The Effect of Product Safety Courses on the Adoption and Outcomes of LESS Surgery.

BACKGROUND AND OBJECTIVES: As technology in surgery evolves, the medical instrument industry is inevitability involved in promoting the use and appropriate (ie, effective and safe) application of its products. This study was undertaken to evaluate industry-supported product safety courses in laparoendoscopic single-site (LESS) surgery, by using the metrics of surgeons' adoption of the technique, safety of the procedure, and surgeons' perception of the surgery. METHODS: LESS surgery courses that involved didactic lectures, operative videos, operation observation, collaborative learning, and simulation, were attended by 226 surgeons. With Florida Hospital Tampa Institutional Review Board approval, the surgeons were queried before and immediately after the course, to assess their attitudes toward LESS surgery. Then, well after the course, the surgeons were contacted, repeatedly if necessary, to complete questionnaires. RESULTS: Before the course, 82% of the surgeons undertook more than 10 laparoscopic operations per month. Immediately after the course, 86% were confident that they were prepared to perform LESS surgery. Months after the course, 77% of the respondents had adopted LESS surgery, primarily cholecystectomy; 59% had added 1 or more trocars in 0-20% of their procedures; and 73% held the opinion that operating room observation was the most helpful learning experience. Complications with LESS surgery were noted 12% of the time. Advantages of the technique were better cosmesis (58%) and patient satisfaction (38%). Disadvantages included risk of complications (37%) and higher technical demand (25%). Seventy-eight percent viewed LESS surgery as an advancement in surgical technique. CONCLUSION: In multifaceted product safety courses, operating room observation is thought to provide the most helpful instruction for those wanting to undertake LESS surgery. The procedure has been safely adopted by surgeons who frequently perform laparoscopies. The tradeoff is in performing a more difficult technique to obtain better cosmesis for the patient. We must continue to conduct critical evaluations of product safety courses for the introduction of new technology in surgery.

Patients' perceptions of laparoendoscopic single-site surgery: the cosmetic effect.

BACKGROUND: Laparoendoscopic single-site (LESS) surgery can be performed without apparent scarring, while maintaining the salutary benefits of conventional laparoscopic surgery. The purpose of this study was to compare patients' preoperative and postoperative perceptions of LESS surgery. METHODS: Before and after undergoing LESS surgery, 120 patients were given questionnaires; their responses were assimilated and analyzed. RESULTS: Of 120 patients, 62% were female (age, 52 ± 16.6 y), and 54% had prior abdominal surgery. Preoperatively, women and older patients reported heightened appearance dissatisfaction. Preoperatively, most patients would not accept more risk, pain, surgery/recovery times, and/or costs than associated with standard laparoscopy. Postoperatively, patients reported increased satisfaction in their overall and abdominal region appearance. Satisfaction was noted by 92%; satisfaction was related significantly to scar appearance and cosmesis. CONCLUSIONS: Preoperatively, patients were most concerned with safety; postoperatively, patients' concerns shifted to cosmetic outcome. LESS surgery provides an opportunity for improved patient satisfaction.

A single institution's experience and journey with over 1000 laparoscopic fundoplications for gastroesophageal reflux disease.

There have been great advances in laparoscopic surgery for gastroesophageal reflux disease (GERD), including laparoendoscopic single-site (LESS) surgery. This study details our experience with over 1000 patients undergoing fundoplication for GERD and the journey therein. A total of 1078 patients have been prospectively followed after fundoplication. Patients scored the frequency/severity of symptoms using a Likert scale (0 = never/not bothersome to 10 = always/very bothersome). We compared the outcomes of the first and last 100 patients. Median data are reported. Of 1078 patients, 943 underwent conventional laparoscopic fundoplication and 135, most recently, underwent LESS fundoplication. Before fundoplication, patients noted frequent/severe symptoms (e.g., heartburn: frequency = 8, severity = 8). Fundoplication ameliorated frequency/severity of symptoms (e.g., heartburn: frequency = 2, severity = 0; less than preoperatively, P < 0.05). Relative to our first 100 patients, patients after LESS surgery had similar symptom control (e.g., heartburn: frequency = eight to two vs eight to zero, severity = eight to one vs six to one) but had shorter hospital stays (2 vs 1 day, P < 0.05) and had no apparent scars. Laparoscopic fundoplication provides durable and efficacious treatment for GERD; long-term symptom resolution and patient satisfaction support its continued application. The advent of LESS surgery advances surgeons' abilities to provide safe and salutary care while promoting cosmesis.

Targeting early deaths following pancreaticoduodenectomy to improve survival.

INTRODUCTION: There is increasing focus on disease-specific outcomes. This study was undertaken to analyze early mortality after pancreaticoduodenectomy as part of a strategy to improve long-term outcome. METHODS: One thousand thirty-one patients who underwent pancreaticoduodenectomy from 1992 to 2010 were studied. Median data are reported. RESULTS: Fifty-eight (5.6%) patients died within 90 days after pancreaticoduodenectomy. All patients had at least one significant comorbidity, commonly cardiorespiratory in nature (76%). Sixty percent of patients had depressed serum albumin levels, and 43% were jaundiced. The American Society of Anesthesiologists class was: 17% class II, 72% class III, and 10% class IV. Seventy-four percent had malignant disease. Twenty-two percent of patients underwent a major vascular resection at the time of pancreaticoduodenectomy. Causes of death were vascular/bleeding related (26%), cardiorespiratory causes (17%), multiorgan failure (12%), leak/perforation (10%), cancer progression (9%), infection (7%), or indeterminate (19%). CONCLUSIONS: Death within 90 days after pancreaticoduodenectomy is uncommon, occurs in relatively older deconditioned patients, and is generally not causally related to underlying malignancy. Early death is generally associated with vascular or bleeding complications. Strategies to minimize early death should focus on careful patient selection and prompt recognition and management of herald bleeding or vascular thrombosis, as it can often result in perioperative death following pancreaticoduodenectomy.

Gastroesophageal reflux disease.

Millions of Americans are affected by gastroesophageal reflux disease (GERD) in many different ways. The magnitude of the problem of GERD was brought to light by the ambulatory pH test, the introduction of minimally invasive surgery, and the advent of the many medications that are effective in acid suppression. Patients with GERD suffer from various consequences associated with the disease. However, interventions beyond medical therapy, such as laparoscopic fundoplication, provide satisfactory outcomes and definitive relief of acid reflux.