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.

Margin status impacts survival after pancreaticoduodenectomy but negative margins should not be pursued.

Negative margins are the goal with pancreaticoduodenectomy for pancreatic adenocarcinoma. Thereby, margins are assessed intraoperatively with frozen section analysis and negative margins are pursued. This study was undertaken to determine the impact of margin status with pancreaticoduodenectomy for pancreatic adenocarcinoma and the value of extending resections to achieve negative margins. The intraoperative frozen section analysis and final margins for 448 patients undergoing pancreaticoduodenectomy for pancreatic adenocarcinoma were assessed and their impact on survival was determined. Median data are presented. Two hundred ninety-eight (67%) patients had negative margins (R0), an additional 110 (25%) patients had microscopically positive and macroscopically negative margins (R1), and an additional 40 (9%) patients had initially positive microscopic margins, which became negative with further resection (R1 → R0). R0 resections were more likely to have smaller tumors, earlier T grade, earlier N grade, lower American Joint Committee on Cancer stage, and less frequent extrapancreatic extension (P ≤ 0.03 for each). Survival was better with R0 resections than R1 resections (20 vs 12 months, P < 0.001); extending resections to achieve negative margins (i.e., R1 → R0) did not improve survival beyond R1 resections (14 vs 12 months, P = 0.19). Survival after pancreaticoduodenectomy is disappointing. Patients with initial negative margins do best. Positive microscopic margins reflect more aggressive tumor-specific factors and lead to abbreviated survival even with extended resections to achieve negative margins (i.e., R1 → R0). With an initial positive margin, pursuing negative margins does not improve survival and, thereby, negative margins should not be "chased."

Transduodenal ampullectomy for ampullary adenomas: a safe and effective procedure with long-term salutary outcomes.

With widespread use of endoscopy, ampullary adenomas are more frequently identified, many of which are not amenable to endoscopic resection. Pancreatoduodenctomy is curative for these lesions but carries high morbidity. The purpose of this study was to determine the safety and efficacy of transduodenal ampullectomy for these lesions. Data were collected on 32 patients who underwent transduodenal ampullectomy from 2002 to 2010. The median age of patients was 64 years. Adenomas were found because of abdominal pain in 34 per cent, jaundice in 22 per cent, and incidentally on endoscopic screening in 16 per cent and on computed tomography scan of the abdomen in 9 per cent. All patients had a preoperative diagnosis of premalignant disease; 6 per cent required intraoperative conversion to pancreaticoduodenectomy after frozen section evaluation documented carcinoma. Of ampullectomies, 97 per cent had clear margins. Follow-up was 28 months. Four (13%) patients developed recurrent disease at 4 years, 2 years, 1.5 years, and 4 months; all had clear margins at ampullectomy and underwent subsequent pancreaticoduodenectomy with invasive malignancy in a single patient. After preoperative biopsy documenting premalignant disease, malignancy at ampullectomy is unusual. Recurrence is uncommon but occurs even with clear margins necessitating diligent follow-up; even with diligent follow-up, recurrence can be malignant.

Laparoendoscopic single site (LESS) vs. conventional laparoscopic fundoplication for GERD: is there a difference?

BACKGROUND: This report details our experience with laparoendoscopic single site (LESS) fundoplication for GERD and provides a comparison to earlier contiguous patients undergoing conventional laparoscopic fundoplication. METHODS: With institutional review board approval, symptoms before and after LESS fundoplications and conventional laparoscopic fundoplications were scored by patients. Outcomes after 130 consecutive LESS fundoplications were compared to 130 contiguous consecutive outcomes after conventional laparoscopic fundoplications. RESULTS: Patients undergoing conventional laparoscopic vs. LESS fundoplication were very similar. There were no conversions to "open" operations and no notable complications with LESS fundoplication. Symptom reduction was broad and dramatic for patients undergoing LESS or conventional laparoscopic fundoplication; 96 % of patients who underwent LESS fundoplication scored their incision as ≥8 (1 = revolting to 10 = beautiful). CONCLUSIONS: Relative to conventional laparoscopy, LESS surgery provides excellent resolution of symptoms without an apparent scar. In comparison to conventional laparoscopy, LESS fundoplication is as safe with similar symptom improvement and superior cosmesis.

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.

Readmissions after pancreaticoduodenectomy: efforts need to focus on patient expectations and nonhospital medical care.

Readmissions after operations are a burden. This study was undertaken to determine factors predicting readmissions after pancreaticoduodenectomy. Since 1991, patients undergoing pancreaticoduodenectomy have been prospectively followed. Nineteen per cent of 913 patients were readmitted within 30 days after discharge from pancreaticoduodenectomy. The causes for readmissions were reviewed. Median data are presented. All patients had preoperative comorbidities; most common were cardiovascular (26%), gastrointestinal (23%), or endocrine (15%). Twenty-nine per cent had extended pancreaticoduodenectomy, including major vascular resections. The most common reasons for readmission were: nausea/vomiting (26%), wound infection (15%), and abdominal pain (18%). Gender, body mass index, duration of operation, blood loss, length of stay, pathology, American Joint Committee on Cancer™ stage, and margin status did not predict readmission. Patients being readmitted were younger (65 vs 69 years, P < 0.001) and had more comorbidities (P < 0.001). Readmission did not curtail long-term survival. Pancreaticoduodenectomy is a complex operation undertaken in patients with notable comorbidities. Readmissions occur frequently after pancreaticoduodenectomy and patients with more comorbidities are at particular risk. Readmissions are not generally the result of complications specific to pancreaticoduodenectomy, but seem more related to ill health, inaccessible nonhospital medical care, and poor expectations. Efforts must focus on patient expectations, intermediate care, home health care, and improving medical care after discharge.

