Evaluation of Indocyanine Green Fluorescence Imaging for Intraoperative Identification of Liver Malignancy.

INTRODUCTION: There is early evidence that indocyanine green (ICG) fluorescence imaging has the ability to detect metastatic and primary malignancies in the liver that are too small to be identified by other methods. However, the rate of false positives and false negatives remains unknown. MATERIALS AND METHODS: This is a single institution prospective single-arm study. Patients with suspected hepatic or pancreatic malignancies were intravenously injected with ICG one to three days prior to their scheduled surgical therapy. At the beginning of the procedure, the liver was assessed with fluorescence imaging and all identified lesions were biopsied and evaluated. RESULTS: Twenty-three patients were enrolled from April 2015 through February 2016. Fifteen patients with confirmed malignancy had adequate fluorescence imaging evaluation of the liver; 10 with pancreatic primary malignancies and five with hepatic primaries. Fluorescence imaging was the only modality that identified nine concerning hepatic lesions, all of which were benign on pathology examination. Out of 11 malignant hepatic masses, six were visible on fluorescence imaging. Out of nine benign hepatic lesions, five were visible. No side effects or complications of the fluorescence imaging were encountered. The sensitivity for ICG fluorescence was 45.5%, the specificity 21.2%, the positive predictive value 25%, and the negative predictive value 40%. CONCLUSION: Intraoperative hepatic assessment with ICG fluorescence imaging to identify malignancy in the liver is feasible and safe. However, in this study the significant number of false positives limit the utility of the technique. Our preliminary data do not support its routine use for detection of malignancies in the liver.

Teaching peroral endoscopic myotomy (POEM) to surgeons in practice: an "into the fire" pre/post-test curriculum.

INTRODUCTION: With the increasing adoption of peroral endoscopic myotomy (POEM) as a first-line therapy for achalasia as well as a growing list of other indications, it is apparent that there is a need for effective training methods for both endoscopists in training and those already in practice. We present a hands-on-focused with pre- and post-testing methodology to teach these skills. METHODS: Six POEM courses were taught by 11 experienced POEM endoscopists at two independent simulation laboratories. The training curriculum included a pre-training test, lectures and discussion, mentored hands-on instruction using live porcine and ex-plant models, and a post-training test. The scoring sheet for the pre- and post-tests assessed the POEM performance with a Likert-like scale measuring equipment setup, mucosotomy creation, endoscope navigation, visualization, myotomy, and closure. Participants were stratified by their experience with upper-GI endoscopy (Novices <100 cases vs. Experts ≥100 cases), and their data were analyzed and compared. RESULTS: Sixty-five participants with varying degrees of experience in upper-GI endoscopy and laparoscopic achalasia cases completed the training curriculum. Participants improved knowledge scores from 69.7 ± 17.1 (pre-test) to 87.7 ± 10.8 (post-test) (p < 0.01). POEM performance increased from 15.1 ± 5.1 to 25.0 ± 5.5 (out of 30) (p < 0.01) with the greatest gains in mucosotomy [1.7-4.4 (out of 5), p < 0.01] and equipment (3.4-4.7, p < 0.01). Novices had significantly lower pre-test scores compared with Experts in upper-GI endoscopy (overall pre-score: 11.9 ± 5.6 vs. 16.3 ± 4.6, p < 0.01). Both groups improved significantly after the course, and there were no differences in post-test scores (overall post-score: 23.9 ± 6.6 vs. 25.4 ± 5.1, p = 0.34) between Novices and Experts. CONCLUSIONS: A multimodal curriculum with procedural practice was an effective curricular design for teaching POEM to practitioners. The curriculum was specifically helpful for training surgeons with less upper-GI endoscopy experience.

Analysis of 340 Patients with Solid Pseudopapillary Tumors of the Pancreas: A Closer Look at Patients with Metastatic Disease.

