients, including 5 with common duct injuries, and, to date, the outcome has been good in each patient. Seventy-six patients (3.8%) have had recognized common duct stones; these were removed preoperatively by endoscopic sphincterotomy (ERS) in 20 patients, during cholecystectomy in 46 patients, and postoperatively by ERS in 4 patients. In six patients, common duct stones became apparent 1 to 4 months after cholecystectomy. We conclude that trained general surgeons can perform laparoscopic cholecystectomy safely with risks comparable to those for conventional open cholecystectomy.

A practical approach to laparoscopic cholecystectomy.

A prospective study of 500 consecutive cholecystectomies was initiated with the introduction of laparoscopic cholecystectomy. Laparoscopic cholecystectomy was attempted in 96% of patients presenting with primary gallbladder disease and was completed in 95%. There were no deaths or bile duct injuries. Two patients undergoing laparoscopic cholecystectomy were transfused for postoperative bleeding, and only one patient required reoperation for any reason. A prospective study showed reduced operating time (20 minutes) and patient charges ($546) using electrosurgical dissection compared with laser. Reusable trocars were used without any associated injury or morbidity. An effective strategy for selective cholangiography was developed based on patient history, liver enzymes, and common duct diameter. In conclusion, laparoscopic cholecystectomy appears to be a safe operation. The cost-effectiveness of laparoscopic cholecystectomy can be enhanced ($1,271) with no loss of patient benefit using the combination of electrosurgery, reusable trocars, and selective cholangiograms in low-risk patients.