Public perception of LESS surgery and NOTES.

INTRODUCTION: This study was undertaken to determine public attitudes toward laparoendoscopic single-site (LESS) surgery and natural orifice transluminal endoscopic surgery (NOTES) and to determine how they are impacted by age, gender, and obesity. METHODS: One hundred fifty-two citizens completed a validated questionnaire. Pearson correlations were computed to determine relationships among items queried. Scores ranged from 1 (lowest) to 5 (highest) and are presented as median, mean ± SD. RESULTS: The citizens generally liked their physique (4, 4 ± 1.0) and felt attractive (4, 4 ± 1.0). LESS surgery was appealing if it involved no more risk or recovery and none to minimally more pain, operative time, and cost. Older and heavier citizens were more interested in reduced risk, pain, and operative/recovery time and less interested in scarring/appearance. Thirty-nine percent would consider NOTES, though only with no more risk, pain, operative time, and cost (<$200). Older people regarded NOTES more favorably. Lack of scarring with NOTES was most important by only 32% of those participants that would consider undergoing a NOTES procedure. CONCLUSION: Acceptance of LESS surgery and NOTES depends upon no additional risk and no or minimally increased pain, recovery time, and cost. Improved cosmesis is not generally a priority, particularly in older or heavier people. Safety, pain, and recovery time remain major issues in deciding operative choices.

Uncovering the truth about covered stents: is there a difference between covered versus uncovered stents with transjugular intrahepatic portosystemic shunts?

INTRODUCTION: Polytetrafluoroethylene (PTFE)-covered transjugular intrahepatic portosystemic shunt (TIPS) stents purportedly provide superior patency. This study was undertaken to determine whether covered stents provide better long-term patency and outcomes after TIPSs. METHODS: Patients with portal hypertension undergoing TIPS at a large teaching hospital from 2001 to 2010 were studied. Median data are presented. RESULTS: Two hundred forty-six patients underwent TIPS; 70 received uncovered stents, and 176 received covered stents. Patients who received uncovered stents had more severely impaired liver function (41% were Child class C cirrhotics). The follow-up was longer with uncovered stents (48 vs 24 months, P < .01). Reinterventions for stenosis were undertaken in 33% with uncovered stents versus 19% with covered stents (P = .01). Shunt dysfunction occurred in 57% with uncovered stents versus 21% covered (P = .05). A deterioration of hepatic function occurred in 31% with uncovered stents versus 30% with covered (P = .32). Survival with uncovered stents was 31 months versus 33 months with covered stents (P = .55, Kaplan-Meier). CONCLUSIONS: Covered stents may improve patency but do not mitigate postshunt hepatic dysfunction and do not improve survival.

Medical comorbidities should not deter the application of laparoscopic fundoplication.

INTRODUCTION: Laparoscopic Nissen fundoplication offers significant improvement in gastroesophageal reflux disease (GERD) symptom severity and frequency. This study was undertaken to determine the impact of preoperative medical comorbidities on the outcome and satisfaction of patients undergoing fundoplication for GERD. METHODS: Prior to fundoplication, patients underwent esophageal motility testing and 24-h pH monitoring. Before and after fundoplication, the frequency and severity of reflux symptoms were scored using a Likert scale. Medical comorbidities were classified by organ systems, and patients were assigned points corresponding to the number of medical comorbidities they had. In addition, all patients were assigned Charlson comorbidity index (CCI) scores according to the medical comorbidities they had. A medical comorbidity was defined as a preexisting medical condition, not related to GERD, for which the patient was receiving treatment. Analyses were then conducted to determine the impact of medical comorbidities as well as CCI score on overall outcome, symptom improvement, and satisfaction. RESULTS: Six hundred and ninety-six patients underwent fundoplication: 538 patients had no medical comorbidities and 158 patients had one or more medical comorbidities. Preoperatively, there were no differences in symptom severity and frequency scores between patients with or without medical comorbidities. Postoperatively, all patients had improvement in their symptom severity and frequency scores. There were no differences in postoperative symptom scores between the patients with medical comorbidities and those without. The majority of patients were satisfied with their overall outcome; there was no relationship between the number of medical comorbidities and satisfaction scores. These findings were mirrored when patients' CCI scores were compared with satisfaction, overall outcome, and symptom improvement. CONCLUSION: These results promote further application of laparoscopic Nissen fundoplication, even for patients with medical comorbidities.