INTRODUCTION: Current literature addressing the treatment of solid pseudopapillary neoplasms (SPNs) of the pancreas is limited, particularly for patients with distant metastases. We aimed to define predictive indicators of survival in a large series of patients and assess the outcome of patients with distant metastases. METHODS: The National Cancer Database was queried for patients diagnosed with SPNs of the pancreas between 1998 and 2011. Single predictor univariate analyses were performed on variables including demographics, tumor characteristics, and surgery outcomes, and multivariate Cox proportional hazards survival analysis was then completed with backward elimination. RESULTS: Overall, 340 patients were identified: 82% were female, median age was 39 years, and 84% had no comorbidities. Patients undergoing any type of surgical resection experienced long-term survival (85% 8-year survival). Patients undergoing surgical resection (n = 296) had superior survival (hazard ratio [HR] 21 for no surgery, p < 0.0001), as did patients treated at academic centers and those with private insurance (HR 3.9, p = 0.009; HR 4.9, p = 0.007). Sex, age, tumor size, presence of lymph node metastases, positive surgical margins, and presence of distant metastases were not significant predictors of survival in multivariate analysis. Of 24 patients with distant metastases, seven were treated surgically and experienced long-term survival similar to that of patients without metastases treated surgically (HR 2, p = 0.48). CONCLUSION: SPNs of the pancreas are rare neoplasms with excellent overall survival; however, in a low number of patients they metastasize. Of the few patients with metastatic disease selected for resection, most experienced long-term survival.

Characterization of Pancreaticojejunal Anastomotic Healing in a Porcine Survival Model.

INTRODUCTION: Anastomotic leak after pancreaticoduodenectomy is the most important cause of postoperative morbidity and mortality. Histological studies of bowel anastomoses have provided valuable insights regarding causes of anastomotic failure. However, this crucial information is lacking for pancreatico-enteric anastomoses. METHODS: Pancreaticoduodenectomy was performed in a porcine model. Animals were survived up to 10 days and then the pancreatico-enteral anastomosis specimen was resected en bloc. Anastomotic bursting pressure was measured and histological sections of the anastomoses were examined. RESULTS: Six out of 8 animals had excellent healing of the anastomoses. One animal developed a clinically significant leak at the pancreaticoduodenal anastomosis (12.5%) and one animal had a subclinical duodeno-duodenal leak discovered on necropsy (12.5%). Both anastomoses that failed had a collagen-to-tissue ratio less than 40%. In contrast, none of the anastomoses with a ratio greater than 40% showed any evidence of disruption. CONCLUSION: Our results indicate that quantitative measurement of collagen deposition at the pancreatic anastomosis provides objective assessment of healing of the pancreatic anastomosis. A survival porcine model of pancreaticoduodenectomy results in a similar leak rate to published data on pancreaticoduodenectomy in humans and will be useful for future studies assessing novel pharmacologic or technical interventions aimed at improving outcomes.

Novel Simulation Device for Targeting Tumors in Laparoscopic Ablation: A Learning Curve Study.

INTRODUCTION: A novel 3-dimensional (3D) guidance system was developed to aid accurate needle placement during ablation. METHODS: Five novices and 5 experienced hepatobiliary surgeons were recruited. Using an agar block with analog tumor, participants targeted under 4 conditions: in-line with the ultrasound plane using ultrasound, in-line using 3D guidance, 45° off-axis using ultrasound, and off-axis using 3D guidance. Time to target the tumor, number of withdrawals, and the National Aeronautics and Space Administration Task Load Index were collected. Initial and final parameters for each of the conditions were compared using a within-subjects paired t test. RESULTS: A significant reduction was seen in the number of required withdrawals in all situations when using the 3D guidance (0.75 vs 3.65 in-line and 0.25 vs 3.6 for off-axis). Mental workload was significantly lower when using 3D guidance compared with ultrasound both for novices (29.85 vs 41.03) and experts (31.98 vs 44.57), P < .001 for both. The only difference in targeting time between first and last attempt was in the novice group during off-axis targeting using 3D guidance (115 vs 32.6 seconds, P = .03). CONCLUSION: Though 3D guidance appeared to decrease time to target, this was not statistically significant likely as a result of lack of power in our trial. Three-dimensional guidance did reduce the number of required withdrawals, potentially decreasing complications, as well as mental workload after proficiency was achieved. Furthermore, novices without experience in ultrasound were able to learn targeting with the 3D guidance system at a faster pace than targeting with ultrasound alone.

Endoscopic suturing versus endoscopic clip closure of the mucosotomy during a per-oral endoscopic myotomy (POEM): a case-control study.

INTRODUCTION: Obtaining an adequate mucosal closure is one of the crucial steps in per-oral endoscopic myotomy (POEM). Thus far, there have been no objective data comparing the various available closure techniques. This case-controlled study attempts to compare the application of endoscopic clips versus endoscopic suturing for mucosotomy closure during POEM cases. METHODS: A retrospective review of our prospective POEM database was performed. All cases in which endoscopic suturing was used to close the mucosotomy were matched to cases in which standard endoclips were used. Overall complication rate, closure time and mucosal closure costs between the two groups were compared. RESULTS: Both techniques offer good clinical results with good mucosal closure and the absence of postoperative leak. Closure time was significantly shorter (p = 0.044) with endoscopic clips (16 ± 12 min) when compared to endoscopic suturing (33 ± 11 min). Overall, the total closure cost analysis showed a trend toward lower cost with clips (1502 ± 849 USD) versus endoscopic suturing (2521 ± 575 USD) without reaching statistical significance (p = 0.073). CONCLUSION: The use of endoscopic suturing seems to be a safe method for mucosal closure in POEM cases. Closure time is longer with suturing than conventional closure with clips, and there is a trend toward higher overall cost. Endoscopic suturing is likely most cost-effective for difficult cases where conventional closure methods fail.

Trans-oral cricomyotomy using a flexible endoscope: technique and clinical outcomes.

INTRODUCTION: Zenker's diverticulum (ZD) is a rare upper esophageal pathology that is most prevalent in the sixth and seventh decade. Three different therapeutical options are available: (1) open trans-cervical approach, (2) rigid endoscopy and (3) flexible endoscopy. Our hypothesis is that a flexible endoscopic cricomyotomy represents a safe and effective treatment of ZD as well as cricopharyngeal spasm. METHODS: A retrospective analysis of all patients that underwent a flexible endoscopic cricomyotomy at our institution between October 2008 and May 2014 was performed. Preoperative and postoperative (1 month and long-term follow-up) symptom scores and clinical outcomes were collected. Briefly, the ZD is carefully identified endoscopically and the common wall is divided using needle knife cautery with the help of an endoscopic cap. Clips are used to close the mucosal defect starting with the apex. RESULTS: Twenty-six patients underwent a flexible endoscopic myotomy for a ZD. Of 26 patients, five (19.2 %) had a history of previous open or stapled trans-oral myotomy and four (15.4 %) underwent a concomitant foregut procedure. Mean length of stay was 1.5 days (range 1-11). Mean operative time was 68 min (range 28-149). One patient presented with a postoperative leak, and one patient presented with a retained clip. Both were treated endoscopically. Recurrent weekly dysphagia was present in 3/26 (11.5 %). One patient (3.8 %) underwent an endoscopic bougie dilatation postoperatively. With regard to clinical outcomes, there was a statistically significant improvement in both short-term (1 month) and long-term (median follow-up 21.8 months; range 1-68.2 months) dysphagia (p < 0.001; p < 0.001), regurgitation (p = 0.001; p = 0.017), cough (p = 0.006; p = 0.025) and aspiration (p = 0.013; p = 0.013). CONCLUSION: Flexible endoscopic cricomyotomy offers durable relief of dysphagia, regurgitation, cough and aspiration in ZD patients. It appears to have a good safety profile with symptomatic recurrence occurring in up to 11.5 % of cases.

Total pancreatectomy for pancreatic ductal adenocarcinoma: review of the National Cancer Data Base.

BACKGROUND: Total pancreatectomy is infrequently performed for pancreatic cancer. Perceived operative mortality and questionable survival benefit deter many surgeons. Clinical outcomes, described in single-center series, remain largely unknown. METHODS: The National Cancer Database was queried for cases of pancreatic ductal adenocarcinoma undergoing total pancreatectomy (1998-2011). Univariate survival analyses were performed for 21 variables: demographic (8), tumor characteristics (5), surgery outcomes (6), and adjuvant therapy (2). The Log-rank test of differences in Kaplan-Meier survival curves was used for categorical variables. Variables with p < 0.05 were included in a multivariate analysis. Cox proportional hazards regression was used to analyze continuous variables and multivariate models. RESULTS: 2582 patients with staging and survival data made up the study population. 30-day mortality was 5.5%. Median overall survival was 15 months, with 1, 3, and 5-year survival rates of 60%, 22%, and 13%, respectively. Age, facility type, tumor size and grade, lymph node positivity, margin positivity, and adjuvant therapy significantly impacted survival in multivariate analysis. CONCLUSION: Although total pancreatectomy is a reasonable option for selected patients with pancreatic ductal adenocarcinoma, survival of the entire group is limited. Operative mortality is improved from prior reports. Greater survival benefits were seen in younger patients with smaller, node negative tumors resected with negative margins in academic research centers.

Impact of lymph node status in patients with intrahepatic cholangiocarcinoma treated by major hepatectomy: a review of the National Cancer Database.

INTRODUCTION: Routine lymphadenectomy in the surgical treatment of intrahepatic cholangiocarcinoma (ICC) is not routinely performed. We aim to define predictive indicators of survival in patients with positive lymph nodes. METHODS: The National Cancer Data Base (NCDB) was queried for patients who underwent major hepatectomy for ICC between 1998 and 2011. Clinical and pathologic data were assessed using uni- and multi-variate analyses. A sub-analysis was performed on the 160 patients with positive lymph nodes. RESULTS: Of 849 patients with lymph node data, 57% had at least one lymph node examined. Median survival for lymph node negative patients was 37 months versus 15 months for lymph node positive patients. In lymph node positive patients, poorer survival was associated with not receiving chemotherapy (HR 1.83, p = 0.003), tumor size > 5 cm (p = 0.029), and older age (p < 0.0001). Lymph node positive patients age less than 45 had a median survival of 27 months. CONCLUSIONS: Overall survival in patients with lymph node metastases from ICC is poor. Adjuvant therapy was associated with a longer survival in lymph node positive patients, although prospective data are needed. Routine lymphadenectomy should be strongly considered to provide prognostic information and guidance for adjuvant therapy.

20 years later: laparoscopic fundoplication durability.

BACKGROUND: Laparoscopic surgery for gastrointestinal reflux disease was introduced in 1991. Early safety, efficacy, and 5-10-year durability have been amply documented, but long-term patient outcomes have been criticized. This study presents 20-year outcomes after laparoscopic fundoplication (LF) in a consecutive patient cohort. METHODS: Patients who underwent primary LF procedures for gastroesophageal reflux disease (GERD) were identified from a prospectively collected IRB-approved database (1991-1995). A phone symptom questionnaire was administered using a 5-point validated GERD scoring system (heartburn, regurgitation, and dysphagia). Symptomatic success was defined by a lack of surgical re-intervention and a low symptom score. RESULTS: One-hundred and ninety-three patients were identified during the time period. Fifty-one patients completed the survey (100 lost to follow-up, 40 deceased, 2 declined to answer). Respondents had a median follow-up of 19.7 years. Overall, 38/51 (74.5%) of patients reported complete control of heartburn and regurgitation. Ten patients reported only occasional heartburn. Eight of fifty-one (16%) reported daily dysphagia, and 22/51 (43%) of respondents were using proton pump inhibitors at the time of telephone interview. Nine of fifty-one (18%) underwent revision of the original surgery which did not negatively impact the satisfaction rating, with 8/9 (89%) of these patients reporting the highest satisfaction rating. Overall, 46/51 (90%) were satisfied with their choice of surgery. CONCLUSION: Long-term results from the early experience with LF are excellent with 94% of patients reporting only occasional or fewer reflux symptoms at 20-year follow-up. However, 18% required surgical revision surgery to maintain their results. There is a relatively high rate of daily dysphagia but 90% of patients are happy to have had LF.

Early human experience with per-oral endoscopic pyloromyotomy (POP).

INTRODUCTION: Gastroparesis is a condition characterized by delayed gastric emptying, and a constellation of symptoms, including nausea, vomiting, early satiety, and bloating. Although current surgical options such as pyloroplasty have been shown to be effective, an endoscopic submucosal myotomy technique may be applied to divide the pyloric sphincter without surgical access. Such endoscopic technique may provide the benefits of a natural orifice procedure, and improve gastric emptying in gastroparetic patients. METHODS AND PROCEDURES: Per-oral pyloromyotomy (POP) was performed in seven female patients aged 33-65 years (mean 51 years). All patients had a pre-operative work-up that included upper endoscopy, and a gastric emptying study. A pH study, and esophageal manometry were also performed when a concomitant fundoplication was considered. RESULTS: POP was technically successful in all seven cases. There were no immediate procedural complications. Perioperative, complications included: one patient with an upper GI bleed 2 weeks post-procedure, necessitating transfusions, and endoscopic clipping of a pyloric channel ulcer; one patient who experienced difficulty swallowing post operatively, delaying discharge by 1 day; and one patient who developed a hospital-acquired pneumonia, delaying discharge by several days. Six of the seven patients experienced significant symptomatic improvement following the procedure. Three month follow-up nuclear medicine solid-phase gastric emptying studies are currently available for 5 of the 7 patients. Normal gastric emptying at 4 h was noted in four of five patients (80 %). One patient did not respond to endoscopic management subsequently underwent an uneventful laparoscopic pyloroplasty, which also failed to significantly improve her symptoms. CONCLUSION: POP is a technically safe and feasible endoscopic procedure. Early follow-up suggests promising symptomatic improvement as well as objective improvement in gastric emptying. Additional clinical experience is required to establish the role of this technique in the management of gastroparesis.

Multimodal treatment of unresectable hepatocellular carcinoma to achieve complete response results in improved survival.

INTRODUCTION: With technological advances, questions arise regarding how to best fit newer treatment modalities, such as transarterial therapies, into the treatment algorithm for patients with hepatocellular carcinoma (HCC). METHODS: Between 2005 and 2011, 128 patients initially treated with transarterial radioembolization or chemoembolization using drug-eluting beads were identified. The response was graded retrospectively. Toxicity was measured 1, 3, and 6 months after the first and last treatments. RESULTS: Sixty-five patients (53%) were advanced stage. Twenty patients (16%) had an initial complete response, but with additional treatments, this was increased to 46 (36%). Patients with a complete response as their best response to treatment had a median survival [95% confidence interval (CI)] of 5.77 (2.58, upper limit not yet reached) years, significantly longer than those whose best response was a partial response, 1.22 (0.84, 2.06) years and those with stable disease as their best response, 0.34 (0.29, 0.67) years. Repeated treatments did not increase toxicity. DISCUSSION: This retrospective review of patients treated for intermediate and advanced stage HCC revealed a significant survival advantage in patients who achieved a complete response. These data support use of a multi-modality approach to intermediate and advanced stage HCC, combining liver-directed treatments as necessary to achieve a complete response.

Neoadjuvant radiation therapy and its impact on complications after pancreaticoduodenectomy for pancreatic cancer: analysis of the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP).

OBJECTIVES: This study investigated the impact of neoadjuvant radiation therapy (XRT) on postoperative outcomes following pancreaticoduodenectomy for pancreatic cancer. METHODS: The American College of Surgeons National Quality Improvement Program database was queried for the period 2005-2010 to assess complication rates following pancreaticoduodenectomy for pancreatic cancer. Two groups of patients were identified, comprising those who received neoadjuvant XRT and those who did not (control group). RESULTS: A total of 4416 patients were identified, including 200 in the XRT group and 4216 in the control group. There were differences in patient characteristics between the groups, including in age, hypertension and bilirubin level. Despite the fact that weight loss was more common, median operative time was longer (423 min versus 368 min; P < 0.001), and vascular reconstruction was more commonly required (20.5% versus 8.4%; P < 0.001) in the XRT group. In addition, the XRT group had a shorter median hospital stay than the control group (9 days versus 10 days; P = 0.005). Mortality (3.0% versus 2.7%; P = 0.818) and morbidity (40.5% versus 37.6%; P = 0.404) rates were not influenced by neoadjuvant XRT. Blood transfusion rates were increased in the XRT group (13.0% versus 7.4%; P = 0.003). Severe complications were influenced by age >70 years, American Society of Anesthesiologists (ASA) class >2, preoperative sepsis, dyspnoea, weight loss, impaired functional status, peripheral vascular disease and operative time of >8 h. CONCLUSIONS: Neoadjuvant XRT is not associated with an increase in complications after pancreaticoduodenectomy.

Laparoscopic radiofrequency ablation for the management of colorectal liver metastases: 10-year experience.

BACKGROUND: Published results addressing the treatment of colorectal liver metastases (CRLM) with radiofrequency ablation (RFA) vary widely with local recurrence rates of 2-40% and 5-year survival of 14-55%. The goal of this study was to analyze our 10-year experience with laparoscopic RFA. METHODS: From January 2000 to July 2010, 130 patients underwent laparoscopic RFA for CRLM. Kaplan-Meier analysis was used to assess survival. Univariate and multivariate analysis were performed to identify factors associated with survival and recurrence. RESULTS: In this cohort, median survival was 40.4 months with 5-year survival of 28.8%. Overall, 9.2% of patients had a local recurrence (3.6% for tumors 3 cm or less). On univariate analysis, factors associated with decreased survival were BMI (P = 0.045), rectal primary (P = 0.005), and increased tumor size (P = 0.002). On multivariate analysis, increased tumor size (HR 1.29 [95% CI: 1.04-1.59]; P = 0.020) and bilobar disease (HR 2.06 [95% CI: 1.02-4.15]; P = 0.044) were associated with decreased survival. On univariate analysis, only BMI was found to be associated with disease recurrence (P = 0.025). CONCLUSIONS: Our data demonstrate that laparoscopic RFA can achieve a median survival of 40.4 months with a low local recurrence rate. Patients with tumors 3 cm or less have a decreased risk of local recurrence.

Data-based self-study guidelines for the fundamentals of laparoscopic surgery examination.

BACKGROUND: In preparing for the fundamentals of laparoscopic surgery (FLS) exam, residents usually adopt a self-learning strategy where practice time can be managed with more flexibility. However, with this self-learning strategy, there is a lack of direct supervision from experts and residents risk understudying for this high-stakes exam. Our objective is to determine study goals for effective self-guided practice for the FLS manual skills tasks that will result in passing the examination. METHODS: FLS manual skills data for all PGY-5 residents during 2009-2010 was supplied by the FLS administrative office. Descriptive statistics were performed, and data were regrouped by the pass/fail results of the exam. The minimum practice time requirement for passing each manual skills task is reported in order to guide practice. RESULTS: 1,047 proctored FLS exams were completed by 2009-2010 residents. Mean task time achieved by all residents was 84 ± 31 s for peg transfer, 139 ± 54 s for pattern cut, 78 ± 29 s for endoloop, 158 ± 66 s for extracorporeal suturing, and 168 ± 77 s for intracorporeal suturing. In the pass group (n = 988), mean time to complete each task was 80 s for peg transfer, 134 s for pattern cut, 75 s for endoloop, 148 s for extracorporeal suturing, and 160 s for intracorporeal suturing. Calculations suggest a self-study goal for each task of 53 s for peg transfer, 50 s for pattern cut, 87 s for endoloop, 99 s for extracorporeal suturing, and 96 s for intracorporeal suturing. If a resident can reliably achieve these results during self-study, they have an 84% chance of passing the exam. CONCLUSIONS: Residents preparing to take the FLS exam can refer to data presented in this study to set practice goals. Referring to these data-based practice goals will help residents to improve their chances of passing this high-stakes exam.

Postoperative dysphagia is not predictive of long-term failure after laparoscopic antireflux surgery.

INTRODUCTION: Dysphagia is a common postoperative symptom after laparoscopic antireflux surgery, usually attributed to postoperative edema or a "too tight" fundoplication. Although it is usually self-limited, it occasionally requires endoscopic dilation and rarely revisionary surgery. It has not been previously described whether postoperative dysphagia is associated with poorer long-term reflux control after fundoplication. METHODS: We hypothesized that the presence of dysphagia in the early postoperative period is associated with long-term failure of the antireflux procedure and recurrence of gastroesophageal reflux disease (GERD) symptoms. A retrospective review of a prospectively maintained database of patients undergoing antireflux surgery was performed. The study population included patients, who underwent primary laparoscopic Nissen fundoplication between the years 1991 and 2010. The presence of dysphagia on their first postoperative visit (<30 days) was used to classify them in the early-dysphagia (ED) and the no-early-dysphagia (NED) groups. The recurrence of heartburn or regurgitation, as well as the pH studies on long-term follow-up (more than 6 months) were compared between the two groups. A grading system (range 0-4) was used to measure the severity of foregut symptoms. RESULTS: 1223 patients underwent primary laparoscopic Nissen fundoplications during the study period and met the inclusion criteria. Both short and long-term follow-up was available in 821 patients, who were analyzed. 423 patients were included in the ED group, whereas 398 in the NED group. The mean regurgitation score of the ED group on the long-term follow-up was 0.25 compared to 0.20 for the NED group (P = 0.21). The heartburn score was 0.38 for the ED group compared to 0.33 for the NED group (P = 0.38). Long-term dysphagia was higher in the ED group. These findings were confirmed when ED patients were subclassified based on the degree of early post-operative dysphagia. Of the 821 patients, 599 underwent routine postoperative pH testing. The mean DeMeester score in the ED group (n = 308) was 11.7 compared to 13.2 for the NED group (n = 291; P = 0.54). The percentage of patients with abnormal pH testing was similar between the two groups. CONCLUSIONS: Early postoperative dysphagia is not associated with worse long-term GERD symptom control after primary laparoscopic antireflux surgery.

Quantifying mental workloads of surgeons performing natural orifice transluminal endoscopic surgery (NOTES) procedures.

BACKGROUND: During natural orifice transluminal endoscopic surgery (NOTES), surgeons often have difficulties orienting the surgical view and manipulating instruments accurately, which increases their level of mental and physical fatigue. This study quantified mental workload by measuring the spared mental resources of surgeons performing NOTES training tasks. METHODS: Assessment of mental workload was conducted in both a benchtop and a hybrid animal model. Using the benchtop model, surgeons were required to pass a ring as many times as possible in 6 min. Using the hybrid model, surgeons were required to dissect the gallbladder. While performing those primary tasks, the surgeon was required to identify true visual signals among many false signals displayed on an adjacent monitor. They were asked to repeat the trials using laparoscopy. The surgeons' performance on the primary and secondary tasks using the NOTES and laparoscopic approaches were recorded and compared. RESULTS: The nine surgeons who completed the trials in the benchtop model successfully transferred 13 ± 4 rings between targets using laparoscopy compared with a mean of 1.2 ± 1.0 rings transferred using NOTES (P < 0.001). The surgeons detected visual signals at a 74% rate using laparoscopy, which was significantly higher than the 54% detection rate with the NOTES procedure (P = 0.005). Using the hybrid model, 10 surgeons achieved a 55% accuracy rate performing the laparoscopic task. This was found to be significantly higher (P = 0.006) than when the task was performed using the NOTES platform (39%). CONCLUSION: The results showed that performance of a task using the NOTES platform increases surgeons' mental workload. Because difficulty performing NOTES is associated with flexible endoscopy, the authors expect that new operating systems providing stable platforms will help to decrease the mental workload of surgeons and enhance eye-hand coordination in performing NOTES.

Optimizing surgical approach for natural orifice translumenal endoscopic procedures.

BACKGROUND: Natural orifice translumenal endoscopic surgery (NOTES) often requires some degree of retroflexion of the endoscopic operating system. This study investigates the impact of retroflexion on task performance in NOTES. METHODS: In a bench-top simulation, surgeons were required to manipulate a single-channel endoscope to touch 4 dots in a predetermined order. The task was performed under the forward-view and retroflexed-view conditions. RESULTS: Tasks performed under the forward-view condition were significantly faster than those performed under the retroflexed-view condition (P = .005). Also, 5 experienced surgeons completed tasks in less time than the novices (P = .043). Experienced surgeons were mildly affected by the inverted image, whereas the novices were vulnerable to image malalignment. CONCLUSION: Careful selection of the surgical approach to avoid image malalignment is suggested for safe performance of NOTES. Extensive training is required for novices to overcome the vision-motion difficulty before they can perform NOTES safely and effectively.

Randomized controlled trial comparing single-port laparoscopic cholecystectomy and four-port laparoscopic cholecystectomy.

OBJECTIVE: To compare short-term surgical outcomes and quality of life (QOL) between single-port laparoscopic cholecystectomy (SPLC) and classic 4-port laparoscopic cholecystectomy (CLC). BACKGROUND: There is significant interest in further reducing the trauma associated with surgical procedures. Although a number of observational studies have suggested that SPLC is a feasible alternative to CLC, there is a lack of data from randomized studies validating any benefit over CLC. METHODS: Eligible patients were randomized to receive SPLC or CLC. Operative and perioperative outcomes, including cosmesis and QOL were analyzed. RESULTS: Forty-three patients were randomized to SPLC (n = 21) or CLC (n = 22). There were no significant differences between groups for most preoperative demographics, American Society of Anesthesiology score, gallstone characteristics, local inflammation, blood loss, or length of stay. Patients undergoing SPLC were older than those receiving CLC (57.3 years vs. 45.8 years, P < 0.05). Operative times for SPLC were greater than CLC (88.5 minutes vs. 44.8 minutes, P < 0.05). Overall and cosmetic satisfaction, QOL as determined by the SF-36 survey, postoperative complications, and post-operative pain scores between discharge and 2-week postoperative visit were not significantly different between groups. Wound infection rates were similar in both groups. The SPLC group contained 1 retained bile duct stone, 1-port site hernia, and 1 postoperative port site hemorrhage. CONCLUSIONS: SPLC procedure time was longer and incurred more complications than CLC without significant benefits in patient satisfaction, postoperative pain and QOL. SPLC may be offered in carefully selected patients. Larger randomized trials performed later in the learning curve with SPLC may identify more subtle advantages of one method over another.

Outcome after laparoscopic radiofrequency ablation of technically resectable colorectal liver metastases.

BACKGROUND: There continues to be controversy surrounding the appropriate use of radiofrequency ablation (RFA) for the treatment of colorectal liver metastases (CRLM). This study analyzes outcomes data of CRLM patients who underwent laparoscopic RFA. Outcomes of patients determined to be technically resectable were compared to patients with unresectable disease. METHODS: Data from all patients with CRLM who underwent laparoscopic RFA between 1996 and 2006 were retrospectively reviewed. A blinded independent hepatobiliary-trained surgical oncologist reviewed preoperative diagnostic imaging studies to determine resectability. Outcomes data for patients with disease deemed anatomically resectable and unresectable were analyzed and compared. Survival was calculated by the Kaplan-Meier method. The log rank test was performed to assess significance in survival. RESULTS: A total of 113 patients who underwent laparoscopic RFA for CRLM were identified. Twelve patients who underwent concurrent hepatic resection were excluded. Of the remaining patients, 64 were determined to have disease that was be technically resectable and 37 unresectable as a result of tumor number and/or distribution. Median and 5-year survival of the potentially resectable group was 4.3years and 48.7%, compared to 2.2 years and 18.4% in the unresectable group (P = 0.002). Median disease-free survival in the resectable group was 15.0 months, compared to 16.4 months in the unresectable group (P = 0.796). No postoperative mortality was reported in the technically resectable group, and the rate of major complications was 3.1%. CONCLUSIONS: Laparoscopic RFA of resectable CRLM can produce comparable long-term survival to hepatic resection in carefully selected patients, with favorable morbidity and mortality.